Copyright Arbour Group https://test-arbour-group.marceldigital.com Thu, 18 January 2018 12:46:28 Thu, 18 January 2018 12:46:28 Aaron Turransky https://test-arbour-group.marceldigital.com/blog/2018/january/18/test-2018/ Test  2018 https://test-arbour-group.marceldigital.com/blog/2018/january/18/test-2018/ https://test-arbour-group.marceldigital.com/blog/2018/january/18/test-2018/ Thu, 18 January 2018 12:46:28 https://test-arbour-group.marceldigital.com/blog/2015/september/the-impact-of-the-medical-device-market-growth/ What is a Medical Device? A medical device is an instrument, apparatus, implant, reagent or similar article that is used to diagnose, prevent or treat diseases or other conditions. It is not a drug, therefore it does not achieve its purposes through chemical action within or on the body. Packaging these devices is a key component of the medical device market to ensure safety and sterility. While specific personnel are handling the devices, it is important to keep the devices protected during the distribution and handling processes. The awareness of the need for extra precaution for these medical devices is leading to positive growth in the packaging industry. Expected Medical Device Market Growth Analysts forecast that the Global Medical Device Packaging market is expected to grow at a compound annual growth rate of 5.92% from 2013-2019. This is good news for different industries and products on the market because there are many opportunities for success. The Global Medical Device Packaging market can be divided into seven segments on the basis of types by application: Surgical Appliances and Supplies Packaging Surgical and Medical Instruments Packaging Dental Devices Packaging Ophthalmic Devices Packaging Electro-medical Devices Packaging Medical Apparatus Packaging Others Adopted Technology Reason for Market Growth The key customers of this market are medical device manufacturers, diagnostic centers and hospitals. There have been many reports done concerning the details of the major drivers, challenges and trends of this market. The increased adoption of technology is a major trend in the market. Examples of some application products can range from containers, pouches, glass vials and multiple compartment trays. Strict regulations apply to medical device packaging in order to maintain sterilization. There is definitely room for creativity and innovation for new products on the market and the different industries involved. https://test-arbour-group.marceldigital.com/blog/2015/september/the-impact-of-the-medical-device-market-growth/ https://test-arbour-group.marceldigital.com/blog/2015/september/the-impact-of-the-medical-device-market-growth/ Tue, 22 September 2015 09:00:00 https://test-arbour-group.marceldigital.com/blog/2015/september/how-to-use-the-fda-udi-database/ What is UDI?  The Global Unique Device Identification Database (GUDID) is a place to store information about different medical devices in a way that is clear and concise. It serves as a reference catalog for every device with an identifier. Medical devices cover a wide range of products, so the GUDID was created to give medical devices a unique identifier that clearly distinguishes one product from another. The database will be utilized by healthcare providers and patients and most of the information will be open to the public through  AccessGUDID .   How UDI Works The UDI system will provide a consistent and standard way for medical devices throughout their distribution and use for a variety of people. Understanding the process of how the system works is important before moving forward. The FDA has issued the complete  Global Unique Device Identification Database (GUDID): Guidance for Industry . According to the FDA, this document describes key GUDID elements such as account management, user roles, the device identifier (DI) module, DI record life-cycle, package configurations and the two GUDID submission options (web interface and HL7 SPL). The FDA is encouraging labelers to refer to the guidance document and begin submitting necessary data to the GUDID. There are also more technical documents that can be found on the FDA  website that can assist different industries with the requirements they need in order to fully comply with the UDI requirements.   Benefits of UDI The GUDID provides a resource to report adverse effects of devices and hasten reactions to recalls. The UDI system allows for more accurate reporting, reviewing and analyzing of adverse event reports so that problems can be identified and corrected in a timely manner. It will enable manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls. UDI implementation will improve patient safety, modernize device post market surveillance and facilitate medical device innovation. Arbour Group's experienced professionals are extensively trained to evaluate a client's readiness as well as assist with UDI Compliance . If you have questions about UDIs or UDI compliance, the experts at Arbour Group are here to help . https://test-arbour-group.marceldigital.com/blog/2015/september/how-to-use-the-fda-udi-database/ https://test-arbour-group.marceldigital.com/blog/2015/september/how-to-use-the-fda-udi-database/ Thu, 17 September 2015 16:04:08 https://test-arbour-group.marceldigital.com/blog/2015/the-evolution-of-api-testing-application-and-healthcare-based-industries/ What is an API? API, also known as Application Program Interface, is a set of routines, protocols and tools for building software applications. A good API makes it easier to develop a program by providing all of the necessary building blocks. Once a substantial API is developed, a programmer then comes in and puts all of the blocks together for a more complete product. There are a wide variety of APIs for websites, applications and operating systems. Some popular API examples are Google Maps API, YouTube APIs and Amazon Product Advertising API. Testing your API is necessary for both application and healthcare based industries because the type of technology being used needs to be safe and reliable.   API Testing in  Application Industries It is crucial for application industries to test their APIs because the information that they provide needs to be secure and accurate. A common misconception about API testing is that there isn’t a need to test APIs until there is a problem. Even though the information on a software application may be utilized properly, the accuracy can be incorrect. Incorrect or flawed data is referred to as contaminated data. Contaminated data is one of the most common errors today. There are many ways a contamination can happen, so testing APIs within the application industry and any other industry is crucial. Data integrity is important for companies to maintain, therefore a company should not hold off on performing API testing.   API Testing in Healthcare Industries Healthcare industries should always test their APIs because they are constantly dealing with sensitive information. For starters, patient information is at the heart of all medical operations. This information can range from billing information to vital statistics and diagnosis. Regardless of the content of the information, it should always remain confidential. With technology constantly evolving, more and more sensitive information is being transferred online. If APIs are sharing patient information with either in-house applications or third parties, then the protocol must be tested for security. Within healthcare industries, patient care and business go hand in hand. Doctors, nurses and other medical personnel are continually utilizing software and browser-based applications that utilize APIs for various functions. Information regarding medical research, file sharing and communication are utilized through APIs. APIs are an important part of business within the healthcare industry, but more importantly, they are a critical part of patient treatment based industries. If you have any questions or need a help navigating the ever changing world of API testing, feel free to take a look at the different industries that Arbour Group works with, or reach out to us and we will gladly help where we can! Arbour Group has over 20 years of assuring life science compliance companies, providing solutions that fit your business needs and meets risk management needs by meeting applicable FDA and international regulations as well as industry best practices. https://test-arbour-group.marceldigital.com/blog/2015/the-evolution-of-api-testing-application-and-healthcare-based-industries/ https://test-arbour-group.marceldigital.com/blog/2015/the-evolution-of-api-testing-application-and-healthcare-based-industries/ Tue, 15 September 2015 09:00:00 https://test-arbour-group.marceldigital.com/blog/2015/september/09/qad-chooses-ibm-for-cloud-service-in-australia/ Who is QAD? QAD, Inc., a software company that provides Enterprise Resource Planning (ERP) software to manufacturing companies around the world, has been an effective enterprise for almost 35 years.  QAD has recently chosen IBM’s Cloud Centre in Sydney, Australia to expand hosting options for QAD Cloud ERP customers. High Cloud ERP Demand QAD is expanding its data center services in response to demand from Australian and New Zealand companies that are transitioning from on premise ERP to Cloud ERP. QAD is clearly displaying commitment to the region by providing clients with local hosting in Australia. They believe that the cloud is not merely an expansion option, but rather a strategic decision. The Benefits of a QAD Cloud ERP and IBM Integration Expanding QAD Cloud ERP through IBM’s globally integrated network of cloud centers provides users many benefits. QAD data centers are ISO certified and carry SSAE 16 SOC 2 certification, which is considered the highest international standard. QAD Cloud ERP enables manufacturers to meet compliance requirements, support global growth and expansion, access and analyze data and access a variety of manufacturing features on the cloud. Users that do business in Australia can feel confident that QAD will provide exceptional service to support their businesses. Have Questions? Arbour Group life sciences industry regulatory experts continually work to ensure that your company is compliant with domestic and international authorities. If you have any questions, comments, or concerns, feel free to review our QAD compliance solutions , or contact us today! https://test-arbour-group.marceldigital.com/blog/2015/september/09/qad-chooses-ibm-for-cloud-service-in-australia/ https://test-arbour-group.marceldigital.com/blog/2015/september/09/qad-chooses-ibm-for-cloud-service-in-australia/ Wed, 09 September 2015 17:16:02 https://test-arbour-group.marceldigital.com/blog/2014/software-testing-and-quality-assurance-emphasis-in-new-areas/ New Focus Areas for Quality Assurance and Software Testing One of the top priorities of any corporate IT organization is always software testing and quality assurance. Shipping a product is one thing – making sure that it is free from bugs and other issues that could negatively affect the end user experience is something else altogether. A new trend in IT priorities, however, has the emphasis on software testing and quality assurance moving towards new areas that feature newer types of technology than what was commonly worked with in the past. Where Are the New Focus Areas? More specifically, social media, mobile applications, cloud applications and other types of new technology are seeing an increased emphasis in today's modern landscape, all of which point to a currently evolving enterprise IT landscape when compared to the same situation even a few short years ago. A survey of over 1500 CIOs that was conducted by Capgemini revealed that for the first time in the history of IT, a larger amount of money was being spent on "new technology" than it was on existing systems and practices. Maintaining legacy systems and applications is being put on the proverbial back burner in favor of advancements like social integration, the mobile environment, powerful data analytics, cloud computing and more. Focus Areas Taking Up Share of Budget The study is all the more interesting when you discover that software testing and quality assurance now represents over 25 percent of the total average IT budget. In 2012, these factors only represented 18 percent of the total budget. That share is expected to continue to grow and could reach almost 30 percent by as soon as 2017. To take things a step farther, the testing and quality assurance process for totally new applications now makes up 52 percent of the overall testing budget. This means that legacy systems of all types are becoming less and less important to major companies as time goes on. What Does This Mean for You and Your Clients? These developments mean a number of interesting things for both existing and future clients. For starters, they point towards an increased emphasis on the adoption of new technology across the board. The fact that legacy systems are no longer seeing the type of attention they once did points to a major shift towards the types of systems and technologies that will be available to clients moving forward. It also means that once those new deployments like cloud computing functionality are rolled out, however, they will have a dramatic level of support to help make sure that everything is operating at peak effectiveness. Not sure what areas to expand assurance solutions and emphasis to? Feel free to contact us and we can help! https://test-arbour-group.marceldigital.com/blog/2014/software-testing-and-quality-assurance-emphasis-in-new-areas/ https://test-arbour-group.marceldigital.com/blog/2014/software-testing-and-quality-assurance-emphasis-in-new-areas/ Thu, 06 November 2014 00:00:00 https://test-arbour-group.marceldigital.com/blog/2014/sap-partners-with-birst-inc/ SAP and Birst Partnership SAP, the European software giant, announced on October 9, 2014 its intention to team up with Birst, a cloud service provider for businesses intelligence (BI.) The goal of this partnership is to provide customers instant computer data, stored in the cloud via SAP's HANA cloud platform. According to Brad Peters, chairman and chief product officer at Birst, "the real opportunity in BI lies in our ability to push data to the front lines, empowering every person to make every decision better." About the SAP/Birst Merger Germany-based SAP, which launched its first software product in 1973, is one of the largest software companies in the world. Its SAP HANA, released in 2010, gives businesses in-memory access to real-time analytics. Birst Inc., founded in 2004, is a San Francisco-based cloud-based business intelligence company. Birst sells to both original equipment manufacturers and to companies, like Motorola and American Express, who use the Birst software analytics suite within their own software system. What does the SAP/Birst partnership mean for current and potential customers? The chief initial benefit of the SAP/Birst partnership to SAP customers is the ability to access analytics instantly from multiple locations, rather than having to wait for periodic updates and having the analytics dashboard limited to use on a single server. By storing this data in the cloud, companies can access information from anywhere an authorized person has an Internet-enabled device. In addition, multiple users can view the data at the same time and data doesn't require increased server space. Birst cloud software allows SAP HANA users to customize their own data warehouse within the SAP HANA platform. This gives customers not only instant access to data, but instant access to exactly the data they use on a regular basis. While the exact results of the SAP/Birst partnership remain to be seen, the coming together of these two computer leaders will likely yield exciting possibilities. If you have comments or questions as to how this merger may affect you and your business, feel free to contact us today! https://test-arbour-group.marceldigital.com/blog/2014/sap-partners-with-birst-inc/ https://test-arbour-group.marceldigital.com/blog/2014/sap-partners-with-birst-inc/ Tue, 04 November 2014 18:43:00 https://test-arbour-group.marceldigital.com/blog/2014/sap-se-acquires-concur-technologies/ SAP SE, the German enterprise software vendor, made the news on September 18th after they announced their plans to acquire Concur Technologies for a price tag of $8.3 billion, making this the biggest purchase SAP has ever made. Concur Technologies is considered a leading provider of expenses management and cloud-based travel solutions. Why Concur Technologies? SAP already offers specialized software services on its computing networks. With the purchase of Concur, SAP will be able to increase its online product offerings as well as strengthen its position in the travel sector which should result in increased software revenue. The acquisition will likely be an efficient way for Concur to scale its business in locations outside of the United States and to sell what it offers in the way of business travel solutions to all of the SAP customers that don't already use Concur. However, it is also apparent that SAP is planning to make it a priority to sell their business enterprise solutions to customers of Concur. SAP Cloud Growth The primary motivation for this purchase by SAP is to accelerate cloud growth. Concur is considered the leading innovator in the corporate travel industry. This cloud- based provider of expense management and integrated travel solutions currently has 20,000 clients worldwide and is used by over 25 million individuals. With this acquisition, SAP has plans to strengthen the presence it already has in the networked economy Along with Ariba, which was purchased by SAP in 2012 for $4.3 billion, the integration of Concur Technologies expense management and travel offerings are planned to expand the company in total transactions each year across 25 different industries. The acquisition of Concur will increase the SAP cloud users population from 38 million to 50 million. https://test-arbour-group.marceldigital.com/blog/2014/sap-se-acquires-concur-technologies/ https://test-arbour-group.marceldigital.com/blog/2014/sap-se-acquires-concur-technologies/ Thu, 09 October 2014 18:52:00 https://test-arbour-group.marceldigital.com/blog/2014/oracle-s-bluekai-acquisition-what-it-means/ On July 22, 2014 Oracle announced their new Oracle Data Cloud service. The most significant piece of this service came with their February 2014 acquisition of BlueKai for between $350 and $400 million. Prior to the acquisition, BlueKai provided a market leading Data Management Platform (DMP). BlueKai’s acquisition filled out the company’s reach into the marketing, advertising, and personalization area of the cloud thanks to other recent acquisitions like social marketing solutions provider Vitrue, marketing automation firm Eloqua, campaign management solutions provider Responsys and content marketing from Compedium. Oracle took all these acquisitions and formed the basis of their Data as a Service (DaaS) offerings for Marketing and Social. These allow companies to combine all their internal data stored in Oracle databases with the personalization information available externally in the Oracle Data Cloud. The combined platforms create actionable profiles that compete with the offerings from Adobe and Salesforce.com. From a sheer numbers perspective, Oracle DaaS for Marketing adds access to over 1 billion user profiles globally. With Oracle DaaS for Social, over 700 million messages from 40 million social media and news sites are analyzed through text analysis. Combined, the Oracle Data Cloud service provides identity management, allowing a strong platform for prospecting with targeted advertising, marketing, and sales campaigns. Event talent management is an option. Another key benefit that Oracle Data Cloud offers, thanks to the BlueKai acquisition, is related to privacy and legal controls. Instead of companies trying to deal with all the complex laws and regulations pertaining to profiling and targeted offerings, Oracle Data Cloud delivers customers actively looking for your services. https://test-arbour-group.marceldigital.com/blog/2014/oracle-s-bluekai-acquisition-what-it-means/ https://test-arbour-group.marceldigital.com/blog/2014/oracle-s-bluekai-acquisition-what-it-means/ Thu, 25 September 2014 18:56:00 https://test-arbour-group.marceldigital.com/blog/2014/building-an-effective-compliance-strategy/ Running a business entails handling everything from developing products, creating sales strategies, employee training and handling customer/client service requests. Because there are so many things on which to focus, some businesses overlook the need for an effective compliance strategy. Compliance guidelines ensure companies act responsibly in key aspects of their business. It also keeps the company operating within all legal guidelines Requirements There are a variety of factors that go into establishing an effective compliance strategy. It may take a lot of work and effort in the beginning, but once everyone in the company is following proper compliance procedures, it will become a natural part of the company's day-to-day business. Here are some requirements needed when building a compliance strategy: Example: Those in management need to lead by example and have a strong commitment to ensure the company remains compliant. Evaluations: Check current operations and see where there are compliance issues already existing. Education: Lean about industry standards and areas where the business needs to remain compliant. Experience: Get outside help from experienced consultants, including lawyers, insurance companies and other service providers. Employees: All employees must be compliant from the moment they are hired. Establish a department: Set up a compliance department or team that focuses on issues, training and learning about changes in regulations. Actions After evaluating current operations and determining the areas where compliance issues exist, it is important to develop an action plan. Make a list with three categories – fully compliant, partially compliant and not compliant. Write down each area of business operations that need to be compliant under the appropriate category. Start taking action on those areas listed under "not compliant" first. Determine which aspects are not within regulation and find out why. Write down what needs to be done to bring these areas up to compliant levels. Sometimes, not being compliant can be as simple as needing paperwork completed or having employees get recertified. Focus on brining all of these up-to-date. Next, move onto those areas listed under "partially compliant." These should be areas that need only one or two things corrected to bring them up to par. Finally, areas listed under "fully compliant" can be set aside. However, this list should not be forgotten. It needs to be reevaluated regularly to ensure everything remains compliant. Timing Depending upon how much work needs to be done to bring everything up to the appropriate compliance levels, it could take some time. Determine when each item needs to be corrected and create a time table. It may be necessary to work a little bit on each area every day. Maintenance Once everything is brought up to a compliant level, it is important to keep a compliance calendar. This calendar should include when audits are scheduled, when a recertification needs to be completed, etc. It is also a good idea to regularly check everything to ensure nothing has fallen into the "not compliant" category. This can be done monthly or quarterly. Compliance should be part of a business's day-to-day operations. Non-compliance can mean hefty fines or lawsuits if an adverse event should occur. Taking the time to ensure everything is in order will reduce the chances of having to pay fines and settlements. https://test-arbour-group.marceldigital.com/blog/2014/building-an-effective-compliance-strategy/ https://test-arbour-group.marceldigital.com/blog/2014/building-an-effective-compliance-strategy/ Tue, 23 September 2014 19:01:00 https://test-arbour-group.marceldigital.com/blog/2014/third-party-logistics-3pl-providers-what-you-need-to-know/ Third Party Logistics (3PL) Providers Pharmaceutical companies rely heavily on third party logistics providers as critical components of their supply chain. With the pharmaceutical industry being one of the most strictly regulated industries globally, 3PL providers must adhere to applicable guidelines established by government and state agencies to ensure pharmaceutical manufacturers that they are in compliance with these regulations. External Threats The World Health Organization recently reported that nearly 10 percent of pharmaceutical products may be counterfeit and that two percent of drugs manufactured in the U.S. are consistently diverted or stolen (http://www.contractpharma.com/issues/2007-11/view_features/the-high-cost-of-selecting-a-low-cost-3pl-provider/#note2). Consequently, pharmaceutical companies are at risk for losing as much as half of their revenue associated with the transportation of products. This means that 3PL providers licensed to work with pharmaceuticals must implement and practice superior forms of supply chain security to ensure products are transported without interference from criminal activity. Internal Threats Internal deficiencies also threaten the viability of pharmaceutical companies involved with non-compliant 3PL providers. Inadequately developed systems, lack of employee discipline and other quality control issues can easily arise anywhere along the supply chain artery that compromises the integrity of life science products. In addition, most non-licensed providers typically fail to properly train and educate employees who must handle pharmaceutical/life science products that demand specialized treatment or suffer possible degradation during transportation. Deep inefficiencies affecting a 3PL provider who collaborates with pharmaceutical companies can cost life science industries millions in revenue as well as risk implementation of steep fines for noncompliance. Drug Quality and Security Act In the near future, 3PL providers will need licensing as described in the Drug Quality and Security Act . Specifically, Title II of this act– Drug Supply Chain Security –"establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain (http://beta.congress.gov/bill/113th-congress/house-bill/3204). In fact, the FDA plans to enact reporting obligations by 3PL providers to the FDA starting November 27, 2014 (http://pharmaceuticalcommerce.com/supply_chain_logistics?articleid=27130). For 3PL Providers, the DQSA Means Implementing Several Important Changes: 1. Third party logistics companies will be subject to a federally regulated system involving the exchange of "traceable information" and verification of all transaction histories. 2. Third party logistics providers will no longer be able to operate under state licensing requirements that are "inconsistent with or less stringent" than requirements established by federal licensing standards. 3. The redefining of 3PL providers states that: "a 3PL provider…indicates an entity that coordinates…logistic services of products in interstate commerce…but does not own the product…or have responsibility to direct the disposition or sale of the product" (http://www.fdli.org/docs/dqsa-2014/e-jungman_fdli-dqsa-2-20-14.pdf?sfvrsn=0). Establishment of National Licensure Standards for 3PL Providers Licensing requirements for 3PL providers under the Drug Quality and Security Act include: They must have a valid license from the state in which the drug is being distributed or is being distributed into . If a state cannot license according to federal standards, then the 3PL provider must obtain a license from the U.S. FDA. In the event a state cannot license a 3PL provider, the FDA will implement a third-party accreditation program. However, according to the guidelines of the DQSA, "if no accreditor is approved, the FDA will license a 3PL provider directly" ( source ). https://test-arbour-group.marceldigital.com/blog/2014/third-party-logistics-3pl-providers-what-you-need-to-know/ https://test-arbour-group.marceldigital.com/blog/2014/third-party-logistics-3pl-providers-what-you-need-to-know/ Thu, 24 July 2014 19:06:00 https://test-arbour-group.marceldigital.com/blog/2014/drug-supply-chain-security-act-title-ii/ In order to maintain the U.S. drug supply chain as the world's safest, Congress enacted the Drug Supply Chain and Security Act (DSCSA) in 2013. The Act has specific requirements to prevent threats to the supply chain and maintain the integrity of drugs that are distributed within the U.S. The new law does away with piecemeal and inconsistent state laws and establishes national standards for all entities within the drug supply chain. Some new requirements for the identification, tracing and tracking of pharmaceutical products will take effect beginning January 1, 2015, with 10 years allowed for full implementation. The FDA safeguards are intended to prevent substandard, altered or counterfeit drugs from entering the distribution chain. The safeguards also will provide consumers with access to drugs which are safe and effective. Cargo theft will be thwarted and counterfeiting identified. When recalls are necessary, an efficient system will be in place. Overview of Title II of the Drug Supply Chain Security Act The new regulations apply to all entities involved in the drug supply chain, beginning with the manufacturers and ending with the dispensers. Repackagers and wholesale distributors are included. Some of the new DSCSA provisions that are to be in place by the end of ten years include, but are not limited to: Identification measures: Packages for certain prescription drugs need to have easily readable but unique bar codes. Tracing provisions: All entities in the chain must establish a way that the drugs can be tracked for each step in the process, including who handled the specific drug each time it was transferred from one entity to another in the chain including where and when it was sold. Implement verification measures: Ways must be established to verify the drug is what it claims to be. Within 24 hours of a request from the dispenser to the manufacturer or repackager, the entity must be able to confirm that the product identifier is accurate. Methods to detect and respond to suspected drugs: Standards for identifying potentially dangerous or counterfeit drugs that are not approved must be developed. The suspect drug must be quarantined for further investigation. FDA notification: If a counterfeit, unsafe or unapproved drug is detected, procedures for notification of the FDA must be implemented. Licensing of wholesale distributors: All must report the status of their licenses to the FDA which will be stored in a database accessible by the public. Third party logistics providers must be licensed: Third party logistics providers are those that warehouse, store or ship drugs. This will be the first time they have been required to be licensed. The Pew Charitable Trusts has published a timeline for covered entities to consult. It provides an overview of each regulation, the entity that must comply with the regulation and the date required for the implementation of the specific regulation. https://test-arbour-group.marceldigital.com/blog/2014/drug-supply-chain-security-act-title-ii/ https://test-arbour-group.marceldigital.com/blog/2014/drug-supply-chain-security-act-title-ii/ Tue, 22 July 2014 19:13:00 https://test-arbour-group.marceldigital.com/blog/2014/drug-quality-and-security-act-what-you-need-to-know/ In November of 2013, President Obama signed into law the Drug Quality and Security Act (DQSA). This legislation gives the Food and Drug Administration (FDA) more authority to regulate and monitor compounding pharmacies in an effort to improve oversight and safety of their products. In response to the passage of the DQSA legislation, the FDA has published Title 1, the Compounding Quality Act to enumerate new policies to ensure production of safe, high quality products. Fungal Meningitis Outbreak as the Impetus for the DQSA Questions about the oversight of compounding pharmacies began to arise after an outbreak of fungal meningitis, a rare disease, occurred in 2012. As a result of the outbreak, 64 individuals died and 750 were infected in 20 states. The outbreak was quickly determined to be exposure to contaminated injectable steroidal painkillers that had been compounded in the New England Compound Pharmacy. The outbreak was seen as evidence of insufficient regulation of compounding pharmacies, and U.S. Representative Fred Upton, a Republican from Michigan, introduced DQSA legislation in an attempt to improve the safety of products from compounding pharmacies. These are the objectives of the DQSA. Re-establish section 503 of the Food, Drug, and Cosmetic Act as the governing legislation over compounding pharmacies. Provide clarity regarding which entities are responsible for governing compounding pharmacies. Distinguish and define traditional compounding pharmacies from outsourcing facilities. Address the reality of the changing role of compounding pharmacies. Changing Role of Compounding Pharmacies Addressed in the DQSA Compounding pharmacies traditionally operated as part of an individualized model. They served patients as part of a three-way relationship between patients, physicians, and pharmacists; the role of compounding pharmacies was to provide custom-mixed prescription and non-prescription medications to patients. Over the years, compounding pharmacies have shifted away from this traditional model. Although they still custom-mix medications, they often now also participate in large-scale compounding of sterile drugs. Provisions Regarding Traditional Compounding Pharmacies and Outsourcing Facilities The DQSA distinguishes outsourcing facilities from traditional compounding pharmacies in an effort to clearly explain rules for and oversight of each. Traditional compounding pharmacies remain under the jurisdiction of the states, although the DQSA include provisions to improve communication between states and the FDA. For example, states must report concerns or punitive actions as they occur. Outsourcing facilities are pharmacies that compound sterile drugs in large batches that are not necessarily in direct response to a single patient's prescription. They are monitored and inspected by the FDA, and must pay an annual fee based on their total annual sales values. Twice per year, outsourcing facilities need to report which drugs they are compounding. Inspections and Enforcement The FDA is notoriously underfunded, and has insufficient resources to rigorously inspect all compounding pharmacies or even all outsourcing facilities. The FDA inspects outsourcing facilities using a risk-based schedule, in which the highest-risk facilities are more likely to be examined. Facilities found to be using unsafe practices or manufacturing impure mixtures are subject to fines, and they may also be charged re-inspection fees if they require a return visit from the FDA. Recalls of contaminated or otherwise unusable products can also help keep the public safe when using products from compounding pharmacies. https://test-arbour-group.marceldigital.com/blog/2014/drug-quality-and-security-act-what-you-need-to-know/ https://test-arbour-group.marceldigital.com/blog/2014/drug-quality-and-security-act-what-you-need-to-know/ Thu, 17 July 2014 19:23:00 https://test-arbour-group.marceldigital.com/blog/2014/microsoft-dynamics-updates-2014/ Microsoft Dynamics is a line of software applications that fall into two different categories that are designed to run on computers with the Microsoft Windows operating system. The first category is called enterprise resource planning, which is often referred to as ERP for short. The second category involves customer relationship management , which is often abbreviated as CRM for short. These applications are traditionally delivered not directly from Microsoft to customers but through a collection of reselling partners Customer relationship management is a type of process that allows businesses to connect with their customers in ways they may have never thought possible. It also allows information to be easily shared from one section of a company to another. If the customer service desk at a company is contact by a customer and receives important information about how a product or service can be better developed, the appropriate section of the company can easily access that information through the unified database created by a powerful CRM deployment. As it does with most of its software and various applications, Microsoft has announced a wide variety of different updates to theMicrosoft Dynamics suite to be released in 2014. These product updates and developments will see staggered releases throughout the year. They are designed to expand the core customer relationship management feature set and include new functions like marketing on multiple channels, social listening, enterprise service desk capabilities and more. One of the major Microsoft Dynamics Updates 2014 releases will be two customer relationship management releases throughout the year. A cloud-based update will be released in the second quarter and an on-premise edition will be released in the fourth quarter. Microsoft Social Listening will also be released for Microsoft Dynamics in the second quarter of 2014. It will be a freeupdate for customer relationship management online pro customers of Microsoft Dynamics. Another update to Microsoft Dynamics in the year includes a variety of different improved customer relationship management service tools, which include new entities featuring both entitlements and SLA capabilities. An updated Microsoft Dynamics CRM marketing module will also be released to the public in the second quarter of 2014. One of the most important Microsoft Dynamics 2014 updates is a new, unified service desk, which can completely change the way certain types of power users employ Microsoft Dynamics services. These updates will also come with Parature integration. A newMicrosoft Dynamics customer relationship management license plan has also been announced that will go into effect in 2014, though the company has yet to release all relevant details about what these new license plans entail. Inbuilt customer relationship management calculation fields will also be released to all existing customers in the fourth quarter of the year. The first set of Microsoft Dynamics 2014 updates to be released, however, are being referred to internally by people who work at the company as the "Spring Wave." It will come along with three major updates across various tracks of Microsoft Dynamics including social, marketing and customer relationship management. https://test-arbour-group.marceldigital.com/blog/2014/microsoft-dynamics-updates-2014/ https://test-arbour-group.marceldigital.com/blog/2014/microsoft-dynamics-updates-2014/ Thu, 17 April 2014 20:53:00 https://test-arbour-group.marceldigital.com/blog/2014/what-is-healthcare-cloud-computing/ Healthcare cloud computing has changed the entire healthcare industry in significant ways during the last few years. Before you can understand how cloud computing applies to the healthcare industry, you must first understand what cloud computing is in general. What is Healthcare Cloud Computing? Cloud computing is, simply put, the idea of taking information that would traditionally be stored locally on a computer's hard disk drive and storing it on the Internet. The servers that are used to access these types of information are collectively referred to as "the cloud." For personal computer users, cloud computing might be a way for members of a study group to collaborate on a project from separate locations in real-time using the Internet. It might also be a way to take personal files or folders on your hard drive and store them online, thus making them available to any computer with an Internet connection. For the healthcare industry, this new type of technology has a large number of positive implications. How Does Heathcare Cloud Computing Work? For starters, healthcare cloud computing has completely changed the way that healthcare providers and insurance companies access and share customer records. For example, records can be stored on the Internet and can be accessed remotely by physicians and other healthcare practitioners. If you were ever traveling out of state and got sick, the doctor that you chose to visit would be able to easily access your records if they were stored in a cloud-based database. Healthcare cloud computing also gives doctors the ability to work remotely to increase general productivity. In a traditional healthcare technological deployment, all important computer software necessary for a practice to carry on with day-to-day operations will be stored locally on the computers in a physical office location. If a doctor purchased a program that would benefit the entire practice, it would have to be installed individually on every computer in their office. With healthcare cloud computing, doctors can now take advantage of something called "software as a service" to increase productivity in dramatic ways. Software as a service (SaaS) deployments provide healthcare providers and insurance companies the ability to access important information from mobile devices like smart phones or tablets. The software doesn't have to physically be installed on these machines and instead exists only on the Internet. All a doctor would need to run one of these types of programs would be a device with an active Internet connection and a Web browser. All tech support for software as a service deployments is also handled by the software provider, freeing up resources that would generally go towards IT work to be reallocated to other areas where they will be more useful. Healthcare cloud computing is also an efficient way for healthcare providers to become dramatically more organized. In years past, all customer records and other important documents were physically stored on site at a doctor's office or in some other type of healthcare location. These documents needed to be routinely sorted for easy access and secured to keep up with patient healthcare laws. With healthcare cloud computing, all of these documents can be stored online. Not only are they more secure than ever before thanks to complicated encryption techniques, but they are also protected from events like a fire, robbery or other types of events that could render them lost if they were still being stored in hard copies. The documents are also searchable, which makes them much easier to find when needed. https://test-arbour-group.marceldigital.com/blog/2014/what-is-healthcare-cloud-computing/ https://test-arbour-group.marceldigital.com/blog/2014/what-is-healthcare-cloud-computing/ Tue, 08 April 2014 21:01:00 https://test-arbour-group.marceldigital.com/blog/2014/which-crm-is-right-for-me/ When choosing customer relationship management software for your business or organization, there are always a few key things that you're going to want to keep in mind. Your Clients and Employees First and foremost is the fact that CRM software isn't only meant to be a benefit to your customers, it is also meant to be a benefit to your employees and the business as a whole. Studies have shown that successful CRM deployments make it vastly simpler for your employees to do their jobs, which makes for a much more satisfying experience on a day to day basis. If your employees are satisfied, it will contribute toward increased productivity and potentially business growth. However, you'll get none of these benefits if you don't pick the right system in the first place. Not all CRM deployments are created equal and finding the one right for you requires a lot of thought. Customer and Prospect Databases One of the first things that you need to consider when selecting a customer relationship management solution has to do with the size of your business and, most importantly, the size of your customer and prospect databases. If your business is large with hundreds or even thousands of customers that you're dealing with on a daily basis, you'll obviously need a CRM deployment that can keep up with those demands. Part of the benefit of a CRM deployment has to do with cataloging information about your customers that you can then use to improve both the products and services you offer. If the CRM deployment isn't large enough to meet those demands, you'll be missing out on one of the major benefits of these types of systems in the first place. Your Existing Technology You'll also need to consider the existing technology that is in place in your business when choosing a CRM deployment. One of the major benefits of these types of software applications is the fact that they are inherently flexible. With only a few exceptions, they can be positively integrated into existing software and databases that you are currently using to create one unified ecosystem. However, you'll want to make sure that the CRM solution you're choosing can be integrated before you actually have it installed. You don't want to end up creating yet another wall between departments in the form of two incompatible software solutions which will make it more difficult to pass information to and from departments. Contact Management Options Picking a CRM solution that is right for you also involves considering the contact management options that you need when dealing with customers. Consequently, if you only deal with customers online, then you don't need a system with phone-centric features. Consider the way you run your business and adapt your CRM deployment to those specific needs. https://test-arbour-group.marceldigital.com/blog/2014/which-crm-is-right-for-me/ https://test-arbour-group.marceldigital.com/blog/2014/which-crm-is-right-for-me/ Tue, 01 April 2014 21:07:00 https://test-arbour-group.marceldigital.com/blog/2014/customer-relationship-management-checklist/ The acronym CRM stands for "customer relationship management." As the name suggests, these types of software solutions have a way to positively impact your business or organization in a variety of ways. For starters, they have the potential to connect you directly with your customers in a way you've never experienced before. Secondly, you can use the information obtained from those customers to increase productivity, improve products and services and much more. Successful CRM deployments have several key components in common. One of the first things required… Have a Clear Goal Before the necessary software is installed, you need to sit down with the heads of various departments and figure out why you want to take this admittedly large step forward. Determine if you're trying to make it easier for customers to place orders or if you just want to connect with customers to find out what you can do to make your goods and services offerings more appealing. Having clear goals allows you to develop a more concise strategy for a CRM deployment, which in turn will ensure no part of the system is going to waste or is under-utilized. Find the Right Software Vendor The CRM vendor is the company who will provide both the software product as well as their installation expertise. Not all CRM deployments are created equal, so you need to weigh the pros and cons of each vendor carefully before making a decision. Don't let low cost become the only criteria used. Entering into an ongoing working relationship with a vendor is critical to the initial as well the ongoing success of the CRM initiative. Arguably the most important factor for a successful CRM deployment… The CRM Rollout It is always important to keep things as simple as possible. Even if your business relies heavily on technology on a day-to-day basis, there will still be individuals with different skill sets working with the new software. Someone who grew up around computers and software applications may get used to the new system more quickly than someone who was forced to learn later in life. Keep things as simple as possible and make all aspects of the deployment easy to understand for all types of users. If your roll out makes it easier for your employees to understand the benefits the system offers and the ways in which it will positively impact the business as a whole, they will have a much more satisfying experience with regards to performing their jobs. https://test-arbour-group.marceldigital.com/blog/2014/customer-relationship-management-checklist/ https://test-arbour-group.marceldigital.com/blog/2014/customer-relationship-management-checklist/ Thu, 27 March 2014 21:11:00 https://test-arbour-group.marceldigital.com/blog/2014/benefits-of-customer-relationship-management-crm/ What is Customer Relationship Management (CRM)? CRM is an acronym that stands for "customer relationship management." As its name suggests, it is a type of technology that is making it easier for businesses of all types to engage in and create organic relationships with their customers like never before. However, before you can begin to totally understand the benefits of CRM, you must first understand what customer relationship management actually is. For starters, CRM is a way to allow all groups within a company to focus on customer transactions and activities, regardless of the designated roles of individual departments. Every section of a company including accounting, customer service, sales, management, marketing and more, can all use a centralized customer relationship management solution. CRM allows all groups to more efficiently connect with one another and share information, which ultimately makes it easier to work towards the unified goal of delivering better customer service. In years past, the relevant information obtained from a customer conversation wouldn't necessarily have been easily passed along to other departments where it could be put to good use. By using customer relationship management software, all employees can be well informed with regards to the customers that they're dealing with on a daily basis. Even something as simple as customer complaints can now be passed along instantly to relevant departments, allowing the organization as a whole to use that data to make their products and services better and thus create happier customers. CRM also paves the way for data analytics, which can be used to spot trends that can be of use for identifying changes required to products or business practices. Another one of the major benefits of customer relationship management doesn't actually have anything to do with the customers themselves. Aside from those customers, the second largest group who benefits the most from CRM solutions is the employees within a business. The CRM software solutions in place in an organization can make it easier for employees to do their jobs more efficiently and effectively. Tasks can be delegated to appropriate departments and individuals can be kept up to date with regards to their customers' activities. Employees find it easier than ever before to do their jobs and can experience greatly enhanced job satisfaction. https://test-arbour-group.marceldigital.com/blog/2014/benefits-of-customer-relationship-management-crm/ https://test-arbour-group.marceldigital.com/blog/2014/benefits-of-customer-relationship-management-crm/ Tue, 25 March 2014 21:18:00 https://test-arbour-group.marceldigital.com/blog/2014/top-mistakes-in-saas-implementation/ Before you begin a software as a service (SaaS) transition, you may want to consider some of the commonly made mistakes by companies that are implementing a SaaS application. SaaS is useful, versatile and scalable, but it's still a different type of technology that needs to be approached in a unique way. 1. Not ensuring a reliable Internet connection. Extremely basic items can sometimes be missed simply because they're so obvious. Not all companies take the time to ensure that their Internet connection is stable enough to support their new SaaS applications and find that they encounter issues soon after implementation. Some companies even forget that their employees occasionally need to work offline, leading to disaster. Redundant Internet connections are always ideal for companies that are depending on SaaS. 2. Not running a background check on your SaaS provider. Anyone can be a SaaS host; a server in a basement can technically host SaaS applications. Failure to ensure you have a reputable SaaS provider can be extremely detrimental; you could experience outages, security issues or a case of "disappearing vendor syndrome." Always check reviews before committing to a SaaS provider, and discuss your needs thoroughly. 3. Not following compliance requirements. Many industries are required to operate by strict codes of data compliance. These issues should be thoroughly researched before, not after, switching over to SaaS. Compliance issues often include who will be allowed to access data, how the data will be secured, how long the data will be retained and even how the data will eventually be destroyed. 4. Not anticipating training and employee issues. As any manager knows, employees hate change. Something that seems like a trivial modification to an IT guru or even a business executive may represent a significant amount of frustration or confusion to staff members. Employees should be thoroughly trained and familiar with the SaaS system before it actually goes live; this will ensure that the most significant issues have already been ironed out. Companies should avoid being over-eager to make the transition and instead dedicate as much time as necessary to employee training. 5. Not putting protocols and security standards in place. SaaS applications are extremely accessible — and this can represent some significant security issues. Before the SaaS implementation begins, there should be training on the security protocols that will need to be followed. Mobile device security should be discussed, and all employees should be trained on the proper ways to use and create passwords. If handled correctly, SaaS implementations can lower overhead, increase customer satisfaction and bolster employee productivity. However, if handled incorrectly, a SaaS implementation can turn into a morass of confusion, miscommunication and security issues. A solid transition plan is absolutely essential for those that want to complete the transition without any costly problems. https://test-arbour-group.marceldigital.com/blog/2014/top-mistakes-in-saas-implementation/ https://test-arbour-group.marceldigital.com/blog/2014/top-mistakes-in-saas-implementation/ Wed, 19 February 2014 21:23:00 https://test-arbour-group.marceldigital.com/blog/2014/what-is-21-cfr-part-11/ 21 CFR is a title within the Code of Federal Regulations. Title 21 is reserved for the rules of the United States Food and Drug Administration (FDA). Part 11, specifically, deals with the comparisons between electronic and paper records, and how to ensure that electronic files are kept secure and relevant to be used in conducting the nation's business. Part 11 is divided into three subsections. The first, Subpart A, covers general information for readers such as scope and applicability of the regulation. The second subsection, Subpart B, addresses requirements for electronic records systems. And finally, the third subsection, Subpart C, addresses electronic signatures and how they are stored and processed. Requirements for Electronic Records Electronic records are more convenient and cost-effective when properly stored, protected and handled. Electronic records may be stored on closed systems or open systems. In Subpart B of Part 11, users will find the requirements for the setup, storage and use of electronic systems of records on both closed and open systems. These requirements include validation of records and records keeping systems. The owner and maintainer of a records system must also ensure that only authorized users access these systems. Protection of files and the requirement for written policies governing the system of records and users are also addressed in this subsection. The subsection also covers a requirement that records must be easily retrievable, printable and usable for those parties with a valid need for the information. Requirements for Electronic Signatures Electronic signatures allow documents to be signed without the need to print, sign in wet ink and scan back into a system of records. This cuts down on approval time and cost for materials and supplies. However, signatures must be properly validated and utilized. Subpart C of Part 11 addresses the requirements for these electronic signatures. Electronic signatures must contain several pieces of information. The name of the person signing the document, as well as the date and time the document was signed must be recorded in the signature. In addition, the disposition associated with the signature must be recorded; some dispositions include approval, denial, review or creation of a document. Only authorized individuals may sign documents, and the owner of the system of records is responsible for the documents and the signatures on them. Signed documents must be easily accessible to those with a valid need to use them. Electronically signed documents must also be stored securely so there is no risk of corruption of the signature or the data contained within. The Code of Federal Regulations is very user-friendly and easy to understand. For more information, or to read these regulations in their entirety, users can visit the FDA's website online. The text of 21 CFR Part 11 is located within this site . The regulations are easily organized with clickable links, and allow users to print or bookmark sections for later use. Understanding 21 CFR Part 11 Webinar February 19, 2014 Join us for our "Understanding 21 CFR Part 11″ webinar on February 19th, 2014, when we will discuss in greater detail 21 CFR Part 11, and what you need to know the most. Reserve your spot here . https://test-arbour-group.marceldigital.com/blog/2014/what-is-21-cfr-part-11/ https://test-arbour-group.marceldigital.com/blog/2014/what-is-21-cfr-part-11/ Tue, 04 February 2014 21:29:00 https://test-arbour-group.marceldigital.com/blog/2014/capgemini-and-vmware-cloud-orchestration-partnership/ Software companies Capgemini and  VMware  have announced that they are extending a strategic partnership that will allow them to develop various solutions aimed at making both the management and provisioning of cloud based deployments easier than ever before. The two companies will join together to develop various cloud based solutions that extend  Capgemini ‘s existing service integration. Aggregation and orchestration platforms will also be improved, due in large part to the leveraging of cloud management offerings available from VMware. The two companies have the shared goal to make ITaaS (information technology as a service) offerings easier to achieve for basic consumers than ever before. These new deployments will help improve the way users manage cloud services and allow for better protection of data that has been stored in the cloud, while also improving the overall “time to value” ratio for general cloud adoption purposes. The two companies released a joint statement indicating that the partnership reflects their vision of how information technology companies are evolving in the new era of increased emphasis on cloud based offerings. Cloud based solutions have been completely transforming the technology sector in recent years. One of the most popular examples of cloud based services is cloud storage, which sees information stored on an Internet accessible server instead of on a user’s local hard disk drive. These types of advancements are increasing productivity and decreasing costs across a wide variety of different types of businesses and organizations. Simply put, the partnership will allow businesses and organizations all over the world the ability to simplify the way they manage their existing cloud based services, while improving the overall quality of the services in general. Organizations will be able to quickly create and deliver new services while simultaneously upgrading their existing applications. Capgemini and VMware representatives have said that these types of solutions are aimed at improving both the financial and service level management of cloud based platforms. They will begin to offer a dashboard with real time capabilities that will allow chief financial officers more transparency with regards to how these types of services are used and the current amounts of money being spent on them. . The senior vice president of Capgemini, Raf Howery, commented that both the expansion of the VMware partnership and the introduction of new cloud solutions aimed at business is one integral part of both companies’ cloud orchestration strategy. Enterprises tools are being developed that will help manage the complex IT transformation in ways that are significantly easier than in years past. Additionally, the partnership and the services that arise as a result will allow these types of companies an easier transition into a cloud based world and will afford greater flexibility and increased simplicity with regards to the way these resources are obtained and used. Resources can be deployed across all types of environments including private, legacy, public and even hybrid. Howery expects that businesses will begin to see an immediate impact. https://test-arbour-group.marceldigital.com/blog/2014/capgemini-and-vmware-cloud-orchestration-partnership/ https://test-arbour-group.marceldigital.com/blog/2014/capgemini-and-vmware-cloud-orchestration-partnership/ Fri, 24 January 2014 17:48:00 https://test-arbour-group.marceldigital.com/blog/2013/microsoft-dynamics-for-mobile-apps/ Considering that an estimated 91 percent of all adults own cell phones, and 61 percent of these cell phone owners have smartphones, it is safe to say that many people depend on their phones to help them stay connected. This is even more true for professionals in sales and related industries. These professionals are frequently on the move, such as meeting with various customers and following different leads. Microsoft’s recent release of mobile apps for those using its Dynamics CRM has made using the program immensely more convenient for those on the go. Currently, the apps are compatible with Android phones, Windows phones, and the iPhone. Those on Blackberry can access a browser app. Users can now access their company’s data and customer information wherever they are through their smartphones. The benefits of the Dynamics CRM Microsoft Dynamics CRM  allows companies to easily track their customer data, such as client contact information, product information, and sales information. They can use this information to schedule appointments, update records, attach images to records, send records to other people. Employees can then properly manage the relationships with their customers from within a single program. There are a variety of indicators that can be made into charts for easy, visual readings, while contacts and leads can easily be tracked from the dashboard. People who work in sales and related professionals must be able to track various clients and leads for new contacts at all times. The dashboard makes this immensely easier, so it is a great program for increasing sales numbers. The benefits of the new MS Dynamics CRM Before the new app was released, portions of the program could be accessed through a browser window. While some information could be accessed, there was limits to what could be completed while away from a computer. With the new app, users are now able to use the functions such as creating appointments, selecting values from pick lists, and assign records. Phone calls can also be made from within the app. Within the version designed for the Windows phone, there are even more benefits, such as being able to browse contacts social media activity or pulling up maps of the customer addresses. New versions for Windows tablets offer even more for users, such as the capacity to ‘pin’ important information to the start screen so that it can be easily accessed as soon as the device is turned on. The app now creates a more consistent user experience when users are going from computers to their smartphones. For sales professionals and those in similar professions, MS Dynamics can be an important program. It makes keeping tack of customer information and possible leads substantially easier. Through a dashboard users can track their important company data and product information in addition to scheduling appointments, updating records, adding images, and viewing charts to track progress. A recently released Microsoft Dynamics app allows most smartphone users to access the capabilities through their devices, wherever their job may take them. https://test-arbour-group.marceldigital.com/blog/2013/microsoft-dynamics-for-mobile-apps/ https://test-arbour-group.marceldigital.com/blog/2013/microsoft-dynamics-for-mobile-apps/ Thu, 12 December 2013 18:05:00 https://test-arbour-group.marceldigital.com/blog/2013/microsoft-dynamics-reveals-upgrades/ Microsoft recently hosted the  Microsoft Dynamics  CRM Global Premiere Event in Barcelona, Spain. The event saw over 70,000 attendees. The event showcased several new changes and upgrades to Microsoft Dynamics, with the goal of empowering businesses so they can serve their customers better and increase their customer bases while serving current customers to the best level possible. Microsoft made these latest developments with the help of feedback from actual users, to ensure that the products are targeted to those who will actually use and benefit from them. One of the most well-received announcements was the reveal that 18 new predefined templates will be released with the new update. These templates include options for sports management, government, healthcare, sales and marketing templates, as well as other types of templates. Each of the templates offered is completely customizable to meet the user’s specific needs. Best of all, the templates are being offered free of charge in Microsoft’s CRM Marketplace. This will enable the more than 50,000 users that are subscribed to this feature to have templates that are easily manipulated to provide what is needed when it is needed. In addition, Microsoft is offering subscribers the ability to provide touch-optimized experiences for users of the iPhone, Android and Windows Phones. This functionality is being offered to users without a separate license fee. In addition, a new global pricing structure will offer up to a 40 perfect discount to eligible customers on the purchase Microsoft Office 365 Online professional licenses. This will allow businesses to reach out to more customers at less cost, helping to increase profit margins and maintain success. Microsoft unveiled Microsoft Dynamics AX 2012 R3 in October 2013. This is the latest update of Microsoft’s flagship ERP solution. This update includes many benefits, including new warehousing and transportation managament products, helping to deliver real-time information to assist with successful and timely supply-chain and logistics execution. Microsoft also revealed that Microsoft Dynamics NAV 2013 R2, which was released in October of this year, is now closing in on 100,000 registered users across the globe. This product enables single sign-on capabilities wth Office 365 and Sharepoint Online. It also contains new options for cash management, a new and updated Help Server, and even better adminstrative tools for users and managers. The upgrades and changes are being offered in the hopes that these things will allow businesses to connect with their customers, and turn customers into “fans.” These options will also ensure that businesses can conduct operations in a more timely manner, with less mistakes and problems. The promised upgrades were well received by the sold out crowd of 70,000 people, including powerful global business leaders, and anticipation remains high for the actual release of these products in 2014. https://test-arbour-group.marceldigital.com/blog/2013/microsoft-dynamics-reveals-upgrades/ https://test-arbour-group.marceldigital.com/blog/2013/microsoft-dynamics-reveals-upgrades/ Thu, 21 November 2013 18:10:00 https://test-arbour-group.marceldigital.com/blog/2013/the-fda-and-mobile-medical-apps-who-s-regulated-who-s-not/ With almost 100,000 health related mobile apps (free and fee based) available from popular app stores, patient-consumers have access to information about monitoring vital signs, tracking exercise and caloric intake, and information about drug interaction and contraindications. Physicians and technicians share real-time images from CT scans and monitor heart rhythms to diagnose and treat patients remotely. Emergency room intake staff and triage nurses use medical translation apps to overcome language barriers. As consumers and medical professionals move toward increased dependence on mobile technology to manage health and wellness the Food and Drug Administration (FDA) is stepping up oversight on some medical apps. In a September 23, 2013  press release  the FDA provides information about which applications are subject to strict review and oversight and which will remain informational only. According to the press release, the majority of medical and health related apps available today will not require agency review. The main objective for the agency is to reduce the potential for harm, not limit technological innovation that helps consumers manage their health and medical providers deliver high-quality health care. Medical apps are regulated with the same set of criteria as  medical devices . Manufacturers that develop, build, market and distribute applications advertised and represented as a component or accessory to a medical device or as software that solely operates or transforms a mobile platform into a medical device (i.e. a smart phone or tablet) are the primary entities subject to FDA regulation and recommendations. In simplistic terms, applications that work with medical devices designed to assist physicians make diagnostic and treatment decisions are subject to review and regulations. Apps designed to work with medical devices, such as insulin pumps and imaging technology, are included in the FDA review process. An application that converts a smart phone to an EEG or ECG machine are also subject to the guidelines that regulate all medical devices. The FDA guidelines allow for discretionary enforcement. Consumers will not see any change to the way that apps with low risk factors are developed and marketed. Applications that pose limited potential for harm if they fail, provide inaccurate information or otherwise do not meet expectations will not be reviewed or closely monitored. Pharmacists may see an increase in questions about medical applications from customers. Emerging technology and cloud based medical software are changing the relationship between neighborhood pharmacists and their customers. Conversations that once focused primarily on drug side effects and interactions now include discussions surrounding mobile devices and apps. Insulin dependent diabetics may ask about applications that work with their insulin pumps and glucose meters or applications related to calculating insulin doses and food choices. Pregnant clients may ask about apps that work with perinatal activity and blood pressure monitors. https://test-arbour-group.marceldigital.com/blog/2013/the-fda-and-mobile-medical-apps-who-s-regulated-who-s-not/ https://test-arbour-group.marceldigital.com/blog/2013/the-fda-and-mobile-medical-apps-who-s-regulated-who-s-not/ Thu, 14 November 2013 18:13:00 https://test-arbour-group.marceldigital.com/blog/2013/fda-regulation-slows-the-surge-of-medical-apps-for-mobile-devices/ New rules and regulations will now be requiring the makers of many medical apps to receive FDA approval before offering them to the public.  Any medical app that in effect turns a smartphone into a medical diagnosis tool will now be subject to FDA clearance. The mobile health app market is set to reach  $26 billion  by the year 2017, according to a March 2013 report from Berlin consulting firm Research2Guidance.  There are currently about 97,000 mobile health apps available on the market, tapping into a growing desire among consumers to empower themselves and diagnose their own health ailments. On Sept. 23, the FDA completed regulations related to the level of oversight medical apps will now receive.  The vast majority will not require FDA clearance, however apps that turn a smartphone into a regulated medical device will have to be submitted to the agency for review.  Businesses that don’t comply will risk having their app banned from being sold in the U.S.  This push by the FDA to regulate medical apps is complicated by a gap between the medical regulatory infrastructure and the tech industry. Pursuing the FDA process for approval can take months or even years, and cost tens of thousands of dollars.  Many startups are seeking validation of their projects through crowdfunding campaigns to see if their idea is viable.  If public interest is strong and donations robust, this provides the motivation to proceed with the product and endure the FDA process for approval. Apps that diagnose or treat conditions via smartphones must meet quality standards similar to ultrasound machines, heart stents and other  medical devices .  A 510(k) application is required — the least stringent of device approval paths — with no clinical trials typically required.  However, even just having the regulatory paperwork professionally completed can be costly.  The result?  A great many helpful medical apps may remain unavailable in the U.S.  While some consumers appreciate the measure of vetting and safety that the FDA provides, many businesses are lamenting how difficult it is to get a useful product to a population that loves their smartphones. https://test-arbour-group.marceldigital.com/blog/2013/fda-regulation-slows-the-surge-of-medical-apps-for-mobile-devices/ https://test-arbour-group.marceldigital.com/blog/2013/fda-regulation-slows-the-surge-of-medical-apps-for-mobile-devices/ Thu, 07 November 2013 18:17:00 https://test-arbour-group.marceldigital.com/blog/2013/new-concerns-about-saas-software-as-a-service-and-cloud-security/ The security of SaaS applications on cloud platforms has become  a major concern for many companies . Both SaaS applications and cloud platforms have unique security risks, and using both of them in conjunction can open up a business’s network to security breaches. To counter these breaches, companies need to understand the basics about how these systems work and why they are vulnerable to intrusion. Software as a Service  isn’t a new model of application deployment. Before cloud platforms, SaaS applications were usually hosted by third parties on the internet. This alone creates a security vulnerability because it means that your data is only as secure as the host. In recent years, this host will usually be your cloud platform provider. Since SaaS applications are developed by third parties and accessed through the internet, they can be accessed everywhere. This leaves a  larger point of infiltration for SaaS applications . If the applications are not secured correctly, passwords can be discovered and used to access the network. Many third party applications, especially open source applications, may also not be as secure as they could be. Cloud platforms are vulnerable for different reasons. Anyone can set up a cloud server, and not all cloud server providers are up to date on the most recent security standards. The fact that cloud servers are accessible from everywhere, unlike local networks, opens them up to the possibility of intrusion. Many business owners can protect themselves by only working with cloud providers that have a good reputation, but this isn’t the only security concern with cloud technology. Many businesses are not using adequate encryption or authentication standards. Though SaaS applications on cloud platforms may have some security vulnerabilities, they are still rapidly becoming an industry standard. To ensure safety, companies need to take preemptive action to secure their documents. Working with a reputable cloud host is a good first step. Data needs to be encrypted and the proper authentication and authorization systems need to be implemented. Following this, a company needs to develop security protocols for their employees. Mobile device management may also be useful for those that use mobile devices to access the company cloud network. As with other types of network, a cloud network is often only as secure as the devices and methods used to connect to it. https://test-arbour-group.marceldigital.com/blog/2013/new-concerns-about-saas-software-as-a-service-and-cloud-security/ https://test-arbour-group.marceldigital.com/blog/2013/new-concerns-about-saas-software-as-a-service-and-cloud-security/ Fri, 01 November 2013 18:21:00 https://test-arbour-group.marceldigital.com/blog/2013/what-fda-tracking-requirements-mean-to-medical-apps/ Like contaminated food, malfunctioning  medical equipment  poses a major threat to human health. Due to the risk that improperly-working medical instruments potentially pose to society, the FDA’s Modernization Act (FDAMA) regulates distribution of these devices. To obtain FDA approval, tracking codes are required for some types of medical products, which allow for easier notification and product recall if necessary. Today’s medical “devices” aren’t all handheld equipment, though. Medical mobile apps have become a go-to source for health information for many consumers. Most of these health apps are considered low-risk, and require no FDA clearance. The FDA has pinpointed two distinct app types that they believe pose enough risk to human wellness to regulate: apps designed to “transform a mobile platform into a regulated medical device” and apps “intended to be used as an accessory to a regulated medical device”. Apps that “transform a mobile device,” include that use a sensor connected to a mobile platform to measure any type of essential body signal or component (heart, neurological, blood type). Apps considered accessories are those that connect to existing devices (infusion pumps, X-ray machines, cochlear implants) and have the ability to change settings on those devices. With the popularity of mobile apps, health apps are hitting the market in large numbers, and the FDA process for handling them has been to amend and adjust approval requirements as new technology arises. Final guidance for medical apps was released by the FDA in September 2013, and the basic outcome was that most health apps are in the clear. Health apps that do not have a direct effect on human health, such as calorie counters and weight calculators, are unlikely to ever require any type of regulating. As for those mobile platforms that have the power to alter existing equipment, or to be used in the place of regulated equipment, though, they are under the U.S. Food and Drug Administration’s watchful eyes. https://test-arbour-group.marceldigital.com/blog/2013/what-fda-tracking-requirements-mean-to-medical-apps/ https://test-arbour-group.marceldigital.com/blog/2013/what-fda-tracking-requirements-mean-to-medical-apps/ Thu, 24 October 2013 18:24:00 https://test-arbour-group.marceldigital.com/blog/2013/the-fda-approval-process-suffers-slowdown-due-to-government-shutdown/ On October 1, 2013 the Congress of the United States failed to pass a budget or continuing resolution to fund the government’s ongoing routine operations. As a result, the government furloughed 800,000 employees and stopped or curtailed most government programs. As a result, many unanticipated federal activities ceased or are cut back. For instance, the Food and Drug Administration (FDA) has stopped all food inspections. Other FDA activities have also been temporarily stopped or curtailed. According to the FDA, the effects of the shutdown are far reaching. Following are the major effects of the shutdown:. FDA Operations during Shutdown Emergency work involving the safety of human life or the protection of property; Criminal law enforcement work; and Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA) , Medical Device User Fee Amendments (MDUFA), Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). For a long time the FDA has charged for drugs and medical devices to go through its approval process. It appears that until the government restores full services by ending the shutdown no new applications will be accepted for review. This means that the longer the shutdown lasts the larger and longer the backlog for approvals becomes. However, for drugs and medical devices already in the approval process that have paid their process fees, they will continue along the approval process as planned. Sadly, this also affects people looking forward to joining new clinical trials – it is unclear if new clinical trials can start during the shutdown. The FDA will not be able to accept applications for review of products scheduled for submission in 2014 for which a fee is required until the government funding for 2014 has been resolved. The House of Representatives who forced the shutdown has attempted to make exemptions for select activities of the government. However, there have been no attempts to restore funding to the FDA. https://test-arbour-group.marceldigital.com/blog/2013/the-fda-approval-process-suffers-slowdown-due-to-government-shutdown/ https://test-arbour-group.marceldigital.com/blog/2013/the-fda-approval-process-suffers-slowdown-due-to-government-shutdown/ Wed, 16 October 2013 18:27:00 https://test-arbour-group.marceldigital.com/blog/2013/how-to-select-a-validation-company/ Selecting a third party company to perform validation and software testing can significantly reduce costs while increasing software quality, compared to leveraging internal resources. Having a third party company perform testing allows an organization to redirect its employees toward projects that can positively impact bottom line revenue.   How does a company go about selecting a 3 rd  party validation and testing company? When selecting a validation company, it is important to understand their specific service offerings and past clientele relationships, since most companies have an industry specific niche.    When it comes to validation, a company should have proven in-depth regulatory expertise and global capabilities that will result in a holistic approach to compliance. That third party company must also have the industry expertise with a robust culture of compliance that raises quality levels, reduces costs and has a client tailored approach. Posted by Joe Brundage, Validation Analyst https://test-arbour-group.marceldigital.com/blog/2013/how-to-select-a-validation-company/ https://test-arbour-group.marceldigital.com/blog/2013/how-to-select-a-validation-company/ Mon, 19 August 2013 18:32:00 https://test-arbour-group.marceldigital.com/blog/2013/a-supplier-s-guide-to-servicing-a-life-sciences-company/ Pharmaceutical, medical device and biotechnology companies rely on vendors to fulfill numerous business critical needs.    Whether it is a product, service or IT solution, successful vendors all have a critical component in common: they must anticipate the regulatory risk life sciences companies face and adapt proactively. For example, a medical device company may purchase a specialized electronic chip in order to manufacture their product.    And while the FDA requires a comprehensive quality system be in place for the manufactured product, it holds the medical device company accountable for the finished good, even if the electronic chip malfunctions.    While the electronic chips vendor is not held accountable by regulatory standards, a supplier is required to implement appropriate quality and compliance safeguards throughout its own supply chain.    As an active partner in the supply chain process, the vendor becomes a much more attractive business entity to life sciences companies. In the end, vendors who adopt a life sciences approach will experience both a competitive business advantage and an increase in the quality of their own supply chain. Posted by Joe Brundage, Validation Analyst https://test-arbour-group.marceldigital.com/blog/2013/a-supplier-s-guide-to-servicing-a-life-sciences-company/ https://test-arbour-group.marceldigital.com/blog/2013/a-supplier-s-guide-to-servicing-a-life-sciences-company/ Mon, 05 August 2013 18:34:00 https://test-arbour-group.marceldigital.com/blog/2013/analytics-quality-assurance-s-best-friend/ The concept of analytics has been a buzz worthy topic for the past decade, and for good reason.  Analytics harvests data and information that is being produced by routine business transactions and transforms it into usable information. Analytics have been used to fuel big-picture direction in a company.  Analytics in the realm of a regulatory environment is referred to as Compliance Analytics.  Compliance Analytics can be leveraged to meet FDA reporting requirements. Consequently, risk is also reduced.  Typical areas that life sciences companies utilize Compliance Analytics are as follows: • DEA Suspicious Orders – Automatic identification prior to fulfillment • Return Credit Verification – Monitor and Verify return transactions • Post-Market Surveillance – Reduce reputational harm and potential cost of rework and recalls • Product Discovery – Identify product feasibility prior to launch • Risk Evaluation and Mitigation Strategies (REMS) – enhance evaluation methodologies and reduce risk • Aggregate Spend – Automatic compilation for disclosure compliance • Supplier Performance – Dashboards to optimize spend, efficiency, and compliance • CAPA and Root Cause Investigation – Simplify CAPA identification of discrepancies • Product and Portfolio Management – Visualize aggregate data for investment decisions Compliance analytics can explore unused data and make it useful to the business.    The emerging trend is to use compliance analytics to leverage unused data ultimately to increase compliance measures, decrease regulatory susceptibility, expand quality reach, boost product quality and assure patient safety.   Posted by: Derek Jager, Validation Analyst https://test-arbour-group.marceldigital.com/blog/2013/analytics-quality-assurance-s-best-friend/ https://test-arbour-group.marceldigital.com/blog/2013/analytics-quality-assurance-s-best-friend/ Tue, 16 July 2013 18:42:00 https://test-arbour-group.marceldigital.com/blog/2013/what-does-the-fda-have-to-say-about-validation/ The FDA has outlined the requirement that all life sciences companies validate (Good Manufacturing Practices (GMP)) systems and processes.    While the regulatory requirement is apparent, the FDA has been silent on publishing specific methodologies for achieving compliance.    The FDA allows companies to develop and justify their approach to systems validation as long as the software intended uses are properly documented and tested. A majority of life sciences companies have chosen to utilize the International Society for Pharmaceutical Engineering (ISPE) approach detailed in their publication Good Automated Manufacturing Practices 5 (GAMP 5) as the foundation for their validation efforts.    The FDA has endorsed this risk-based methodology as an acceptable approach as well.   GAMP 5 focuses attention on patient safety, product quality and data integrity for managing risk processes in the supply chain. GAMP 5 has a top-down approach, considering that the risk associated within a system cannot be greater than the risk involved with the processes it supports.    The risk process includes: Step 1 : Perform initial risk assessment to determine system impact   Step 2 : Identify functions with impact on patient safety, product quality and data integrity Step 3 : Perform functional risk assessments and identify controls   Step 4 : Implement and verify appropriate controls Step 5 : Review risks and monitor controls    These five steps provide a high level, yet comprehensive evaluation of risk based on the complexity of software.    While GAMP 5 scrutinizes these steps in many levels, the results of that methodology typically drive the content of the following validation documents: Validation Plan User Requirements/Functional Specifications Traceability Matrix Application Protocols Validation Summary In sum, while the requirements for systems validation is made clear by the FDA, they have not published a particular methodology required to follow.    GAMP 5 has become an approach that has been endorsed by the FDA and has become a commonly referenced standard throughout the life sciences industry. Posted By: Joe Brundage, Validation Analyst https://test-arbour-group.marceldigital.com/blog/2013/what-does-the-fda-have-to-say-about-validation/ https://test-arbour-group.marceldigital.com/blog/2013/what-does-the-fda-have-to-say-about-validation/ Tue, 02 July 2013 18:46:00 https://test-arbour-group.marceldigital.com/blog/2013/what-needs-to-be-validated/ The term validation has a very specific and stringent definition as far as pharmaceutical, medical device and biotech companies are concerned.    At a high-level, the concept of validation ensures a system is operating as intended.    More specific to life sciences companies, validation is a structured process to satisfy a regulatory requirement. Validation deliverables should be considered living documents that provide reliability and assurance that a specific process, method, or system will produce a result that meets a given standard or acceptance criteria.    The thinking behind this approach is to have systems that manufacture, control inventory, or have an impact of the quality of the product, demonstrate that processes are under tight control.    As a result, training records, change control, complaint handling, or anything that may have an affect on cGxP functions (GMP, GCLP, GLP) would fall under the scope of validation. As life sciences companies rely heavily on software to produce products, common examples of information systems that are typically in the realm of validation are below: ERP (Enterprise Resource Planning) MES (Manufacturing Execution System) PLM (Product Lifecycle Management) CRM (Customer Relationship management) LIMS  (Laboratory Information Management System) LMS (Learning Management System) Also, life sciences companies have are diverse in that the use of software varies.    It is possible that 3 rd  party providers also fall under the scope of validation, to possibly include: SaaS  (Software as a Service) IaaS (Infrastructure as a Service)   Data Centers The question of what needs to be validated is hardly concrete.    A comprehensive functional assessment should be performed for all processes that may affect the quality of the product, whether on the manufacturing floor or in the lab.    A regulatory grade functional assessment is the first step and should contain critical rationale into identifying GxP systems.    This step should be taken with expertise and care, as it serves the foundation for auditable documentation. Posted By: Derek Jager, Validation Analyst https://test-arbour-group.marceldigital.com/blog/2013/what-needs-to-be-validated/ https://test-arbour-group.marceldigital.com/blog/2013/what-needs-to-be-validated/ Tue, 18 June 2013 18:51:00 https://test-arbour-group.marceldigital.com/blog/2013/the-proprietary-software-validation-dilemma/ When it comes to  software validation , there is a presumption that home-grown software cannot be validated externally. Organizations tend to operate under the assumption that only those who develop and work with their proprietary software will have the ability to understand its core requirements and intended use.    As a result, the validation effort is directed internally, placing a burden on business users. However, proprietary software is remarkably similar in functionality to off-the-shelf (OTS) or configurable off-the-shelf (COTS) software. The similarities afford an easy transition for an experienced validation professional. The differences encountered mainly occur in modularity and navigation.    These differences are a minor hurdle when a validation professional commits to partnering with a company. Experience with both commercial and proprietary software properly equips a validation professional to learn the software quickly.    The validation is just as thorough with the independent professional, and has many additional benefits that would not be achieved through an internal validation, to include 3 rd  party objectivity and industry best practices. Posted By Colleen Kolba, Validation Analyst https://test-arbour-group.marceldigital.com/blog/2013/the-proprietary-software-validation-dilemma/ https://test-arbour-group.marceldigital.com/blog/2013/the-proprietary-software-validation-dilemma/ Tue, 04 June 2013 18:58:00