Implementing the New FDA Data Integrity Guide
In the last couple of years FDA has increasingly observed CGMP violations involving data integrity lapses during CGMP inspections. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. For better understanding FDA's data integrity expectations the agency has published a draft guidance answering 18 questions related to data integrity for cGMP compliance.
The guidance also. clarifies the following terms as they relate to CGMP records: data integrity, metadata, audit trail, "static" and "dynamic" record formats, backup, and "systems" in "computer or related systems". Attendees of this seminar will be able to fully understand and implement the new FDA guidance and avoid regulatory actions related to data integrity
Areas Covered in the Session:
- Understand definitions and examples of data, raw data and met data
- Definition and examples of static and dynamic record formats
- The meaning of ALCOA and ALCOA+ components
- Review of electronic audit trail review: who, what, when and how
- Examples for 'computer or related systems' as defined by FDA
- What to do if the 'record' owner is also the system administrator?
- Controlling blank forms by the quality unit
- Procedure for using electronic records as a substitute for paper records
- Procedure for using paper records as a substitute for electronic records
- Procedure for using electronic signatures instead of handwritten signatures
- Definition and examples for system evaluation samples, system suitability standards and actual samples
- Handling internal integrity related tips, e.g., on data falsification
- Handling data integrity problems identified during internal audits and FDA inspections
For easy implementation, Attendees will receive:
- SOP: Integrity and Security of Electronic Data
- Checklist: Security and Integrity of Electronic Data
- Checklist: 21 CFR Part 11
Who Will Benefit:
- Everybody who creates, reviews and approves regulated electronic records
- Documentation Professionals
- QA/QC Managers and Personnel
- IT Professionals
- Analysts and Lab Managers
- Validation Specialists
- Consultants