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Audit Trail

What is Audit Trail?

A chronological record of system activities that enables the reconstruction and examination of events. Essential for forensic analysis and regulatory compliance.

Audit

Related terms

SIEM (Security Information and Event Management)

Frameworks that govern audit trail

ISO 27001:2022View framework →

What the standards actually require on audit trail

Requirements naming audit trail across 6 standards, quoted from the control text.

RBI Cybersecurity Framework for Banks6 controls

The bank regularly monitors audit trails and system logs to detect, understand or recover from unauthorised activity or attack.

rbi-cybersecurity-framework-for-banks::96 · Para 96: regular monitoring of audit trails and logs →
MTCS (Singapore)4 controls

Each access to the network and to system components leaves a captured, protected audit trail. Level 1 (a and b): each audit trail entry records user identification, event type, date and time, success or failure, origination, and the data, component or resource...

mtcs-singapore::13.4 · Audit trails →
New Zealand Information Security Manual (NZISM)4 controls

Agencies should align every log and audit trail with the authoritative time source so that events carry accurate time stamps.

new-zealand-information-security-manual-nzism::16.6.11.C.03 · 16.6.11.C.03 Synchronise logs and audit trails to the time source →
FDA 21 CFR Part 113 controls

Section 11.10(e) audit trail requirement: USE OF SECURE + COMPUTER-GENERATED + TIME-STAMPED AUDIT TRAILS to independently record the date and time of operator entries and actions that create + modify + or delete electronic records.

Part11.AuditTrail · Audit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e)) →
FDA Quality Management System Regulation (QMSR)2 controls

Section 820.35 establishes FDA-specific record-control requirements that supplement ISO 13485:2016 Section 4.2.5. SPECIFIC REQUIREMENTS: (a) RECORD RETENTION - records must be retained for a period of time equivalent to the design + expected life of the device...

QMSR-820.35 · Control of records - record retention, audit trail, UDI, medical-device reporting (§820.35) →
ICH E6(R3) - Good Clinical Practice2 controls

ICH E6(R3) Annex 1 (Computer Systems Used in Clinical Trials) is the new section consolidating data integrity + electronic systems + computer system validation (CSV) - replacing scattered E6(R2) provisions.

ICH-E6-Annex1-ElectronicSystems-CSV-eSig-Audit-ALCOA-DataIntegrity · ICH E6(R3) Annex 1 - Computer Systems + Computer System Validation (CSV) + Electronic Signature + Audit Trail + ALCOA+ Data Integrity →

Questions people ask about audit trail

What is Audit Trail?
A chronological record of system activities that enables the reconstruction and examination of events. Essential for forensic analysis and regulatory compliance.
Why is Audit Trail important for compliance?
Audit Trail is a key concept in Audit. Understanding audit trail helps organizations meet regulatory requirements, reduce risk, and demonstrate due diligence during audits. Our compliance platform maps 1,016 frameworks with 316K cross-framework control mappings.
What concepts are related to Audit Trail?
Key concepts related to Audit Trail include SIEM (Security Information and Event Management). Understanding these interconnected concepts provides a more comprehensive view of Audit requirements and helps organizations build holistic compliance programs.
Which compliance frameworks address Audit Trail?
Audit Trail appears in the requirement text of RBI Cybersecurity Framework for Banks, MTCS (Singapore), New Zealand Information Security Manual (NZISM), FDA 21 CFR Part 11, FDA Quality Management System Regulation (QMSR). Across these standards we have identified 21 controls that name it directly, each linked to the control text on the compliance platform.
Where can I learn more about Audit Trail?
Explore our compliance framework pages to see how audit trail applies across different standards and regulations. Our implementation guides provide step-by-step guidance, and the compliance platform offers AI-powered analysis of how this concept maps across 1,016 frameworks.

See how Audit Trail applies across compliance frameworks

Our platform maps 1,016 frameworks with 316K cross-framework control mappings. Explore how this concept is addressed across standards.

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Written and maintained by Gerard Blokdyk, The Art of Service.