Services / AI Governance and Assurance

AI Governance and Assurance

AI Governance and Assurance

CliniGene helps establish the controls required to use AI responsibly in regulated life-sciences operations.

Schedule a Consultation Email hello@clini-gene.com

CliniGene helps establish the controls required to use AI responsibly in regulated life-sciences operations.

AI-generated content remains a draft until it has been reviewed and approved by an authorized individual.

AI-generated content remains a draft until it has been reviewed and approved by an authorized individual.

Services Include

  • AI governance framework
  • AI acceptable-use policy
  • Roles and responsibilities
  • Risk-classification model
  • Intended-use documentation
  • AI vendor qualification
  • Human-review requirements
  • AI output-verification strategy
  • Model-change controls
  • Incident and escalation procedures
  • Training and adoption support
  • Periodic performance reviews
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How we take this further

A policy that says “use AI responsibly” does not tell a reviewer when a draft may be filed, who qualifies a vendor, or what happens when a model version changes. Governance has to be specific enough to train against and to show an inspector.

CliniGene writes the framework, the acceptable-use rules, the intended-use records, and the human-review bar. Your authorized individuals still approve.

Standards we score against

  • Your quality system and document-control SOP
  • Data-integrity and privacy requirements that apply to the data AI may see
  • Vendor qualification / supplier SOP when a model or copilot is a supplier
  • Change control for model, prompt, or vendor updates
  • Training SOP for anyone who will use or review AI output

Where teams get stuck

  • Acceptable use is a slide, not a controlled procedure
  • No intended-use record for the actual GxP activity
  • Vendors unqualified beyond a security questionnaire
  • No written human-review requirement before filing
  • Model or prompt changes with no change control

Who it is for

Quality, Clinical, Regulatory, and Technology leaders who need written controls before AI touches GxP work — and who will keep approval authority inside the company.

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.

Policy draft

AI produces a first draft of acceptable use, roles, and review rules in your template. Quality edits until it matches how you work.

Intended-use capture

Each approved use gets a draft intended-use note: who, what records, what the model must not do.

Vendor file assist

Questionnaires and vendor packs are mapped to your supplier SOP. Qualification decisions stay with QA.

Change and incident language

Model-change and escalation procedures are drafted so periodic review has something to measure against.

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

    Confirm the uses in scope

    Only the AI uses you intend to allow in regulated operations, informed by the readiness assessment when you have one.

  2. 2

    Write the framework and policy

    Governance framework, acceptable-use policy, and roles — in your document-control path.

  3. 3

    Set the risk model

    How uses are classified and what controls each class requires.

  4. 4

    Document intended use

    One record per approved use, boring and true.

  5. 5

    Qualify vendors

    AI vendors assessed under your supplier process, not a brochure restatement.

  6. 6

    Define human review and verification

    Who must review, what they check, and how output is verified before it is official.

  7. 7

    Install change and incident paths

    Model, prompt, and vendor changes; incidents and escalation.

  8. 8

    Train and review

    Adoption support and a periodic performance review so the framework does not die in a binder.

What a typical engagement looks like

Setting. Typical: after a readiness assessment, one or two GxP-adjacent uses are allowed to proceed if controls exist.

What we do. Framework, policy, intended-use records, vendor qualification, human-review rules, change and incident procedures, training outline.

What you can show. AI-generated content remains a draft until an authorized individual reviews and approves it — and you can show that rule in a procedure.

Time

A first governance pack for a defined set of uses is often four to eight weeks including Quality review.

What we need from you

  • Quality and IT owners for AI
  • Current acceptable-use or data-integrity policy if any
  • Vendor list and packs for in-scope tools
  • Document-control and training templates

You receive

  • AI governance framework
  • AI acceptable-use policy
  • Roles and responsibilities
  • Risk-classification model
  • Intended-use documentation
  • AI vendor qualification support
  • Human-review requirements
  • AI output-verification strategy
  • Model-change controls
  • Incident and escalation procedures
  • Training and adoption support
  • Periodic performance-review plan

Questions we hear first

Will AI approve quality records under this framework?
No. AI will not independently approve or close quality records, approve CAPAs, or replace Quality approval.
Do we need the readiness assessment first?
It is the usual start. If you already have a clear inventory, we can begin with governance.

Start with AI Governance and Assurance

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

hello@clini-gene.com

Schedule a Consultation Email hello@clini-gene.com

Talk with us about AI Governance and Assurance

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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