ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.

Regularly validate electronic systems to ensure accurate data capture and storage.

Implement controls to prevent unauthorized data modification or deletion.

2. Enable Audit Trails

Audit trails are essential for tracking changes and ensuring accountability.

Key Actions:

• Activate audit trail functionality in all electronic record systems.
• Ensure audit trails capture user actions, timestamps, and reasons for changes.
• Review audit trails periodically to identify and address anomalies.

3. Implement Role-Based Access Controls

Restricting access to electronic records ensures data security and minimizes errors.

Key Actions:

• Assign unique login credentials to each user.
• Define access levels based on job roles and responsibilities.
• Review and update user permissions regularly.

4. Backup Records Regularly

Regular backups prevent data loss due to system failures or cyberattacks.

Key Actions:

• Schedule automated backups for all critical electronic records.
• Store backups in secure, off-site locations.
• Test backup and recovery procedures periodically.

5. Train Staff on Electronic Record Management

Educating personnel ensures consistent adherence to GLP standards.

Key Actions:

• Include electronic record management in Good Laboratory Practices training.
• Provide hands-on demonstrations of system functionalities and compliance requirements.
• Organize refresher sessions to address updates or new systems.

6. Maintain Comprehensive Documentation

Accurate documentation supports regulatory compliance and audit readiness.

Key Actions:

• Retain records of all system configurations, validations, and updates.
• Document procedures for data handling, storage, and archiving.
• Store documentation securely and ensure it is easily accessible for audits.

Don’ts for Managing Electronic Records

1. Don’t Share Login Credentials

Shared credentials compromise data security and accountability.

Consequences:

• Lack of traceability for user actions.
• Increased risk of unauthorized access or data breaches.

Solution:

Ensure all users have unique credentials and emphasize the importance of password security.

2. Don’t Disable Audit Trails

Disabling audit trails undermines data integrity and regulatory compliance.

Consequences:

• Inability to track changes or verify data authenticity.
• Non-compliance with GLP standards and regulatory requirements.

Solution:

Ensure audit trails are always enabled and monitor them regularly.

3. Don’t Ignore System Validation

Unvalidated systems may produce inaccurate or unreliable records.

Consequences:

• Errors in data capture, processing, or reporting.
• Non-compliance with GLP and regulatory guidelines.

Solution:

Validate all electronic systems during installation and after significant updates.

4. Don’t Delay Record Backups

Delaying backups increases the risk of data loss in case of system failures.

Consequences:

• Irretrievable loss of critical laboratory data.
• Operational disruptions and potential compliance penalties.

Solution:

Establish and adhere to a regular backup schedule.

5. Don’t Ignore Regulatory Updates

Failure to stay informed about regulatory changes can lead to non-compliance.

Consequences:

• Outdated practices that do not meet current standards.
• Increased risk of regulatory actions or fines.

Solution:

Monitor regulatory updates regularly and revise procedures as needed.

Best Practices for Managing Electronic Records

• Engage QA Teams: Involve quality assurance personnel in monitoring and reviewing electronic records.
• Leverage Technology: Use advanced systems with built-in compliance features to streamline record management.
• Foster a Compliance Culture: Encourage staff to prioritize data integrity and regulatory adherence in their daily activities.

Conclusion

Managing electronic records under GLP requires strict adherence to data integrity principles, regulatory guidelines, and best practices. By following the outlined do’s and avoiding the don’ts, GLP compliance in pharmaceutical laboratories can be maintained effectively. A proactive approach to electronic record management ensures data security, reliability, and readiness for audits and inspections.