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  2. Automated Validation Manager

Automated Validation Manager

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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
Related Applications
Serial Number Manager
Serial Number Exchange
Serialized Operations Manager
Master Data Exchange

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Related Content

AVM Walkthrough: How AVM Automates Validation Testing

See how AVM executes automated testing for continuous validation across your entire solution by watching this 20-minute webinar.

Specialty Pharma Automates Validation to Ensure Compliant Launch

When a leading provider of CNS (central nervous system) drugs decided to launch its first independently commercialized product in the U.S., it selected the TraceLink Life Sciences Cloud as its serialization platform, and chose TraceLink’s Automated Validation Manager (AVM) to optimize its software testing and help address frequent updates in the regulatory landscape.

AVM Helps Virtual Manufacturer Automate Software Validation Across Diverse Supply Chain

Read how a leading biopharmaceutical manufacturer turned to TraceLink’s Automated Validation Manager to help manage software compliance.

 

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