Achieving Part 11 compliance isn’t a one-time process. If your business stores electronic records and signatures, it needs to adopt best practices and routinely audit and inspect its processes to make sure they align with the FDA’s expectations.
Keep in mind that while Part 11 is several decades old, the FDA continues to evolve its thinking regarding the policy and its application to electronic records, systems, and signatures. For further guidance, a recent FDA webinar focuses on their evolving uses in clinical investigations.
It’s also important to work with legal advisors, product managers, and other internal stakeholders when planning for Part 11 compliance. As you go through the process, use the following checklists to smooth the road to compliance.
Electronic signatures
To achieve compliance, you’ll need to have measures in place that ensure the integrity and reliability of your electronic signatures.
- Outline specific requirements for electronic signatures.
- Use controls to ensure electronic signatures correlate with electronic records.
- Install mechanisms to ensure the integrity of your electronic signatures.
Electronic records management
When storing electronic records, take active measures to ensure documents remain secure and accessible throughout their entire lifecycle.
- Create policies and procedures for managing electronic records.
- Set strong access controls to prevent unauthorized users from modifying records.
- Maintain computer-generated audit trails at all times.
Computer system validation
The computer system that you use to manage and store electronic records and signatures must be fully optimized and contain thorough compliance documentation.
- Determine the regulatory requirements for your specific computer system.
- Work with reputable vendors offering Part 11-compliant services. Vendors must be able to provide documentation and demonstrate compliance.
- Create a system change control process to manage changes to your computer system.
Security measures and access control
Electronic records should contain robust security features and strong access controls to prevent tampering.
- Set comprehensive access control policies to determine who can access records.
- Create processes for user account creation and modification.
- Use encryption mechanisms to protect data at rest and in transit.
Periodic review and system maintenance
It’s critical to periodically review and maintain your electronic records and management systems to evaluate their compliance with Part 11.
- Review your processes, controls, and documentation to ensure they align with the FDA’s requirements.
- Check for data integrity to verify the accuracy of your electronic records.
- Monitor your electronic records and review audit trails to identify security incidents or changes.
Documentation and recordkeeping
Thorough recordkeeping is necessary to ensure that electronic records remain traceable and accessible.
- Use a document management system to create, modify, and archive electronic records.
- Create policies to manage electronic document retention.
- Develop procedures that outline specific processes for managing electronic records.
Preparing for audits and inspections
Companies must be prepared to respond to FDA requests for Part 11 audits and inspections.
- Review the regulation with your legal team to ensure you understand what your business needs in order to achieve compliance.
- Create thorough documentation and verify that it aligns with the FDA’s standards.
- Perform regular internal audits to identify vulnerabilities and address areas that need improvement.
