Using AI in a validated documentation process
Your team is already using AI. The question for a regulated product is whether that AI works inside your controls or around them.
You can use AI in a validated documentation process if the AI works inside your controls rather than around them. That means every AI contribution is a draft a named person reviews, the change is recorded against that person, and nothing reaches a published, signed document without the same review and approval as human work.
The risk is the workaround, not the AI
When there is no sanctioned way to use AI, people copy document content into a chat window and paste the answer back. The content leaves your system, nobody records what changed or why, and the reviewer cannot tell which words a person wrote and which they did not. That is the version to worry about.
Four principles
- People stay accountable. A named person owns every change, whoever drafted it.
- AI output is a draft. It goes through the same review and approval as anything else before it is published.
- Every change is recorded. The audit trail shows what changed, when, and on whose behalf.
- Data stays under your permissions. The AI sees only what the person using it may see, and only when they choose to share it.
Where AI helps most
First drafts from a template, renumbering requirement IDs, finding requirements with no verification linked, checking wording for consistency, and summarising what changed between versions. These are tasks where a person can check the result quickly.
Where it should not decide
Signing, approving, releasing and risk acceptance stay with people. An AI can prepare the evidence for a decision, but the decision and the signature belong to someone accountable for it.
How it works in Traceable
The AI Connector connects the AI assistant your team already uses to Traceable through the Model Context Protocol. An administrator turns it on for the organisation, and it acts under the signed-in person's own permissions. Edits land in a draft with every change recorded against that person, and published documents still need review and e-signatures. See security and privacy for how data is handled.
Related guides
This guide is educational and does not certify any product or organisation.
Common questions
Is AI allowed in regulated documentation?
Nothing in the common quality standards forbids it. What they require is control: accountable people, reviewed and approved documents, and records of what changed. AI used inside those controls fits them.
Who is responsible for AI-drafted content?
The person who accepts it into a document, and the reviewers and approvers who sign it, exactly as for content they wrote themselves.
Does document content leave Traceable when AI is used?
Only when a person uses the AI Connector and asks their assistant to read content. The assistant then handles it under that person's agreement with their AI provider. The connector is off until an administrator turns it on.
Connect your AI to Traceable
Use the AI your team already has, inside the same controls as everything else.