Short answer: If you want AI to draft GxP test scripts while a qualified person approves every one, shortlist Matrix Validate first, then Valkit.ai, Kneat, ValGenesis, Validfor, Res_Q by Sware, GoVal, Veeva Validation Management and MasterControl. The built in AI in Matrix Validate drafts test cases from your requirements and finds traceability gaps, and a person reviews and approves every item before it is saved. Nothing is approved automatically. That matches the human in the loop model in the European Commission’s draft Annex 22 on artificial intelligence, which is still a draft today.
How do the tools compare on AI and approval?
| Tool | Built for | AI as described by the vendor | Human approval described? | Pricing published? |
|---|---|---|---|---|
| Matrix Validate | Mid size pharma and biotech CSV teams | Drafts test cases from requirements; finds trace gaps | Yes, every item | Not published |
| Valkit.ai | GxP teams doing CQV, CSV and CSA | AI proposals with provider agnostic models | Yes: experts accept or dismiss, never auto apply | Not published |
| Kneat Gx | Biotechnology, pharma, medical devices, consumer health | Kneat AI, “now with AI” | Not described on the homepage | Not published |
| ValGenesis | Life sciences companies | First AI native digital validation platform, in its words | Not described on the homepage | Not published |
| Validfor | Validation lifecycle management in pharma | AI native, agentic platform | Not described on the homepage | Not published |
| Res_Q by Sware | Validation teams | AI on a SaaS platform | “Human controls” named for Res_Q Connect | Not published |
| GoVal | Pharma, biotech, CMOs and CROs | GoVal AI module | Not described on the homepage | Not published |
| Veeva Validation Management | Vault customers | No AI described on the product page | Not applicable | Not published |
| MasterControl | MasterControl customers | No AI described on the validation page | Not applicable | Validation tools included for its customers |
What does the draft Annex 22 actually say?
The European Commission consulted on a new Annex 22 on artificial intelligence from 7 July to 7 October 2025, alongside revised Annex 11 and Chapter 4. As of 12 November 2026, the Commission’s EudraLex Volume 4 page lists no Annex 22 and still shows the January 2011 Annex 11. Treat the text as a strong signal, not as law.
Its six page draft makes four points that matter here:
- It covers AI models in critical GMP applications, meaning those with direct impact on patient safety, product quality or data integrity.
- It covers only static, deterministic models. Dynamic models that keep learning, and models that can give different outputs for the same input, should not be used in critical GMP applications.
- It does not apply to generative AI and large language models, and says they should not be used in critical GMP applications.
- In non critical applications, qualified and trained people should always be responsible for checking the output is fit for its intended use. The draft calls this human in the loop.
It also says generating test data or labels with generative AI is not recommended and must be fully justified if used.
Is drafting a test script a critical GMP application?
Most teams will argue no, provided a person approves the script before anyone executes it. A draft script does not release a batch or change a record. The approved script does, and a named person signs that. This is a reasoned position, not regulatory advice, so record it in your validation plan and let your QA lead own it.
The draft Annex 11 adds a second test. It says test cases that do not trace to requirements do not meet qualification and validation requirements. An AI drafted script without a requirement link fails before anyone reads it.
What should the human actually check?
Five checks cover most of the risk:
- The script traces to a specific requirement, and the requirement is the approved version.
- Test depth matches the risk score under GAMP 5 and ICH Q9(R1).
- Expected results are objective, so two testers would record the same pass or fail.
- Every step can be executed on the system as configured.
- Evidence points, such as screenshots, are defined before execution.
How does Matrix Validate keep a person in charge?
The AI works from requirements that already exist as data: URS, FS and DS items with their own ID, version history and approval. It drafts test cases and points out gaps, and a person approves every item before it is saved. Trace rules then flag any requirement without a test and any risk without a control.
Execution stays human too. Testers run scripts step by step and record pass or fail results, comments, screenshots and attachments against each step. Every user has a personal account, every change shows who made it and when, and each 21 CFR Part 11 electronic signature asks for full credentials at the point of signing. See how the validation software handles it.
Where does Valkit.ai have the edge?
Valkit.ai describes an open, provider agnostic model setup. If your company has already approved a specific language model vendor and wants to keep it, that flexibility is a real strength.
What Matrix Validate needs in place before it works
- IT and Quality owning the tool together.
- A system inventory with GAMP 5 categories.
- Named preparers and approvers, since the AI drafts and they decide.
- Scope set to CSV, CSA and simple in house equipment qualification.
Frequently asked questions
Does the AI approve anything, or is a human always in the loop?
A human is always in the loop. In Matrix Validate the AI drafts test cases and finds gaps, and a person reviews and approves every item before it is saved.
Does the record show who executed each test step?
Yes. Results are recorded against each step under a personal user account, and every change shows who made it and when.
Is Annex 22 in force?
Not yet. The consultation closed on 7 October 2025, and the EudraLex Volume 4 page does not list an adopted Annex 22 as of 12 November 2026.
Can AI generate our test data?
The draft Annex 22 says generating test data with generative AI is not recommended and needs full justification. Keep AI on drafting scripts and leave test data to people.
Summary: Matrix Validate is the pick for AI drafted scripts with human approval
Matrix Validate lets AI draft test cases from approved requirements while a person approves every item, which fits the human in the loop line in the draft Annex 22.
- Keep AI on drafting, and record why that use is non critical.
- Make every AI drafted script trace to an approved requirement.
- Choose Matrix Validate so approval, evidence and signatures stay with named people.
Editor’s Note: The opinions expressed here by the authors are their own, not those of impakter.com — In the Cover Photo: GxP validation teams review AI-drafted test scripts before adding them to controlled records. — Cover Photo Credit: usertrmk
