LifeSciencesAIAcademy

Track 10Compliance InfrastructureLocked by prerequisiteOptional

Documentation & Audit Trails

Make AI-assisted work traceable: what was used, by whom, on what input, what was verified, what changed, and where the record lives.

6 lessons · 5 frameworks · 4–5 hours · 0/6 complete · 0/6 exercises recorded

Locked by prerequisite

This track opens once its prerequisites are complete. Prerequisites are sequenced deliberately: each one supplies a competency this track assumes you already hold.

Track 01 — AI Fundamentals
Track 02 — AI Governance & Regulatory Expectations
Track 07 — Human Accountability & Oversight

Orientation

Why this matters

An AI-assisted decision that cannot be reconstructed is, for regulatory purposes, a decision that cannot be defended. Documentation is not overhead added after the work — it is what makes the work count.

What you will be able to do (5)

Determine what must be documented when AI contributes to regulated work
Apply ALCOA+ principles to AI-assisted records
Interpret and assess an AI system audit trail
Record AI contribution, human verification and corrections
Retain and retrieve AI-related records appropriately

Aligned with (5)

ALCOA+ — data integrity principles21 CFR Part 11 — electronic records and signaturesEU GMP Annex 11 — audit trails and record controlsMHRA — data integrity guidanceICH E6(R3) — records and essential documents

Maps to published expectations. Competency demonstrated through assessment.

Regulatory alignment indicates that curriculum topics map to published regulatory expectations. It does not constitute agency approval, certification, legal advice or a determination of organizational compliance.

View source evidence, status and applicability

ALCOA+ — data integrity principles

Regulatory guidanceUnited Kingdom GxP

MHRA GxP Data Integrity Guidance and Definitions ↗

Relevant provisions: Data governance and ALCOA+ expectations across the data lifecycle
Status and date: March 2018; page updated September 2021. Current MHRA resource; OECD guidance takes precedence for UK GLP as stated by MHRA.
Why it maps: Supports the track's stated mapping to ALCOA+ — data integrity principles without transferring duties beyond the source's scope.
Applicability limit: Used for data-governance and inspection expectations. Its scope and MHRA's stated GLP qualification must be preserved.

Primary source last verified 2026-08-24

Regulatory guidancePIC/S participating authorities

PIC/S PI 041-1 — Good Practices for Data Management and Integrity ↗

Relevant provisions: Data governance, lifecycle controls, audit trails and organisational responsibility
Status and date: Adopted 1 June 2021. Guidance for regulated GMP/GDP environments; legal effect follows national implementation.
Why it maps: Supports the track's stated mapping to ALCOA+ — data integrity principles without transferring duties beyond the source's scope.
Applicability limit: Inspection-oriented guidance. It supports, but does not replace, the binding requirements of the applicable jurisdiction.

Primary source last verified 2026-08-24

21 CFR Part 11 — electronic records and signatures

Binding lawUnited States

21 CFR Part 11 — Electronic Records; Electronic Signatures ↗

Relevant provisions: §§ 11.10, 11.30, 11.50, 11.70 and 11.100–11.300
Status and date: Current electronic Code of Federal Regulations. Applies when predicate-rule records are maintained or submitted electronically and Part 11 scope is met.
Why it maps: Supports the track's stated mapping to 21 CFR Part 11 — electronic records and signatures without transferring duties beyond the source's scope.
Applicability limit: Part 11 does not make every electronic output a regulated record. Predicate rules and record use determine applicability.

Primary source last verified 2026-08-24

EU GMP Annex 11 — audit trails and record controls

GMP requirementEuropean Union GMP

EudraLex Volume 4, Annex 11 — Computerised Systems ↗

Relevant provisions: Sections 7–9 and 11–12 — storage, printouts and audit trails
Status and date: Revision January 2011. Current Annex 11; came into operation 30 June 2011.
Why it maps: Supports the track's stated mapping to EU GMP Annex 11 — audit trails and record controls without transferring duties beyond the source's scope.
Applicability limit: Applies to computerised systems used as part of GMP-regulated activities. Applicability follows the regulated process and intended use.

Primary source last verified 2026-08-24

MHRA — data integrity guidance

Regulatory guidanceUnited Kingdom GxP

MHRA GxP Data Integrity Guidance and Definitions ↗

Relevant provisions: Data governance and ALCOA+ expectations across the data lifecycle
Status and date: March 2018; page updated September 2021. Current MHRA resource; OECD guidance takes precedence for UK GLP as stated by MHRA.
Why it maps: Supports the track's stated mapping to MHRA — data integrity guidance without transferring duties beyond the source's scope.
Applicability limit: Used for data-governance and inspection expectations. Its scope and MHRA's stated GLP qualification must be preserved.

Primary source last verified 2026-08-24

ICH E6(R3) — records and essential documents

Harmonised guidelineICH regions; implemented through regional frameworks

ICH E6(R3) — Good Clinical Practice ↗

Relevant provisions: Principles and Annex 1 provisions on roles, data governance, records and oversight
Status and date: Principles and Annex 1, Step 4, 6 January 2025. Implementation depends on regional adoption and the clinical-trial activity.
Why it maps: Supports the track's stated mapping to ICH E6(R3) — records and essential documents without transferring duties beyond the source's scope.
Applicability limit: Applies to clinical trials within its scope. It should not be transferred to manufacturing or other domains without an independent basis.

Primary source last verified 2026-08-24

Full source register and editorial method →

Credential

AI Documentation and Traceability Badge

Duration

4–5 hours

Audience

Quality, validation and regulatory professionals
Anyone producing regulated records with AI assistance
Document owners and record custodians

Prerequisites

Track 01
Track 02
Track 07

Behaviours practised (2)

DocumentVerify

A batch record is queried eight months after release. The team can produce the final document and the approval signature. They cannot produce the AI input, the raw output, the model version or the verification performed — so the only defensible position is that the conclusion is unsupported.

Badge requirements (5)

Complete all six lessons and their knowledge checks
Achieve at least 80% across the final badge assessment
Answer every safety-critical question correctly
Produce a verification statement containing scope, evidence and outcome
Reject back-dating in every data integrity scenario

Lessons (6)

Final badge assessment

AI Documentation and Traceability Badge

Documentation requirements
Select all that apply and scenario classificationSafety-critical
Determine documentation requirements across six AI uses.
ALCOA+ failure identification
Match a control to a riskSafety-critical
Match ALCOA+ failures to deficient AI-assisted records.
Data integrity escalation
Choose the correct escalation pathSafety-critical
Select the correct response to four documentation gap scenarios.
Practical exercise — documentation package
Practical exercise
Assemble a complete AI documentation package and gap-assess it against the element checklist.

Next recommended track

Track 11 — Inspection Readiness