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November 18, 2024

Understanding 21 CFR Part 11 Compliance

Ensuring compliance with 21 CFR Part 11 helps maintain the integrity, reliability, and security of electronic records and signatures, which are critical for regulatory approval and inspection readiness. When evaluating your electronic systems for 21 CFR Part 11 compliance, the focus should be on assessing the systems and processes related to electronic records and electronic signatures to ensure they meet regulatory requirements.

Here is a checklist of key areas to review:

1.     System Validation

1. Validation Documentation: Ensure the system used for managing electronic records and signatures has been validated.
2. Validation Protocols: Review protocols for testing system functionality, security, and performance.
3. Change Control: Verify that any changes to the system are validated and documented.

 

2.     Security Controls

1. Access Control: Confirm that the system restricts access to authorized personnel only.
2. Unique User IDs: Ensure every user has a unique ID and password to access the system.
3. Password Management: Check password strength policies (e.g., complexity, expiration, reuse restrictions).
4. Account Lockout: Verify account lockout policies for multiple failed login attempts.

 

3.     Audit Trails

1. Audit Trail Activation: Ensure audit trails are enabled for all critical actions.
2. Capturing Key Information: Audit trails should capture the date, time, user ID, and details of the action performed.
3. Tamper-Proof: Verify that audit trails cannot be altered or deleted by users.
4. Review and Reporting: Ensure audit trails are reviewed periodically and can be exported for analysis.

 

4.     Electronic Signatures

1. Signature Uniqueness: Confirm electronic signatures are unique to each individual.
2. Binding Signatures: Verify that signatures are permanently linked to their respective records.
3. Identity Verification: Review processes to ensure the identity of the signatory is verified.
4. Signature Manifestation: Confirm that electronic signatures include the printed name of the signer, the date and time, and the purpose of the signature.

 

5.     Record Integrity

1. Data Integrity: Ensure records cannot be modified or deleted without proper authorization and documentation.
2. Backup and Recovery: Verify the existence of robust backup and recovery processes to prevent data loss.
3. Readability and Accessibility: Confirm that records remain readable, retrievable, and accessible throughout their retention period.

 

6.     System Security

1. System Integrity: Assess measures to prevent unauthorized access, such as firewalls, antivirus software, and encryption.
2. Incident Management: Review policies for handling security breaches or data corruption.
3. Physical Security: Check physical controls for servers, workstations, and other hardware hosting the electronic systems.

 

7.     Training and Competency

1. Personnel Training: Verify that all personnel involved in managing electronic records and signatures are trained in Part 11 requirements.
2. Training Records: Ensure training records are complete, up to date, and compliant with GCP and regulatory standards.

 

8.     Documentation

1. SOPs: Review standard operating procedures (SOPs) for system use, electronic records management, and signature processes.
2. Documentation of Controls: Ensure all system controls, including audit trails and access restrictions, are documented.
3. Record Retention: Verify that electronic records are retained for the required duration and comply with regulatory requirements.

 

9.     Risk Management

1. Risk Assessment: Confirm that a risk assessment has been conducted to identify and mitigate risks associated with electronic systems.
2. Periodic Reviews: Check for regular reviews and revalidation of systems to ensure ongoing compliance.

 

10. Third-Party Vendors

1. Vendor Qualification: Ensure third-party vendors providing software or services are qualified and comply with Part 11 requirements.
2. Service Agreements: Review agreements with vendors to confirm responsibilities for compliance, data security, and system maintenance.

 

11. Change Management

1. Change Control Documentation: Verify that all system changes are documented, validated, and approved.
2. Impact Assessment: Check whether changes are evaluated for their potential impact on Part 11 compliance.

 

12. Regulatory Submission and Inspection Readiness

1. Submission Processes: Ensure records generated by the system are compliant for use in regulatory submissions.
2. Inspection Support: Confirm the system and records are ready for audits or inspections by regulatory authorities.

 

13. Legacy Systems

1. Assessment of Legacy Systems: Ensure older systems are evaluated for Part 11 compliance or have documented justifications and compensating controls for non-compliance.
2. Data Migration: Verify the integrity and traceability of data migrated from legacy systems.

 

14. Common Pitfalls to Avoid

1. Purchased validations from a vendor, typically do not include a 21 CFR Compliance Assessment. You will have to perform this activity yourself or contact us at info@gxpsolutions-pharma.com.
2. Make sure the purchased validation complies with your companies’ policies and procedures.
3. Using systems that lack proper validation or security controls.
4. Poor management of passwords or shared user accounts.
5. Inadequate or incomplete audit trails.
6. Failing to periodically review and update SOPs, training, and validation protocols.
7. Neglecting vendor compliance responsibilities.

 

 

For More Information Visit:

https://gxpsolutions-pharma.com/newsletter-2/

 

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