FDA 21 CFR Part 11 sets forth regulations regarding electronic records and electronic signatures in industries regulated by the FDA, including pharmaceuticals, medical devices, biologics, and food and beverages. Compliance with 21 CFR Part 11 is particularly important for organizations that maintain electronic records and use electronic signatures in their operations.
Here's an overview of FDA 21 CFR Part 11 compliance:
- Scope: 21 CFR Part 11 applies to records in electronic format that are created, modified, maintained, archived, retrieved, or transmitted under any FDA regulation. This includes records related to clinical trials, manufacturing, laboratory testing, and other regulated activities.
- Requirements: The regulation outlines specific requirements for electronic records and electronic signatures, including: Validation of electronic systems to ensure accuracy, reliability, and consistency of electronic records. Employing secure, computer-generated and time-stamped audit trails for recording activities related to the creation, modification or deletion of electronic records. Use of electronic signatures that are unique, attributable to the individual, and protected from unauthorized use. Controls to ensure the integrity of electronic records throughout their lifecycle, including protection against unauthorized access, alteration, or deletion.
- Validation: Organizations subject to 21 CFR Part 11 must validate their electronic systems to demonstrate that they can meet the requirements of the regulation. This typically involves a comprehensive validation process that includes testing, documentation, and verification of system functionality and performance.
- Security Controls: Compliance with 21 CFR Part 11 requires implementation of appropriate security controls to safeguard electronic records and electronic signatures from unauthorized access, tampering, or destruction. This may include access controls, encryption, authentication mechanisms, and physical security measures.
- Audit Trails: Electronic systems subject to 21 CFR Part 11 must maintain secure, computer-generated audit trails that capture a record of all actions taken with respect to electronic records, including who performed the action, when it was performed, and the nature of action.
- Documentation: Organizations must maintain accurate and complete documentation related to their compliance with 21 CFR Part 11, including validation documentation, policies, procedures, and records of electronic signatures and electronic records.
Non-compliance with 21 CFR Part 11 can result in regulatory enforcement actions, including warning letters, fines, and product recalls. Therefore, organizations subject to the regulation must ensure that their electronic systems and processes are designed, implemented, and maintained in accordance with the requirements of 21 CFR Part 11.
