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Senior TrackWise Validation Analyst

Emeryville, CA

Senior TRACKWISE Validation Analyst

Contract role – 6-12++ months

100% Remote – Client located in California (must work Pacific time hours)
 
  • Description:
    • Initial validation of TrackWise performed on 2021 for modules QMS, TMS and DMS + configurations
    • Challenges: RTM not complete and deviation management deficient
 
  • Scope of work for Consultant:
  • Re-validation for the update to the latest released version of TrackWise (Summer 20 à Winter 22)
  • Validation of new configuration changes
 
  • Client will provide:
    • URS updated
    • TWD off the shelf validation and configuration test scripts executed in initial validation
    • Traceability Matrix from initial validation (not complete)
 
  • List of deliverables expected:
•        Configuration Specifications (update existing CS)
•        Validation Plan (update existing VP)
•        OQ/PQ (test scripts): only updates and execution needed
•        Traceability Matrix: very important that all URS are traced, not only the new ones.          Partial RTM available
•        Validation Report
 
Additionally we will also need:
  • Approach of how deviations would be handled
  • List of assumptions of the quote and estimated hours i.e: do you think the processes for PQ/regression testing, are likely to be impacted with/without configurations during the upgrade?
 
 

 
Dawn West
AdeptSource
 
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