September 21, 2025

In the pharma industry, Good Manufacturing Practices (GMP) are the backbone of product quality and regulatory compliance. One key part of GMP is the audit trail review, which has now become a big focus for regulators.

As we step into 2025, agencies like the FDA, EMA, and MHRA are putting more pressure on companies to show strong systems for data integrity, real-time reviews, and clear records. This means companies must upgrade how they manage audit trials to stay compliant, pass inspections, and protect product quality.

What Is an Audit Trail in GMP?

An audit trail is an electronic log that records every action related to data—such as who created it, changed it, or deleted it. In GMP, this applies to critical information in manufacturing, testing, batch records, and product release. Think of audit trails as digital fingerprints that prove your data is complete, secure, and trustworthy. Regulators use them as key evidence during inspections.

What’s New in 2025?

Health authorities now expect more structured, risk-based reviews of audit trails. Here are the top requirements:

  1. Risk-Based Reviews – Focus on the most critical data, such as lab results and batch records, instead of checking every single log.
  2. Timely Reviews – Build audit trail reviews into SOPs and QMS with clear timelines. Late reviews are flagged as compliance risks.
  3. Clear Roles – Assign trained staff who understand both the data and GMP context.
  4. Proper Documentation – Keep clear evidence of reviews with reviewer notes, logs, and CAPA where needed.
  5. Integration into QMS – Audit trail review must be part of the full Quality Management System (QMS), not just an IT check.

Common Problems Seen by Regulators

Many companies still make the same mistakes, such as:

  • Reviewing audit trails only during investigations
  • Poor or missing documentation
  • Ignoring important details like timestamps and user IDs
  • Relying on old systems that don’t meet ALCOA+ standards

(ALCOA+ = Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available – a global data integrity standard.)

Best Practices for 2025

To stay compliant in 2025, companies should:

  • Use Risk-Based Schedules – Apply tools like ICH Q9 to set review frequency.
  • Train Reviewers – Make sure staff can read and understand audit trails in the GMP context.
  • Automate Reviews – Use digital tools to flag unusual activity and reduce manual work.
  • Check System Compliance – Ensure systems meet 21 CFR Part 11 and Annex 11.
  • Link to CAPA – All findings should connect directly to corrective and preventive actions.

How Maven Regulatory Solutions Supports You

At Maven Regulatory Solutions, we help pharma and life sciences companies meet global audit trail expectations with services like:

  • GxP compliance audits and mock inspection support
  • Computerized System Validation (CSV) planning and execution
  • SOP writing and QMS integration
  • Regulatory intelligence on FDA, EMA, MHRA requirements
  • Digital QMS solutions for real-time audit trail monitoring

With Maven, you can build a compliant, efficient, and inspection-ready audit trail process.

Conclusion

In 2025, audit trail review is not just a checklist—it’s a must-have compliance practice. Regulators will expect companies to show strong, risk-based, and well-documented reviews as part of their QMS. By following best practices and working with experts like Maven Regulatory Solutions, companies can ensure data integrity, GMP compliance, and smooth regulatory inspections.