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

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Article Summary

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

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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