Maintain Access Logs for Electronic GMP Systems to Ensure Accountability

Keep Detailed Access Logs for Electronic GMP Systems

Remember: Every login, action, or change in GMP electronic systems must be logged and traceable to ensure accountability.

Why This Matters in GMP

Electronic systems are integral to data collection, analysis, and product release decisions in pharmaceutical manufacturing. Without access logs, it is impossible to determine who accessed, modified, or deleted data. This violates the principles of data integrity and undermines trust in electronic records. Access logs serve as a digital footprint that allows forensic review of system activities during investigations or audits. Inadequate access control has been linked to fraud, data manipulation, and security breaches. Maintaining robust access logs promotes a culture of accountability, ensures traceability, and deters unauthorized system activity — all essential for regulatory trust and compliance.

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Regulatory and Compliance Implications

FDA 21 CFR Part 11 requires electronic systems to maintain secure, computer-generated audit trails that record all user activity. EU GMP Annex 11 and WHO GMP demand access logs to be retained, reviewed, and protected against tampering. Schedule M also requires system access control with role-based rights and traceability. Auditors often examine access logs to detect data backdating, unauthorized s, or excessive admin privileges. Inconsistent or missing logs are grounds for serious regulatory action, especially in facilities handling critical batch release or lab data. Well-maintained logs reflect a mature, compliant electronic system.

Implementation Best Practices

Configure systems to record logins, logouts, role changes, and data entries or deletions.
Ensure that access logs are backed up, time-stamped, and stored in protected formats.
Limit admin rights and establish user role hierarchies to prevent misuse.
Review access logs periodically and document any anomalies or corrective actions taken.
Include access log review in QA audits and computerized system validations.

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Regulatory References

FDA 21 CFR Part 11 – Electronic Records and Signatures
EU GMP Annex 11 – Computerized Systems
WHO GMP – Computer Systems and Data Security
Schedule M – Electronic Record Maintenance