21 CFR Part 11 Audit Trails Software

Clause‑mapped, append‑only audit trails with UTC timestamps, electronic signatures, and exportable evidence for FDA inspections.

Validation Pack (URS/IQ/OQ/PQ) – available on request. Contact us to receive templates and protocols aligned to Part 11 audit‑trail controls. Contact Us

Introduction

Electronic records in pharmaceutical environments must be trustworthy, reliable, and readily retrievable for their full retention period. Under 21 CFR Part 11, audit trails are central to demonstrating data integrity, accountability, and electronic signature trust. This page explains how Parakeet Risk implements clause‑mapped audit‑trail controls aligned to Part 11, with concrete before/after examples and a validation pack outline. For a broader view of our life‑sciences capabilities see Pharma and for platform details see Features. For continuous monitoring workflows and audit‑trail review automation, see the sibling page: 21 CFR Part 11 Continuous Monitoring & Audit‑Trail Review.

What Part 11 requires for audit trails (plain‑language summary)

• 11.10(e): Computer‑generated, time‑stamped audit trails that independently record date/time of operator entries and actions that create, modify, or delete electronic records; no obscuring prior information; audit trails retained at least as long as the associated records; available for FDA review and copying.

• 11.10(c): Protect electronic records to enable accurate and ready retrieval throughout the retention period.

• 11.10(d) and 11.300: Restrict system access to authorized individuals; establish identification code/password controls (e.g., periodic password changes, loss management, transaction safeguards).

• 11.50: Signature manifestation must include printed name of signer, date/time of signing, and the meaning (e.g., review, approval, responsibility) associated with the signature.

• 11.70: Signature/record linking so that signatures cannot be excised, copied, or transferred to falsify an electronic record.

Clause‑mapped audit‑trail controls in Parakeet

Implementation specifics

• UTC as the system source of truth

• Canonical timestamps are stored in UTC to avoid DST/time‑zone ambiguity; UI and exports show both local time and UTC offset where helpful.

• Append‑only audit events

• Audit events are append‑only; edits create a new event that references the prior state so earlier information is never overwritten or obscured (per 11.10(e)).

• Access and authentication

• Access is restricted to authorized individuals; credentials are managed per good security practice consistent with 11.300 (e.g., periodic password changes as configured by customer policy).

• Signature manifestation and meaning

• For e‑signatures, Parakeet displays and exports the printed name, date/time of signing, and meaning (11.50). The signature is linked to the record to satisfy 11.70.

• Retention and retrieval

• Audit trails are retained at least as long as the records they support and can be exported on demand to support inspection readiness (11.10(e), 11.10(c)).

Data captured per audit‑trail event

• Actor: unique user ID and role in effect at the time of the action.

• Record identifiers: object type, primary key, and version.

• Action type: create, modify (field‑level deltas), delete, sign, withdraw, approve, reject.

• Timestamps: event time (UTC), optional display in local time with offset.

• Signature manifestation (when applicable): printed name, date/time, meaning.

• Optional fields (configurable): reason for change; reference to related CAPA, deviation, or change control.

Before/after examples

Audit trail: what’s captured in 120 seconds (walkthrough)

• 0:00 – 0:20: User signs in with unique credentials; role and permissions are loaded. Parakeet records actor_id, role, and session metadata for traceability (11.10(d), 11.300).

• 0:20 – 0:40: A record is edited. The system captures object type, record_id, version, event_id, fields changed, old_value → new_value, and immutable event_time_utc (rendered with local offset in UI/exports) (11.10(e)).

• 0:40 – 1:05: Change reason is prompted (if configured) and stored alongside the event. Prior state is preserved and viewable—no overwrites (append‑only) (11.10(e)).

• 1:05 – 1:25: A reviewer applies an electronic signature for approval. Signature manifestation includes printed name, meaning (e.g., Reviewed/Approved), and date/time, bound to the specific record version (11.50, 11.70).

• 1:25 – 1:45: An auditor filters the audit log by record, actor, date range, event type, and meaning to verify history and independence of review; UTC timestamps and offsets are visible.

• 1:45 – 2:00: The auditor exports the audit trail (CSV/PDF). Export mirrors on‑screen columns and retains canonical UTC timestamps plus prior values for complete reconstruction (11.10(e)).

One‑click: Export audit trail CSV (how‑to)

1) Open the record or global Audit Log. 2) Select Export > Audit Trail CSV. 3) Apply filters (record, date range, actor, event type, signature meaning) as needed. 4) Click Export. Your CSV includes: event_id, record_id, record_version, actor_name, actor_id, role, action_type, field, old_value, new_value, event_time_utc, event_time_local_offset, signature_name, signature_meaning, signature_time_utc, change_reason.

{
  "@context": "https://schema.org",
  "@type": "HowTo",
  "name": "Export audit trail CSV in Parakeet",
  "description": "Create a Part 11-ready audit trail export with canonical UTC timestamps and prior values preserved.",
  "totalTime": "PT1M",
  "step": [
    {"@type": "HowToStep", "name": "Open Audit Log", "text": "Open the record or global Audit Log in Parakeet."},
    {"@type": "HowToStep", "name": "Choose Export", "text": "Select Export > Audit Trail CSV."},
    {"@type": "HowToStep", "name": "Set filters", "text": "Filter by record, date range, actor, event type, and signature meaning as required."},
    {"@type": "HowToStep", "name": "Download CSV", "text": "Click Export to download the CSV with UTC timestamps, local offsets, and field-level deltas."}
  ]
}

Download the Part 11 Validation Pack

Accelerate validation with a ready‑to‑tailor package focused on audit‑trail controls:

• URS (User Requirements Specification) covering 11.10(c/d/e), 11.50, 11.70, 11.300, UTC handling, change‑reason capture, retention, and exports.

• IQ/OQ/PQ protocols with objective evidence templates (append‑only behavior, UTC rendering, export fidelity, permission boundaries, signature manifestation/linking, retention).

• VSR (Validation Summary Report) template with deviation log and residual risk statement.

• Traceability Matrix (URS ↔ risks/controls ↔ test cases ↔ evidence).

• SOP templates: Audit‑trail review, e‑signatures, backup/restore, account/credential management, change control, periodic review.

• Training record templates for users, reviewers, and administrators.

To request the Validation Pack, contact us via Contact Us.

• Before (non‑compliant)

• “Record updated by ‘Admin’ on 03/02/25.” No actor identity, no field‑level history, no time zone, and the prior value is lost.

• After (compliant)

• Event ID: 9f31…; Record: Batch 24‑103; Action: Modify; Field: Yield_% (from 96.4 to 97.1);

  • Actor: J. Rivera (QA Reviewer)

  • Timestamp: 2025‑03‑02 14:07:22Z (UTC)

  • Signature: Printed name “J. Rivera”; Meaning “Reviewed – Data Correction”; Date/Time 2025‑03‑02 14:07:30Z (UTC)

  • Prior state retained: Yes (viewable and exportable)

Screenshot gallery (captions—no images)

• Audit log table view

• Columns: Who, What, When (UTC with local offset), Why. Field-level diff chip (old → new), immutable Event ID, and record/version reference.

• Signature manifestation panel

• Displays printed name, date/time of signing, and meaning (e.g., Approved/Reviewed). Shows binding to the specific record version (signature/record linking).

• Time rendering tooltip

• Local time shown with explicit UTC offset; hover reveals canonical UTC to avoid DST/time‑zone ambiguity.

• Export Audit Trail CSV modal

• Filters by record, date range, actor, event type, and signature meaning. Column preview includes: event_id, record_id, record_version, actor_name, actor_id, role, action_type, field, old_value, new_value, event_time_utc, event_time_local_offset, signature_name, signature_meaning, signature_time_utc, change_reason.

• Record history timeline

• Append‑only event sequence with quick filters for create/modify/delete/sign; prior states remain viewable and exportable.

Audit‑trail evidence reviewers look for

• Computer‑generated, append‑only audit log enabled by default; prior values not obscured.

• Who/What/When/Why captured for each event; timestamps canonical in UTC with local offset rendering.

• Field‑level deltas for modifications; retained history matches the record’s retention period.

• Signature manifestation present where required: printed name, date/time, and meaning; signature/record linking demonstrable.

• Access restricted to authorized, uniquely identified users; no shared “admin” accounts for GxP records.

• Retrieval supports filtering by record, date range, actor, event type, and meaning; exports (CSV/PDF) mirror on‑screen data.

• Backup/restore includes audit‑trail data; integrity preserved after restore.

• Time synchronization approach documented to mitigate drift/DST risks.

• SOPs define audit‑trail review cadence, independence of reviewers, and evidence of findings/resolution.

Validation pack outline (Part 11 audit‑trail focus)

• URS: User Requirements Specification covering 11.10(c), 11.10(d), 11.10(e), 11.50, 11.70, 11.300; include UTC handling, change‑reason capture, signature manifestation, retention, export.

• Risk Assessment: GxP impact and data‑integrity risk (ALCOA+), including risks of clock drift, unauthorized change, partial exports, and signature detachment.

• Supplier Documentation: System description, architecture overview, release notes, and security overview.

• Configuration Specification: Roles/permissions, audit‑trail enablement, signature meanings, password policies, time‑zone display, required change‑reason toggles.

• Test Protocols and Evidence

• IQ: Environment build, time synchronization settings, permissions baselines.

• OQ: Functional tests for audit‑trail enablement by default; append‑only behavior; field‑level deltas; UTC rendering; export fidelity; permission boundaries; signature manifestation; signature/record linking; retention behaviors; error handling.

• PQ: User scenarios mirroring SOPs (e.g., review/approval of deviations, batch record edits, CAPA closure) with objective acceptance criteria.

• Traceability Matrix: URS ↔ risk controls ↔ test cases ↔ objective evidence.

• Procedure/SOP Set: Audit‑trail review SOP (frequency, roles, sampling); electronic signature SOP; backup/restore and disaster recovery; change control; account and credential management; periodic review.

• Training Records: Role‑based training for users, reviewers, and administrators.

• Validation Report: Summary of deviations, residual risks, and release recommendation.

Audit‑trail review and retention practice

• Review cadence and scope

• Define frequency (e.g., per batch, per change control, or periodic) and sampling rules in the Audit‑Trail Review SOP; reviewers must be independent of the original data entry where appropriate.

• Retrieval and export

• Ensure reviewers can filter by record, date range, actor, event type, and signature meaning; exports include UTC timestamps and the non‑obscured prior state.

• Retention

• Maintain audit trails for at least the same duration as the underlying records (11.10(e)); verify backup/restore includes audit‑trail data and preserves integrity.

Configuration options commonly used by customers

• Enforce change‑reason entry for all edits to GxP‑critical objects.

• Require multi‑factor authentication for signature authorization (in addition to 11.300 credential controls, where adopted by policy).

• Display local time with explicit UTC offset in reviewer worklists and exported PDFs/CSVs.

• Route critical audit‑trail events to collaboration tools (see Features) for rapid triage while preserving the centralized, immutable audit record in Parakeet.

Cross‑links

• Explore life‑sciences workflows, QMS integration, and data integrity on Pharma.

• See platform‑wide capabilities (dashboards, integrations, exports) on Features.

Glossary

• Audit trail: A secure, computer‑generated, time‑stamped record of operator entries and actions that create, modify, or delete an electronic record; prior information is not obscured; retained for the record’s full retention period (11.10(e)).

• Signature manifestation: Printed name, date/time of signing, and meaning of the signature (11.50).

• Signature/record linking: Technical controls that prevent detaching or moving signatures to falsify records (11.70).

• Identification code/password controls: Administrative and technical controls for credentials used to access and sign (11.300).

Important notes

• This page summarizes regulatory requirements to help structure validation and configuration; your policies/SOPs and validation evidence determine actual compliance. Parakeet supports, but does not replace, a compliant quality system.