Life sciences & chemicals
Support a R&D Data Integrity program by providing QA oversight
Context
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
Objectives
- Support the R&D Data Integrity program by providing Quality Assurance (QA) oversight on practical activities related to Computerized Systems Validation (CSV)
- Perform 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 the 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
