PIC/S PI 041-1 Draft Guidance: Good Practices for Data Management and Integrity, 11/18
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In November, 2018, PIC/S participating authorities published this draft document of data management and integrity guidelines for manufacturers and distributors of APIs and medicinal products.
This draft guidance contains clarifications and expectations for the following topics:
- Data Governance
- Data Life Cycle
- Data Risk Management
- Management Review and Resource Allocation
- Data Integrity Issues
- Record Retention, Protection, Archival
- Data Integrity for Out-Sourced Functions
The draft guidance also provides recommendations regarding:
- Qualification and Validation of Computerized Systems
- Validation Master Plans
- Periodic Validation Review of Computerized Systems
- Data Transfers and Migrations
- System Security
- Electronic Signatures
- Audit Trail Reviews
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