FDA 21 CFR Part 11 is a regulation that sets forth the criteria for the use of electronic records and electronic signatures in industries regulated by the U.S. Food and Drug Administration (FDA). It is particularly important in the pharmaceutical, biotechnology, and medical device industries, as it governs the use of electronic systems for managing records and signatures in these regulated environments.
Compliance with 21 CFR Part 11 requires organizations to have certain controls and procedures in place to ensure the integrity, authenticity, and reliability of electronic records and electronic signatures. Checklists are often used as tools to help organizations assess their compliance with these requirements. Below is a checklist of key elements that may be included in an FDA 21 CFR Part 11 Electronic Records (ERES) compliance checklist:
1. User Access Control:
– Are user access privilges defined and documented?
– Is there a system for user authentication (e.g., username and password)?
– Are access levels appropriate for each user’s role?
2. Audit Trail:
– Is there an audit trail that captures changes to electronic records?
– Are audit trail records secure, time-stamped, and accessible for review?
– Can changes to electronic records be traced back to the individual who made them?
3. Electronic Signature:
– Is there a process for creating, storing, and verifying electronic signatures?
– Are electronic signatures unique to individuals?
– Are electronic signatures protected from unauthorized use?
– Have electronic systems and software used for record-keeping been validated?
– Is there a validation plan and documentation in place?
5. Data Integrity:
– Are measures in place to ensure data integrity, including checksums or hashing?
– Are controls in place to prevent data tampering or unauthorized changes?
6. Archiving and Retrieval:
– Is there a process for archiving electronic records in a secure and retrievable manner?
– Can electronic records be easily retrieved and reproduced for inspection by the FDA?
7. Electronic Record Copies:
– Are procedures in place for creating and maintaining copies of electronic records?
– Do these copies maintain the same level of integrity and authenticity as the original records?
8. Training and Documentation:
– Is there a training program in place for personnel on Part 11 requirements?
– Are procedures and documentation related to electronic records and signatures maintained?
9. Security Measures:
– Are there safeguards in place to protect against unauthorized access to electronic records?
– Is there encryption used to protect sensitive data?
10. Periodic Review:
– Is there a process for periodic review and assessment of the electronic record-keeping system for compliance?
11. Quality System:
– Does the organization have a documented quality system in place to support compliance with Part 11?
It’s important to note that the specific requirements and best practices for compliance with FDA 21 CFR Part 11 can vary depending on the organization and the electronic systems in use. Therefore, organizations often tailor their checklists and compliance efforts to their specific needs and circumstances while keeping these general principles in mind. Additionally, consulting with legal and regulatory experts in the field is recommended to ensure full compliance with the regulation.