Earlier this year, the FDA published draft guidance on Data Integrity and Compliance for GMP. And now PIC/S has published a new, draft document Good Practices for Data Management and Integrity to guide manufacturers of medicinal products in complying with GMP and GDP requirements.
As a member of PIC/S, the US FDA participated in the development of this guidance. The draft PIC/S guidance contains the participating inspecting agencies’ expectations regarding subjects such as record retention, protection, and archival; ensuring data integrity for out-sourced functions; system validation and periodic validation review; data migrations; the use of electronic signatures; best practices for audit trail reviews; and, how to address data integrity issues.
What’s in the draft guidance:
Clarifications and Expectations
- 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
PIC/S Recommendations
The draft guidance also provides recommendations regarding: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
Do you need more help implementing these recommendations in your organization? Talk to our CSV experts about how you can update your practices for compliance.