VALID Trust is a public methodology for qualifying AI suppliers in regulated life sciences. It scopes qualification to what the AI actually does in your workflow, across four pillars and five steps, and marks where inherited validation ends and the sponsor's own work begins.

Read the VALID Trust framework →

VALID Trust Assessment · AI supplier qualification

From evidence inventory to a defensible qualification recommendation.

The VALID Trust Assessment applies the methodology to a specific supplier, system, and context of use, and produces the weighting, scoring, and traceability your Quality function needs to make the qualification call.

Sponsors

You're qualifying an AI supplier

Your team has to decide whether a probabilistic system can be relied on in a GxP process, and the standard supplier package wasn't built for that question.

Sponsor engagement options ↓
Vendors

You're preparing for sponsor audits

Your customers' CSV and Quality teams are asking sharper questions about models, harnesses, and change. You want the evidence ready before they ask.

Vendor engagement option ↓

If you've completed the Harness Evidence Worksheet, you already have the inventory. This is what comes next.

01 / Worksheet vs. assessment

What the worksheet gives you, and what an assessment adds

Harness Evidence Worksheet · free

The inventory

  • An evidence inventory across the harness and supplier boundary
  • A status for each evidence element
  • Critical-path tags for your context of use
VALID Trust Assessment

The judgment layer

  • Criticality weighting of each evidence element for your context of use
  • Scoring against the applicable VALID Trust pillars
  • A residual-risk recommendation
  • Traceability mapping to GAMP® 5 Second Edition and EU GMP Annex 11

Scored by a deterministic rules engine, so the same evidence produces the same result. Every judgment call is recorded, and the rules ship with the report so your reviewer can check the scoring.

The decision stays with the sponsor. The assessment supports your supplier qualification; it doesn't replace it. The qualification decision, and the accountability that comes with it, remain with your Quality function.

02 / The method

Four pillars decide what's assessed. Five steps decide the order.

PILLAR 01

Generative AI Validation

When the AI generates content: provenance, reproducibility, and grounding of what it produces.

PILLAR 02

Agentic AI Governance

When the AI acts: how far its autonomy reaches and where human oversight is wired in.

PILLAR 03

Probabilistic Acceptance

When outputs vary: whether that variance is bounded, calibrated, and quantified.

PILLAR 04

Continuous Monitoring

When the system can change: how change is detected, versioned, and governed after deployment.

  1. Map the vendor to the pillars. Determine which pillars apply based on what the system actually does.
  2. Run the pillar-specific questions. Work through the qualification questions for each applicable AI modality.
  3. Apply the cross-cutting threads. Run security and supplier-qualification checks uniformly across every applicable pillar.
  4. Locate the validation-inheritance boundary. Mark where inherited validation ends along the supply chain and the sponsor's own work begins.
  5. Scope the qualification recommendation. Consolidate findings into a scoped recommendation, with residual sponsor obligations named explicitly.

The pillars and steps are public and licensed CC BY 4.0. Read the methodology · Zenodo DOI:10.5281/zenodo.23089779

03 / Engagement options · sponsors

Sized to how many suppliers and contexts of use are in scope

Scope and fixed fee are quoted in writing before any work begins.

Tier A

AI Supplier Assessment

What's assessed
One supplier, one system, one context of use.
What you receive
Weighted scoring, a residual-risk recommendation, and the regulatory traceability mapping.
Typical duration
2 weeks
Tier B

Multi-Supplier or Multi-CoU AI Assessment

What's assessed
Several suppliers, or one system across several contexts of use.
What you receive
A Tier A deliverable per supplier or CoU, plus a consolidated cross-comparison of residual risk.
Typical duration
2-4 weeks
Tier C

AI Supplier Assessment & Training

What's assessed
A Tier A or Tier B scope, run alongside your team.
What you receive
The assessment deliverables, plus training so your team can run the next assessment in-house.
Typical duration
4-6 weeks

04 / Engagement options · vendors

Answer the sponsor's questions once

Supplier evidence package

Structured evidence, ready for sponsor audits

What you receive
Your evidence, structured and mapped to the VALID Trust pillars, in the form sponsor Quality teams will ask for it.
Why it helps
You answer the sponsor's questions once, rather than reassembling the same evidence at every audit.
Typical duration
4-6 weeks

An assessment is not a certification, approval, or endorsement, and no mark or seal is issued.

05 / How it starts

Start with a free 30-minute Fit Check

  • No cost
  • No PO
  • No commitment
  • Public-disclosure level only
Book a Fit Check →

If your question turns out to be broader than one supplier, the Fit Check may point you to the AI Exposure Screen instead.

Builds on

  • GAMP® 5 Second Edition
  • ICH Q9(R1) Quality Risk Management

Community of Practice leadership is a volunteer role. Britt Biocomputing is not affiliated with, endorsed by, or acting on behalf of ISPE. GAMP® and ISPE® are trademarks of the International Society for Pharmaceutical Engineering.