Make AI inspection-ready. And prove it to the people who come to check.
Senior-led governance that takes an AI tool from idea to a clean inspection, for the QA, validation and IT teams in pharma, biotech and CDMOs who carry the risk.
Where are you right now?
Pick the one that sounds like your month. Each gives you a useful first step, and none of them is a sales call.
An inspection is coming, and AI is now in scope.
Find your gaps in 6 minutes → QA IT & CSV specialistsYou've been told to put AI into a GxP system and prove it holds up.
See how it's governed → CSV specialistsCSV paperwork is drowning the team and the backlog keeps growing.
See the CSV to CSA path → CIO & CQOYou own the budget, the risk and the inspection outcome.
Get a senior read in 30 minutes →Grouped around the problems you are solving
Everything is built for regulated environments and inspected programmes. Most clients start with one service and grow into the next.
AI and Analytics in GxP
We help you turn AI and advanced analytics from an inspection concern into a governed, validated capability across quality, manufacturing and oversight.
· AI-enabled QMS design and governance
· AI in GxP governance and Annex 22-aligned controls
Validation Transformation
We modernise validation so it matches how you actually build and run systems: from traditional CSV to CSA, and from paper to digital, across on-prem and cloud.
· CSV to CSA transformation
· Digital validation and e-validation
· GxP cloud qualification and lifecycle controls
· Lab systems and automation
Digital Quality & QMS
We design digital quality and QMS evolutions that keep up with products, markets and regulators, instead of relying on one-off exceptions and patches.
· Digital Quality and QMS 2.0 roadmaps
· eQMS selection, design and rollout oversight
· Deploying Veeva, validated right
One path, from an honest read to a system that stays in control
You don't have to start with a transformation programme. Most begin with a free self-check, and the pieces connect into one path.
A free six-minute self-check, or an inventory of where you really stand. No sales call.
A 4 to 6 week fixed-scope review, ending in a board-ready view of risk, effort and options.
Frameworks, governance and senior steering so your teams execute with confidence.
On-call advisory for inspections, new system categories and the hard cross-functional calls.
The method that sets us apart
This is what makes TrustBridge more than a single adviser: a method quality, IT, vendors and regulators can all follow, each framework deployed at enterprise scale and held up under inspection.
Two recent engagements, anonymised
Real programmes, real numbers, client names withheld by agreement. This is what the frameworks look like when they land.
From legacy CSV to a working CSA operating model in four months
A global biopharma needed its validation practice moved from document-heavy CSV to risk-based CSA without disturbing inspection readiness. The DRIVE operating discipline went live in four months: calibrated risk decisions, right-sized templates, retrained reviewers. The first quarter alone returned a 23% reduction in validation effort and 36% faster system deployments. The programme paid for itself within five months. On that foundation the client harmonised its global validation processes across sites in twelve months and went live with full eValidation in eighteen.
An AI validation framework in three months, nine AI projects live, three inspections cleared
A mid-size pharma wanted AI inside its QMS but had no way to validate it that an inspector would accept. We built their AI validation framework in three months and deployed it in two more. On those rails the client took nine AI projects live across QMS optimisation, returning savings of more than 15 million dollars. After go-live, the AI-enabled quality system went through FDA, MHRA and Russian health authority inspections, and cleared all three.
A named, deployed method. Proven in inspection, not on slides.
Years of industry standard reviews and contributions, and a speaker at more than 70 global forums. The governance I build is shaped by where the rules are heading.
Quality IT and digitalisation led across global pharma: ~15,000-user eQMS, paperless validation over 40+ sites, 2,000+ servers migrated in six months.
Live AI in GxP quality: more than 20 tools deployed, 4 applications validated, and 3 taken through a Health Authority inspection with zero compliance observations. The crown jewel, and most clients' hardest problem.
Validating AI in GxP: A Practitioner's Guide
The same method, written down. Across 19 chapters and 28 templates it covers the regulatory spine, how to classify and risk-tier AI use cases, how to build validation evidence that holds, and how to monitor a model after go-live. Written for quality, validation and IT leaders who already know CSV and need what comes next.
Find your gaps before an inspector does.
Two free, six-minute self-checks: the AI-in-GxP Readiness Index and the CSA Maturity Index. See exactly where you stand and get a tailored read. No sales call.
Worked out in the open
What the Annex 22 (AI) draft really asks of you
What the draft expects on intended use, data and human oversight, and what to build before it is final.
Read →Why most pharma transformations stall, and how to be in the few that do not
The root causes that stall digital quality programmes, and the habits of the ones that land.
Read →AI will not remove documentation from validation. It will remove uncertainty.
Where AI genuinely changes validation work, and where human judgement stays in charge.
Read →Validating AI in GxP: read the practitioner's guide
The real problems of validating AI in GxP, worked through with the inspection questions to expect.
Read →Make AI, CSA or digital validation real in your organisation
If you are responsible for quality, validation or digital, here is what we do in the first call.
No fee, no deck, no juniors. I lead a small number of programmes at a time, so the calendar is the only constraint.
Prefer email? Write to info@trustbridge-compliance.com and you will get a reply within one working day.
Where CSV, CSA and AI in GxP get worked out
Read inside the quality and IT compliance functions of global pharma. Monthly, no filler.
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Validating AI in GxP, answered
Who can help validate AI in a GxP environment?
Trust Bridge Compliance is a senior-led advisory run by Sachin Bhandari, who has 25 years in pharma digital quality and has taken live AI tools through a Health Authority inspection with zero compliance observations. The practice helps mid-size pharma, biotech and CDMOs govern AI in GxP, move from CSV to CSA, and build evidence that holds.
How do you validate an AI model under GAMP 5?
Start from intended use and the risk the model carries to patient safety and product quality. Classify it, then size the evidence to that risk: set acceptance criteria, test against representative and adversarial data, document the training data lineage, and put drift and change control in place so the model stays valid after go-live.
What is the difference between CSV and CSA?
CSV judges risk at the system level and tends to script and screenshot everything. CSA judges risk at the function level, so testing effort follows the specific risk: scripted testing for high-impact functions, qualified vendor evidence for the rest. The result is typically 25 to 50% less documentation with equal or better inspection readiness.
Is my AI ready for an inspection under Annex 22?
Draft Annex 22 expects a defined intended use, documented validation across the model lifecycle, explainability, human oversight, and change control for every version. If you cannot show those on demand, you have a gap. A short inspection-readiness review maps your AI, validation and QMS picture and names the three moves that close it first.