Arbour Group continually monitors new regulations and BPCS updates to ensure compliance and continuity for your business, allowing your team to focus on critical business activities rather than spending time producing validation documents.
As a global leader specializing in providing a full range of services related to regulatory software compliance, Arbour Group understands the mission-critical importance of having a fully compliant environment. Life sciences companies use software solutions throughout their organization to manufacture product, control processes and generate reports related to regulated activities. These software solutions, whether on premise or in the cloud, are part of the regulatory environment. Consequently, the software developers must be managed to ensure compliance with applicable regulatory standards to include FDA 21 CFR Part 11.
Why audit your software developers and their processes?
Audits provide tangible feedback as to the software developer’s compliance profile. We help life sciences companies verify the quality standards of software developers by conducting audits as part of a vendor management process.
The audit of a software developer will include an examination of:
- Quality Systems & Procedures
- Software Development Life Cycle (SDLC) Processes/Practices
- Electronic Records/Electronic Signatures
- Security, Access Controls & Audit Trail
- Release Management
- Change Management
- Operational Controls
- Validation Deliverables
- Training Records
Arbour Group continually monitors new regulations and ARISg updates to ensure compliance and continuity for your business, allowing your team to focus on critical business activities rather than spending time producing validation documents.
Arbour Group continually monitors new regulations and MS Dynamics updates to ensure compliance and continuity for your business, allowing your team to focus on critical business activities rather than spending time producing validation documents.