Understanding 21 cfr part 11
- 1. Understanding FDA's 21 CFR Part 11 Requirements
- 2. What is 21 CFR Part 11? 21 CFR Part 11: • Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures 21 CFR Part 11 applies: - To all FDA regulated environments - When using computers in the creation, modification, archiving, retrieval or transmission of data or records - To records required by predicate rules – GLP, GCP, GMP – that impact patient safety - To new and old systems
- 3. Purpose of Part 11 • Ensure data is not corrupted or lost • Data is secure • Approvals cannot be repudiated • Changes to data can be traced • Attempts to falsify records are made difficult and can be detected Types of Systems Two types of systems that come under 21 CFR Part 11 – closed and open systems
- 4. Closed and Open Systems What is a Closed system? What is an Open system? A system to which access is controlled by person responsible for electronic records stored on it A system to which access is not controlled by those responsible for the electronic records stored on it
- 5. 21 CFR Part 11 Requirements 21 CFR Part 11 lists the following controls for closed systems: - Validation - Device checks - Operational system checks - Accurate and complete copies - Accurate and steady retrieval - Limited access to systems and data - Authority checks - Electronic audit trail - Training/qualification of personnel - Accountability of signatures - Control over system documentation
- 6. Digital Signatures • Use of digital signatures for open systems Electronic Signatures • Requirements for signed electronic records • Linking records to signatures
- 7. Want to learn more about 21 CFR Part 11, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: • Learning from Recent FDA Warning Letters Related to Part 11 • Understanding and Implementing FDA'S 21 CFR Part 11 • How to Comply with 21 CFR Part 11 Requirements for Electronic Medical Records • Computerized System Validation - A Detailed Insight • 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection • Complying with 21CFR Part 11-Understanding the Role of Predicate Rules