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Challenge

Within a major pharmaceutical company, support the Data Integrity (DI) is a global problem and currently a major concern with GDA and European Regulatory Agencies

  • Support the R&D Data Integrity program by providing Quality Assurance (QA) oversight on practical activities related to Computerized Systems Validation (CSV)
  • Perfrom QA oversight on assessments of computerized systems in scope in order to ensure that the assessments are conducted

Our Approach

Support the R&D Data Integrity program by providing QA oversight on practical activities related to Computerized Systems Validation (CSV). This includes:

  • Reviewing the documentation provided by the Data Integrity team or users
  • Reviewing the processes analysis performed (e.g. Safety, Immunology and TRD processes and systems)
  • Reviewing/tracking CAPAs and associated tasks
  • Reviewing/approval of the established systems inventories
  • Reviewing proactively the Risk Based Approaches to be defined and applied
  • Providing QA oversight on Data Privacy and Information Protection activities and deliverables
  • Reviewing  the new/updated Written Standards (e.g. Standard Operating Procedure (SOP) on  Audit Trails review)

Results

  • Ensure that the assessments are conducted taking into account latest industry and health authority guidances
  • Give QA oversight on the activities performed and deliverables produced by the CSV lab operations remediation team
  • Provide QA oversight on the data and system landscapes mapping activities, performed by the data architects 
  • Support the implementation of Data Integrity controls.