Redefining GxP Processes with Automated Validation Manager
New and emerging compliance requirements for the pharmaceutical supply chain are in a constant state of change. Laws and standards are evolving. Trade partners place data exchange demands on others. Ongoing business initiatives impact software and infrastructure updates. Even the smallest modification to your track and trace ecosystem—and the need to validate software when you make changes—can impact your ability to stay 100% compliant and ensure drug supply to all the markets you serve.
TraceLink Automated Validation Manager (AVM) automates the entire validation life cycle of the TraceLink Life Sciences Cloud, with automatic testing and confirmation to ensure all current TraceLink software capabilities meet GxP compliance in accordance with industry standards such as GAMP 5.
Customers using the Life Sciences Cloud already benefit from the only network-tenant solution that enables them to quickly adapt to rapid change in today’s continuously evolving regulatory environment. Now, when TraceLink provides timely software updates that maintain your compliance, TraceLink Automated Validation Manager gives you the confidence to know that all current TraceLink software capabilities are performing as intended.
With TraceLink AVM, there's no longer a need for manual, labor-intensive, paper-based validation procedures. The only action you need to take is to log in and access your validation certificates.
Every TraceLink AVM customer benefits from:
- A functional risk assessment – highlighting the GxP, business, and functional impact of each TraceLink software release.
- A validation plan – outlining the approach and methodology, related procedures, and expected deliverables.
- A user requirements specification document – detailing the TraceLink Life Sciences Cloud functionality, including requirement priority, type, and risk profile.
- Installation Qualification (IQ) and Operational Qualification (OQ) certificates – authenticating the installation and operational quality assurance processes executed in the validation environment.
- Comprehensive Performance Qualification (PQ) – including hundreds of test scripts and their results.
- A traceability matrix – allowing users to view all requirements linked to their corresponding tests and their results.
- A final Certificate of Release – confirming the successful validation of the Life Sciences Cloud against GxP requirements for computer systems validation.
- 24/7 real-time access to all validation resources and test results – using an interactive, searchable web-based portal.