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AI and GxP Readiness

AI and GxP Readiness Assessment

Before adopting AI in a regulated environment, organizations need to understand the intended use, associated risks, required controls, and expected business value.

Schedule a Consultation Email hello@clini-gene.com

Before adopting AI in a regulated environment, organizations need to understand the intended use, associated risks, required controls, and expected business value.

CliniGene evaluates your current and proposed AI use across Quality, Clinical, Regulatory, Manufacturing, and supporting technology processes.

Services Include

  • AI-use and shadow-AI inventory
  • Workflow and data assessment
  • GxP-impact determination
  • AI risk classification
  • Data privacy and security review
  • Vendor documentation review
  • Governance gap assessment
  • Use-case prioritization
  • Validation recommendations
  • 90-day implementation roadmap
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How we take this further

AI is often already in the building before anyone writes an intended-use statement. Staff paste regulated text into public tools. Vendors add copilots to eQMS, eTMF, or document systems. A well-meaning team drafts SOPs or CAPAs with a model and files the output as if it were reviewed work.

Emerging companies need to know what is already happening, which uses can affect GxP records or decisions, and what a responsible next 90 days looks like — without buying another enterprise platform.

Standards we score against

  • Your quality manual, data-integrity policy, and computer-system procedures
  • GxP intended use, patient safety, product quality, and data integrity
  • 21 CFR Part 11 / EU Annex 11 when electronic records or signatures are in scope
  • Vendor terms, data-processing, and model-training restrictions
  • Your change-control and document-control SOPs

Where teams get stuck

  • No inventory of where AI is already used, including shadow use
  • No GxP-impact determination for copilots or document generation
  • Vendor claims accepted without a documentation review
  • Governance written for IT generally, not for regulated records
  • No 90-day plan that Quality, Clinical, and Technology can share

Who it is for

Emerging biotechnology and pharmaceutical companies, clinical-stage organizations, CROs, virtual life-sciences companies, and teams already using or planning AI in Quality, Clinical, Regulatory, Manufacturing, or supporting technology processes.

What AI does — and does not do

AI supports analysis, consistency, traceability, and document preparation. Qualified professionals review every regulated deliverable, and customers retain final approval authority. AI-generated content remains a draft until it has been reviewed and approved by an authorized individual.

Questions on fit? hello@clini-gene.com or the contact form.

AI in this process

How the model is used, layer by layer

Each layer has a human gate. AI does not write the official quality record.

Use inventory

From interviews, tool lists, and tickets, AI drafts a first inventory of declared and likely shadow uses. You confirm what is real.

Impact hint

Each use is paired with a suggested GxP-impact class and the records or decisions it could touch. A specialist assigns the official class.

Gap list

Current policy, training, vendor packs, and review practices are compared to the controls a regulated use would need.

Portfolio draft

Use cases are grouped by value, risk, and readiness so the 90-day roadmap is a sequence, not a wish list.

Want this process walked on your trial or system?

Send the study, Vault, vendor, or inspection window. We will say what we need and what a first pass looks like.

hello@clini-gene.com

Schedule a Consultation Email hello@clini-gene.com
End-to-end process

Step-by-step: from intake to re-check

  1. 1

    Scope the functions

    Quality, Clinical, Regulatory, Manufacturing, and supporting technology — which are in this assessment.

  2. 2

    Inventory declared and shadow AI

    Tools, vendors, prompts, and unofficial use. Nothing is assumed safe because it is “just a draft.”

  3. 3

    Walk workflows and data

    What goes in, what comes out, where it is stored, and who can see it.

  4. 4

    Determine GxP impact

    Which uses can affect GxP activities, records, or decisions.

  5. 5

    Classify risk and review vendors

    Risk class, privacy and security, and vendor documentation — including training and retention terms.

  6. 6

    Assess governance gaps

    Policy, roles, human review, change control, and training against what the inventory requires.

  7. 7

    Prioritize and recommend

    Which uses to stop, contain, validate, or pursue — and what validation would look like.

  8. 8

    Issue the 90-day roadmap

    A practical sequence with owners, not a generic AI strategy deck.

What a typical engagement looks like

Setting. Typical: a clinical-stage biotech with Veeva or another eQMS, staff using general AI tools, and a planned document-generation use case.

What we do. Inventory, impact classes, vendor and privacy review, governance gaps, prioritized portfolio, and a 90-day roadmap Quality can approve.

What you can show. Leadership can say where AI is used, what is GxP-relevant, and what happens in the next 90 days — with customers still holding approval authority.

Time

A focused AI and GxP Readiness Assessment is commonly two to four weeks depending on how many functions and vendors you include.

What we need from you

  • List of known AI tools, copilots, and vendors
  • Quality, clinical, and IT contacts who know unofficial use
  • Relevant SOPs and any existing AI or data-integrity policy
  • Vendor documentation you can share

You receive

  • AI-use inventory
  • GxP-impact classification
  • Risk and compliance gap assessment
  • AI-governance recommendations
  • Prioritized use-case portfolio
  • Executive summary
  • Practical 90-day roadmap

Questions we hear first

Do you tell us to ban AI?
No. We classify use and recommend stop, contain, govern, or pursue. Some uses do not belong near GxP records.
Is this the same as validating a model?
No. This assessment tells you whether validation is required and what it would look like. Validation itself is a separate engagement.

Start with AI and GxP Readiness Assessment

Email hello@clini-gene.com or use the form. Mention AI and GxP Readiness Assessment so we route it correctly.

hello@clini-gene.com

Schedule a Consultation Email hello@clini-gene.com

Talk with us about AI and GxP Readiness Assessment

Email hello@clini-gene.com or send this form. The process is already selected.

Tell us the trial, Vault, vendor, or inspection date and what “done” looks like.

Contact Form

Email hello@clini-gene.com if you prefer not to use the form.

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