1. Establish a policy for electronic records and signatures:
This means developing a written policy specifying how electronic records and signatures will be used in your business. The policy should include specific requirements for authentication, verification, and audit trail creation.
2. Verify that your software can create tamper-evident electronic records:
This means verifying that your software can create records that are difficult to alter or modify without being detected. Tamper evident records can help ensure the integrity of your data and protect you from fraud or tampering.
3. Verify that your software can generate unique identifiers for each user:
This means verifying that your software can create unique identifiers for each user, which helps ensure data integrity and prevents unauthorized access to data.
4. Verify that your software can authenticate users:
This means verifying that your software can verify the identity of each user before allowing them access to sensitive data. Authentication methods may include usernames and passwords, PINs, or biometric scans.
5. Train employees on how to use the software correctly:
Training employees on how to use the software correctly is essential for ensuring compliance with 21 CFR Part 11 regulations. Employees must be taught how to use the software properly and be aware of the dangers of tampering with electronic records.
6. Create audit trails to track changes made to electronic records:
Creating audit trails is important for tracking changes made to electronic records and verifying that they were made by authorized users. Audit trails can also help you troubleshoot problems with your system and identify any potential security breaches.
7. Store electronic records in a secure location:
Storing electronic records in a secure location is essential for protecting them from unauthorized access or alteration. The location should be protected by strong security measures such as password protection and encryption.
8. Use strong passwords and encryption methods to protect data integrity:
Using strong passwords and encryption methods is important for preventing unauthorized access to data and ensuring the integrity of your information. Passwords should be difficult to guess and encryption methods should be robust enough to prevent tampering or hacking.
9. Test your system regularly for compliance with 21 CFR Part 11:
Testing your system regularly is essential for ensuring that it meets all the requirements of 21 CFR Part 11. Testing should be done on a regular basis, and any changes to the system should be tested before being implemented.