AI in the Age of Regulated Work with ALCOA+ Principles
TL;DR
- What changes with AI: You now create records at three points: training data, prompts, and outputs. Treat each as controlled.
- Records you must keep: Dataset lineage, prompt logs, model context, human reviews, and change control.
- How to pass an audit: Map every AI-touched record to ALCOA+ and show a clean audit trail that links data, model, prompt, and decision.
AI belongs in GxP when you prove data integrity at every step. The quickest way to do that is to treat training data, prompts, model context, and outputs as controlled records that meet ALCOA+ expectations. That is the central idea of this guide and the short path to inspector confidence.
Why AI Doesn’t Get a Free Pass Under GxP
AI is fine to use, but its data and decisions must meet the same integrity rules as any other electronic record under Part 11, PIC/S, and EU GMP.
Regulators already flag AI across the product lifecycle, including manufacturing. EMA’s reflection paper stresses human oversight and risk management whenever AI supports GxP decisions. The FDA’s discussion paper highlights AI’s role in monitoring and control and invites firms to show reliable evidence. Both expect clear documentation that ties AI activities to regulated outcomes.
ALCOA+ Refresher in 90 seconds
ALCOA means Attributable, Legible, Contemporaneous, Original, Accurate. The “+” adds Complete, Consistent, Enduring, Available. Apply all nine to AI data, prompts, and outputs.
MHRA’s guidance explains ALCOA and why “+” reinforces the same expectations across record types. For AI, think beyond final outputs. Keep the context that makes each output trustworthy.
ALCOA+ for AI at a Glance
| Attribute | What it means | AI example to capture |
| Attributable | Who did what and when | User ID for the prompt, system ID for automated chains |
| Legible | Readable and understandable | Full prompt text, decoded parameters, and clear labels |
| Contemporaneous | Recorded at the time of action | Time-stamped prompt and inference logs |
| Original | First capture or a certified true copy | Dataset snapshot plus checksum |
| Accurate | Correct and error-free | Validated transforms and reconciliation checks |
| Complete | Nothing missing, no hidden edits | Raw output, post-processing, and final approved record |
| Consistent | Same format and sequence | Standard fields for every prompt and output |
| Enduring | Durable for retention period | Immutable storage with retention rules |
| Available | Accessible on request | Indexed evidence pack for inspectors |
Where AI Shows Up in GxP Processes
Common GxP uses include deviation triage, CAPA trends, supplier surveillance, batch record review, and label checks, each with record responsibilities.
EMA frames AI across the lifecycle. FDA discusses AI for monitoring and control in manufacturing. If an AI system shapes a regulated decision or record, the underlying data, prompts, and outputs enter scope. Build your controls where the work actually happens.
The Three Control Planes for AI
Control integrity at three planes and link them: training data, prompts and parameters, and outputs.
1) Training Data Governance
Treat training data like a batch of reference material. You prove where it came from, what you filtered, and why it is fit for use.
- Provenance: Record source systems, versions, extraction method, and date range. Make lineage readable.
- Suitability: Document inclusion and exclusion rules, data quality thresholds, and bias checks.
- Freeze and re-use: Snapshot datasets and save hashes. That proves “Original.”
- Access control: Show who can view or change each snapshot.
- Risk-based formality: Use ICH Q9 to size the formality to impact. High-impact use needs more formality and documented rationale.
2) Prompt and Parameter Control
Prompts are specifications. If a prompt affects a regulated record, the prompt becomes part of that record’s context.
- Log everything: Store every human prompt and system instruction with user ID and timestamp.
- Automations count: For automated chains, store machine-generated prompts and branches.
- Libraries: Maintain approved prompt templates for GxP tasks. Apply change control and periodic review.
- Part 11 mapping: Make sure the log is secure, time-stamped, and tamper-evident, and that previous entries are never obscured. That language mirrors §11.10(e).
3) Output Lifecycle
An AI output is rarely the final GxP record. Capture the raw output, transformations, and the human decision.
- Chain of custody: Link model version, dataset snapshot ID, prompt ID, environment, and approver.
- Human in the loop: EMA expects defined human oversight for material decisions. Document who reviewed and what they approved.
- Retention: Keep raw and final forms for the full retention period and make them available on request. Map this to ALCOA+ “Enduring” and “Available.”
Audit Trails That Satisfy Part 11 and PI 041-1
Your audit trail should independently record who did what, when, where, and to which object across every AI event.
At minimum, capture these events with timestamps, actor, action, object ID, and old/new values:
- Dataset registration and approval
- Model registration and training run
- Deployment with version and configuration
- Inference request with prompt and parameters
- Post-processing steps
- Human review and sign-off
- Change control record and release
This aligns with Part 11 audit-trail expectations and PIC/S guidance on data integrity in GMP/GDP environments.
Model Changes, Releases, and Periodic review
Treat model weights, architectures, and prompt libraries as configuration items under change control with risk-based validation.
For every change, apply ICH Q9: assess impact, decide the level of formality, and perform targeted challenge tests when needed. Record rationale, results, and approvals. Schedule periodic review to check for usage drift, data drift, false positives or negatives, and CAPAs opened from AI errors.
Vendor and Cloud Oversight Under Annex 11 & 22
Extend supplier controls to AI vendors and cloud platforms and keep exportable evidence.
EU GMP Annex 11 is being revised, with a current consultation that strengthens lifecycle controls and supplier oversight, and introduces a new Annex 22 on AI. Plan for SLAs on availability, incident reporting, model updates, data residency, and evidence exports from your supplier. Build these into qualification and contracts now.
EU AI Act: Why QA Should Care
The AI Act entered into force on 1 August 2024 with phased obligations through 2026 and beyond; align its governance with your GMP evidence.
Official pages confirm the entry into force on 1 August 2024 and staged application. Many obligations for general-purpose models began in 2025, and most high-risk system requirements apply by August 2026. Use this timeline to tune your validation and supplier oversight plan, not to replace GMP rules.
A Practical, Inspector-Friendly Evidence Pack
Make it possible to open five artifacts and see the whole story in minutes.
- Data lineage report for the training snapshot used by the live model
- Prompt log for the specific record under review
- Output bundle: raw model output, post-processing, and human approval
- Model version register with change record and release notes
- Challenge test summary with risk assessment under ICH Q9
Tables and Templates You Can Copy
Prompt Log Fields (for GxP AI prompts)
| Field | Description |
| Record ID | Links to the regulated record |
| User ID and Role | Authorship for Attributable |
| Timestamp (UTC) | Contemporaneous prompt time |
| Prompt text (full) + hash | Legible, verifiable content |
| System instructions | Hidden context that shaped output |
| Parameters | Temperature, pressure, max tokens, etc. |
| Model name and version | Reproducibility |
| Context sources | Files, KB entries, or snapshots |
| Output hash + file link | Tie prompt to output |
| Approval user and timestamp | Human oversight |
| Change ticket | If from a library, reference the change |
Map these fields to Part 11 audit trail language and store in an immutable, time-stamped log.
Training Dataset Register (minimum)
| Field | Description |
| Dataset ID and business purpose | Why this data exists |
| Source systems and versions | Provenance |
| Extraction method and time range | Repeatable pull |
| Inclusion/exclusion criteria | Suitability |
| Data quality checks + results | Accuracy evidence |
| Bias checks summary | Fitness for use |
| File hashes and storage location | Original and Enduring |
| Access control group | Least privilege |
| Approver and date | Accountability |
| Change control links | Lifecycle traceability |
Scale formality using ICH Q9. High-impact use cases need more formality and stronger evidence.
Common Pitfalls that Break ALCOA+ Principles in Data Integrity
Most issues come from missing context, auto-updates without control, and treating prompts as “notes.”
- “We log the final output only.”
- Breaks: Complete and Original
- Fix: Save raw output and post-processing with hashes.
- Breaks: Complete and Original
- “Prompts are developer notes, not records.”
- Breaks: Attributable and Contemporaneous
- Fix: Log full prompts with user IDs and timestamps; make immutable. Part 11 supports this expectation for electronic records with audit trails.
- Breaks: Attributable and Contemporaneous
- “Model auto-updates without change control.”
- Breaks: Consistent and Accurate
- Fix: Register model versions, assess risk, and release under change control using ICH Q9 formality.
- Breaks: Consistent and Accurate
- “Training data was a moving target.”
- Breaks: Original and Enduring
- Fix: Freeze snapshots with checksums, document extraction, and control access.
- Breaks: Original and Enduring
How Validfor Helps (Product-Light)
- Proven lineage for datasets, prompts, models, and outputs with immutable trails
- Impact assessments and controlled releases for models and prompt libraries
- Challenge testing with ICH Q9 aligned evidence
- Capture AI errors and link to CAPA
- Drift checks, metrics, and closeout criteria
FAQs
Is prompt logging really required under Part 11 audit trail rules?
If prompts influence GxP records or decisions, they are part of the record context. Part 11 expects secure, time-stamped audit trails that do not obscure earlier entries. That maps cleanly to full prompt logging with authorship, time, and changes.
Do we need to validate the AI model like any other GxP system?
Yes. Validate intended use, not general intelligence. Use ICH Q9 to size testing, include challenge tests, and control the model and prompt library under change procedures.
How does the EU AI Act affect our GMP validation?
The AI Act adds horizontal AI obligations across the EU. Many map to evidence you already keep for GMP, like risk management, documentation, and supplier oversight. Track the phased obligations through 2025 and 2026 and coordinate with legal for high-risk classifications.
What if we use a vendor LLM API?
Apply supplier oversight. Qualify the provider, set SLAs for updates and incidents, define data handling and residency, and ensure you can export evidence on demand. The Annex 11 revision and consultation underscore lifecycle and supplier controls.
References
- MHRA GxP data integrity guidance and ALCOA+ clarification.
- 21 CFR Part 11 audit trail language from eCFR.
- EU AI Act entry into force and timeline.
- Annex 11 & 22 draft revision and consultation (2025).
ICH Q9 Quality Risk Management.
