TraceLink’s Automated Validation Manager (AVM) is an automated validation service for end users, providing a set of test cases for execution and a set of corresponding validation documents generated to support quality and validation requirements related to TraceLink Life Sciences Cloud platform releases.
AVM is based on a robust test methodology and set of validation documents to support a company’s computer system validation requirements, designed to help companies maintain validation and quality processes in today's increasingly diverse and changing supply chain environment.
- Meet internal and GMP validation requirements while keeping pace with industry compliance change and emerging business needs
- Evolving regulations
- New and changing data and technology standards
- Diversifying supply and trade partner requirements
- Reduce internal time and costs to validate initial solution deployment and future upgrades
- Eliminate the need to manually write and execute validation scripts against new functionality
- Leverage the TraceLink platform and network tenancy to benefit from the full suite of automated tests continually executed against platform and application releases
- Automate functional testing of TraceLink’s user interface and file transactions across standard TraceLink maps
- Re-direct scarce validation resources to internal needs while maintaining a thoroughly validated TraceLink infrastructure
- Minimize risk of non-compliance expanding, simplifying, and automating validation processes
- Control and confidently predict future validation costs through a subscription model
Capabilities and Features
TraceLink AVM supports customers in minimizing both the in-house and outsourcing burdens of validation by automating certain tests and confirming that current TraceLink software and platform capabilities perform as intended, resulting in a fully executed, paperless package designed for compliance with GxP compliance standards such as GAMP 5.
- Validation Plan. Defines the scope of the validation and governs the execution of the validation process
- User Requirements Specification. Specifications include requirement description, type, priority, status and risk requirements metrics based on functionality, priority, and risk
- Functional Risk Assessment. Document that outlines the risk associated with the functionality based on its business impact coupled with a risk assessment that is performed with each release to determine potential business impact
- Test Cases and Results. Detailed test cases for specific applications and use cases, with results of tests produced based on automated and manual testing
- Traceability Matrix. View all requirements, their associated tests, and the results
- Testing Certificates. Installation Qualification (IQ) and Operational Qualification (OQ) certificates of the installation and operational quality assurance processes executed in the validation environment
- Validation Release Summary Report. Comprehensive report including details of all requirements, test status, and test results
- Release Preview. AVM status, corresponding test case IDs and Comments cross-referenced in release documents to facilitate impact analysis and promote continuous validation