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      Validation Pack
      • 16 May 2023
      • 1 Minute to read
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      Validation Pack

      • Updated on 16 May 2023
      • 1 Minute to read
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      Article Summary

      With each software release Compliance Path creates a VAL Pack. This documentation package includes:

      DocumentDescription
      Validation Strategy DocumentOutlines the methods by which components of the Tempo validation package were prepared, their purpose, and provides guidance as to their integration into a customer specific configuration
      User Requirements SpecificationA comprehensive foundation for OQ that encompasses all potential Tempo functions a regulated entity might engage
      Risk AssessmentA CSA/GAMP risk assessment of over 1,500 requirements, highlighting key risk considerations and remediation pathways
      Traceability MatrixConfirms 100% traceability from IQ & OQ to the URS and RA, and acts as a quick reference for test-case specific functionality
      Installation QualificationA summary report capturing high-level infrastructure control and monitoring processes in place for the Apprentice Cloud
      Operational QualificationRisk-based functional testing of Tempo, reflecting all requirements identified and risk assessed
      IOQ Summary ReportValidation summary report that details IQ and OQ activities
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