Overview: All regulations have strict requirements for electronic raw data and other e-records.
The objective is to ensure accuracy, integrity, authenticity, security and availability of records during the entire life from generation to deletion. While the intent is the same for all regulations only FDA`s 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still leave a lot of room for interpretations.
Reference material for easy implementation: - SOP: Recording of GLP and GMP Raw Data.
- SOP: Retention and Archiving of Electronic Records
- Checklist: FDA Record Retention and Retrieval
Areas Covered in the Session: - FDA Requirements for raw data and meta data
- FDA Inspection and enforcement practices
- Recommendations from industry task forces: GAMP/ISPE guides
- Definition of raw data: original records vs. standard electronic formats, paper print-outs
- Ensure and demonstrate integrity of raw data
- The importance of risk assessment for the management of raw data
- Electronic record maintenance during archiving period
- Software to manage and archive raw data and other electronic records
- Data migration to new systems
- Developing a procedure for consistent raw data management
- Examples from laboratories, offices and manufacturing
Who Will Benefit: - IT managers and system administrators
- QA managers and personnel
- QC and Lab managers
- Validation specialists
- Regulatory affairs
- Training departments
- Documentation department
- Consultants
