# AI-assisted deviation investigations and CAPA
An AI-assisted investigation uses AI to prepare the groundwork of a deviation investigation: the problem statement, similar past events, root cause candidates and a draft CAPA plan. The investigator and QA review, edit and approve every part. The AI drafts; it does not conclude.
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## What the AI drafts
- The problem statement in IS / IS NOT form, from the initial report
- Similar past events across batches, equipment and sites
- Root cause candidates by fishbone category, each with the evidence it came from
- 5-Whys chains for the candidates your investigator keeps
- A draft CAPA plan with owners, timing and effectiveness checks

## Why it shortens cycle time
Most of the elapsed time in an investigation goes to gathering: finding the batch record pages, the earlier deviations, the lab results and the procedure in force. When that arrives as a sourced draft, the investigator starts by checking and deciding instead of starting from a blank page, and the quality of the write-up depends less on who was available.
We baseline deviation cycle time, backlog age, recurrence and right first time in the assessment, and report against the same measures afterwards.

## How it stays inspection-ready
21 CFR 211.192 requires unexplained discrepancies to be thoroughly investigated, with a written record of the conclusions and follow-up. The AI's part in that record is visible, not hidden.
- Every AI draft is labelled as AI-generated and quotes the document it relied on
- Edits, acceptances and rejections are recorded in the audit trail with a reason
- The record is signed by the people accountable for it
- Models and prompts are under change control

## Your qualified people decide
- Classification, product impact and reportability are decided by qualified people.
- Root cause is concluded by the investigator and approved by QA.
- CAPA actions are accepted or rejected one by one, and the record is signed by a person.

## Frameworks this work is built to
- 21 CFR 211.192
- 21 CFR Part 11
- ICH Q9(R1)
- ICH Q10
- EU GMP Annex 11

## Included
- IS / IS NOT problem statements
- Fishbone
- 5-Whys
- CAPA effectiveness checks

## Questions about AI-assisted investigations

### Does the AI decide the root cause?

No. It proposes candidates with the evidence for each. The investigator rules candidates in or out, concludes the root cause, and QA approves it.

### Is AI allowed in GMP investigations?

The regulations require a thorough, documented investigation and accountable review by the quality unit. They do not specify the tools used to prepare it. The controls that matter are a defined intended use, validation scaled to risk, human review and approval of every GxP decision, and an audit trail of what the AI contributed.

### What data does the AI read?

Only the sources you connect and allow: typically the deviation report, batch records, lab results, procedures and earlier quality records. Access is least-privilege and every source read is recorded.

### How do you know the AI draft is right?

Each statement in a draft is tied to a quoted source, so a reviewer can check it. The function is tested against acceptance criteria during validation and monitored afterwards, and a draft is never the final record until a qualified person has reviewed and approved it.

## Related services
- QMS digitizationConfigured on the platform that fits your size and product type.
- Connected quality dataYour QMS linked to plant and lab systems for trending, recurrence detection and earlier signals.
- Validation of AI-enabled systemsRisk-based validation following GAMP 5 (Second Edition) and computer software assurance principles, documented for inspection.
- Agentic workflow automationOrchestrated agents that take on routine quality work across your systems: gathering, checking, drafting and chasing. Each one works inside defined guardrails and hands decisions to your people.

## Talk it through with someone who has run a plant
Bring your backlog, your systems map or one investigation that keeps coming back. We will tell you plainly what we would do and what we would leave alone.
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In the first meeting we cover
- Your current QMS and how it connects to MES, LIMS and ERP
- Where deviations, CAPAs and change controls slow down
- Whether a readiness assessment makes sense, and what it would cover

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Source: https://qlogix.ai/services/ai-assisted-investigations
QLogix · contact@qlogix.ai · +17146639012