What is Compliance
FDA requirements applied to information systems are defined in the Code of Federal Regulation (CFR),
chapter 21, part 11. Data management has to comply with the rules intended to ensure data sustainability, authenticity, integrity and traceability.
AetiolTM-EDC provides a fully featured, 21 CFR part 11 compliant EDC solution, giving both investigators and monitors a powerful yet easy-to-use environment for data entry and monitoring. AetiolTM-EDC supports all the steps of the clinical trial process from the translation of the clinical trial protocol to the consolidation of all collected trial data, ready for reporting and analysis. It is available online and can be securely accessed from anywhere by authorized users.
Why 21 CFR Part 11?
21 CFR Part 11 has established the US FDA's regulations under which
electronic records and electronic signatures can be considered upright, reliable, and equivalent to paper records.
Electronic records equivalent with paper records
- Storage, retrieval and copying in full retention period.
- Submitting to FDA.
Protection of electronic records
- Security (physical and logical).
- Validation
- Audit trail (who did what, when including reason wherever required.).
Permission to use of electronic signature.
- Equivalent with hand written signatures.
- Name Date and Purpose.
- Linking of signature to record.
- Unique for an Individual.
- Comprehensive report system.
In terms of electronic records, 21CFR Part 11 sets 2 Main requirements
- Securing authentication of individuals.
- Audit trails in place to trace all records in the system.