SAFE GxP DVT

Safe, agnostic, fast, and end-to-end digital validation

Valkit is built for regulated teams: human-controlled AI, open LLM architecture, rapid drafting, and one continuous lifecycle from requirements through sign-off.

HITLOptionalOpenOne

The S.A.F.E. framework

AI drafts. Qualified people decide.

Four product principles that shape every AI and lifecycle path in Valkit.

S
SafeEvery AI output needs mandatory human review and e-signature before it becomes part of the controlled record.
A
AgnosticChoose Valkit-managed, OpenAI, Claude, Gemini, Azure OpenAI, or no AI provider. Swap without rewriting your program.
F
FastGenerate requirements, risks, and test steps from system descriptions, uploads, and legacy unstructured sources.
E
End-to-endRequirements, risk, execute, and approve in one system with continuous traceability: inspection-ready by design.

Positioning

What SAFE is (and is not)

✓ SAFE is✕ SAFE is not
The product method for digital validation with optional AIA separate SKU
Validated RAG frameworks and human-in-the-loop controlsA promise that the third-party LLM itself is GxP-validated
AI that augments SMEs, with a validation package on major releasesA replacement for SME review or approval

How SAFE shows up in the product

Governance first, speed second, not the other way around.

  1. 1

    Configure the org LLM

    Pick a provider under Organization Settings → AI, or set none to hide AI across the product.

  2. 2

    Draft with scoped AI

    Generate requirements, risks, steps, or change proposals from package context, not an open chat.

  3. 3

    Human disposition

    Authors review, edit, accept, or dismiss. Provenance badges keep LLM origin visible.

  4. 4

    Sign the controlled record

    PIN-backed e-signatures and workflow gates stay on the approved path. AI never skips them.

Buyer questions

Answers teams ask in diligence

No. Customer data is not used to train models.

Inference is scoped to package context plus the user prompt.

Yes. Organization Settings can hide AI controls entirely, org-wide. Critical workflows still complete without AI.

No. Every AI output is a proposal until a human accepts it. Evidence, lineage, and Part 11–oriented signatures stay on the controlled path.

Need more depth for a security questionnaire? Our Security and Responsible AI pages cover it.

Responsible AI
Also see:Security
Step 1 of 6 · PromiseThe validation lifecycle
Next · 2 WriteDocuments & ContentsAuthor, version, and e-approve validation documentsPrevious: AI for validation
SAFE GxP Digital Validation Tool | Valkit.ai