Description

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 application and platform releases. 

Benefits

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