AI for validation

Scoped AI drafts you review and approve

Valkit AI is purpose-built for GxP packages: requirements, risks, test steps, extraction, and change proposals. Human-in-the-loop is mandatory. Use is optional. Nothing auto-approves into the controlled record.

ScopedHITLOffOpen

What we do, and do not do

Not an open chatbot. Scoped actions on your package.

✓ Valkit AI does✕ Valkit AI does not
ScopeDraft requirements, risks, test steps, and change proposals from package contextOpen-ended chat for arbitrary questions
ProviderRun on the provider you choose: Valkit, OpenAI, Claude, Gemini, Azure, or noneForced model lock-in

What AI can do

Clear product actions, not vague “AI magic.”

Draft requirements, specifications, and section content from package context and existing rows.

Assist impact, verification, and related risk fields, still reviewed by SMEs before they stay.

Generate steps after linking, including process-diagram context when present.

Propose section updates from a pasted change. Authors accept or dismiss. Never auto-apply.

AI origin badges and LLM provenance stay visible on generated content.

Set the org LLM to none and AI controls disappear. Manual authoring and paste/import still work.

How AI stays governed

Same SAFE rules on every surface.

  1. 1

    Enable a provider (or not)

    Organization Settings → AI. Choose a provider or none.

  2. 2

    Run a scoped action

    Add with AI, generate steps, extract from a file, or start Change intelligence, always on a known surface.

  3. 3

    Review the proposal

    Edit, delete, accept, or dismiss. You own the decision.

  4. 4

    Sign as usual

    Normal review and Part 11 signatures apply. AI never replaces the approver.

Why is it safe for GxP? SAFE explains the method and governance behind every AI action.

SAFE GxP DVT
Also see:Responsible AI
Step 6 of 6 · AccelerateThe validation lifecycle
Back to start · 1 PromiseSAFE GxP DVTSafe, agnostic, fast, and end-to-end digital validationPrevious: Change intelligence

FAQ

Common questions

What does AI do in Valkit?

It drafts specific parts of a GxP validation package from the package context: requirements, risks, test steps, content extracted from files, and change proposals. It is not an open chatbot.

Can AI approve or change validation records on its own?

No. People review every AI proposal and accept, edit or dismiss it. Normal review and 21 CFR Part 11 signatures still apply, and AI never replaces the approver.

Do we have to use AI?

No. AI is optional by policy. Set the organization’s AI provider to none and the AI controls disappear, while manual authoring and import keep working.

Which AI models does Valkit support?

You choose the provider: Valkit, OpenAI, Claude, Gemini or Azure, or none at all. There is no model lock-in.

Can we tell which content came from AI?

Yes. AI origin badges and the model provider stay visible on generated content.

AI for GxP Validation | Valkit.ai