Audit Trail Review: what FDA/EMA inspectors look for and how to avoid deviations

Introduction

During an audit, Audit Trail Review (ATR) is one of the elements most closely examined by inspectors.
FDA, EMA and PIC/S look for clear evidence that the company systematically reviews audit trails, understands them, and documents them correctly.
A missing or superficial ATR is a common cause of critical observations.

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In-depth regulatory analysis

The guide highlights that:

• FDA 21 CFR Part 11.10(e) requires complete audit trails for every modification to electronic records.
• EU GMP Annex 11 mandates regular review of audit trails.
• PIC/S PI 041 requires a risk-based approach and a focus on critical data.

Inspectors verify that each audit trail is:

✔️ active
✔️ tamper-proof
✔️ readable
✔️ interpreted in context
✔️ reviewed and signed

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🔎 What inspectors look for

1. Attributability

• No shared accounts
• No improper use of “admin” access
• Every modification must show user, date, time, and reason

2. Data completeness

Inspectors check for:

• reprocessing events
• discarded runs
• missing tests
• unreported data
• 3. Logical consistency of timestamps

Inconsistent timestamps may indicate manipulation.

4. Changes to critical parameters

In manufacturing, every override or setpoint change must be justified.

5. Unmanaged alarms

Alarms that are ignored without notes or deviations are a frequent major issue.

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🛑 How to avoid critical deviations

A. Embed ATR into routine activities

The guide recommends integrating ATR into:

• laboratory second-person review
• batch record review

B. Mandatory justification

Make the “reason for change” field mandatory in all systems.

C. Zero shared-account policy

Shared credentials are considered a serious Data Integrity violation.

D. Exception-based review in manufacturing

Use MES/EBR Exception Reports and validate their effectiveness.

E. QA as Data Integrity supervisor

QA should perform internal audits on CDS, LIMS, MES and SCADA.

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Audit Readiness Section

Documents to provide during an inspection

• formal ATR SOP
• review logs with signatures
• completed ATR templates
• evidence of review (e-signature, comment, filtered report)
• system audit trail mapping
• criticality matrix (critical vs non-critical audit trails)

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Typical error → recommended corrective action

Error: multiple reprocessings without comment
Action: deviation + training + configure mandatory comment.

Error: process parameters changed without justification
Action: investigation + recipe update + QA pre-release verification.

Error: audit trails not reviewed regularly
Action: include ATR in batch records and in data review workflows.

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Conclusion

Demonstrating flawless management of Audit Trail Review is now essential to pass regulatory inspections.
Keep your company audit-ready. Explore the complete guide on GuideGxP.com