Your AI validation document set. Already written.
The book explains the thinking. The Practitioner Pack is that thinking finished as working documents: 50 templates, 13 SOPs with 10 checklist and RACI companions, and 19 quick reference guides, every one carrying its worked example, licensed to your organisation and watermarked in your name. Your team adapts instead of authoring.
One licence covers your whole organisation · no per-user pricing · the documents you adapt stay yours
Written and maintained by Sachin Bhandari, author of Validating AI in GxP, draft Annex 22 industry reviewer, Global GAMP SteerCo. 25+ years in pharma digital quality.
The full lifecycle, as documents your QMS can hold
93 working documents, in five sets
Intake and risk tiering, intended use, data governance, testing and acceptance, explainability, monitoring and drift, retraining, incidents, supplier oversight, generative AI, inspection readiness. Every code matches the book and the course, so your team moves between them without translation.
Templates
T01 to T34 with companion worksheets: the AI system inventory, validation master plan skeleton, model card, test data plan, PCCP, risk register, evidence pack index and the rest. Editable Word, a worked example inline in every one.
SOPs
SOP-00 to SOP-12: the lifecycle umbrella, retraining and deployment, monitoring and drift response, risk assessment, retirement, supplier oversight, intake, incidents, periodic review, generative AI authorisation, data governance, competency, and security. The first five carry an operator checklist and a RACI matrix of their own.
Checklist and RACI companions
Two per SOP for SOP-01 to SOP-05, the five your team runs most often: an operator checklist that turns the procedure into steps somebody can follow at the bench, and a RACI matrix that names who does the work and who signs it off.
Quick reference guides
One-page decision aids your teams keep at their desks: the tier decision in four questions, the 12-section evidence pack, the drift response ladder, inspection readiness in 20 questions, the LLM and GenAI envelope, and more.
Regulatory position note
RPN-01, the state of the rules this pack is built on, reissued quarterly or on any change to a cited instrument. It carries the verification date on its face, so your own position paper cites something current rather than something from the year it was written.
Plus a how-to-use guide that maps every document to the book chapter behind it, so a new team member can find the reasoning in one step.
What would it take to write this yourself?
Months of a senior practitioner's time, and most of it spent on the documents nobody enjoys writing. With the pack, your team's first task is adapting to your systems and risk appetite, not authoring from a blank page.
The people doing this work rate the thinking behind it
It gave me a practical and inspection ready framework for validating AI systems in GxP environments. The lifecycle approach, governance model and templates can be applied immediately.
Detailed understanding of the concept which helps in working on AI validation. This is a hand book that can be used for quick references and will help in training fellow colleagues.
Reader feedback on Validating AI in GxP, shared with permission. The pack is the working layer behind the same approach.
Take the documents, or take the documents with the author
Both are a one-time organisation licence in USD. Most teams take the working sessions, because the hard part is never the template, it is the judgement call inside it.
Practitioner Pack
- All 93 working documents: 50 templates, 13 SOPs, 10 checklist and RACI companions, 19 QRGs and the regulatory position note, editable Word and PDF
- Worked examples inline, how-to-use guide included
- Organisation-wide internal use, unlimited users
- Your organisation's name on every page
- One version update included
Pack + Working Sessions
- Everything in the Practitioner Pack
- 15 hours of remote working sessions with Sachin Bhandari
- Adapt the templates to your systems and risk appetite, together
- Your adapted documents reviewed before they go live
- Direct answers on your hardest tiering and evidence questions
Prefer to talk it through before you buy? Book a 30-minute call with Sachin →
Here is the licence in plain words
Your licence covers internal use across one organisation, with no user limit. The pack cannot be resold, shared outside your organisation, or built into a commercial product or client deliverable. Every delivered file carries your organisation's name in the footer, and one version update is included, so your set does not go stale the day the rules move.
Consultancies and software vendors: this licence is for use inside one company's own QMS. For client work or product use, write to us and we will discuss a separate arrangement.
How buying works
Tell us who the licence is for, and the invoice comes back the same working day.
You get your invoice the same day
Give us the licensee details and we raise a TrustBridge invoice against them. It reaches your inbox within minutes, with the bank details your finance team needs.
Pay by bank transfer
Settle it in USD by ACH inside the United States, or by SWIFT from anywhere else. Quote the invoice number as the reference and we match it to your licence automatically.
Watermarked delivery
Once the transfer clears, your build is generated fresh, stamped with your organisation's name on every page, and delivered within one working day.
Licence your organisation
Your details name the licence and appear on the watermark and the invoice. We raise the invoice against them and send it straight back to you.
Questions I get asked about the pack
How is this different from the templates in the book?
The book carries 28 template structures, a mix of worked examples and skeletons, because their job there is to teach the approach. The pack is the full working set of 93 documents: 50 fully developed templates with worked examples inline, 13 complete SOPs with 10 checklist and RACI companions for the first five, 19 quick reference guides and the quarterly regulatory position note, all editable and aligned to the same codes.
What happens after the included update?
The documents are yours to keep either way. The included update covers the next release of the pack. Beyond that, update arrangements are offered to existing licensees first.
How do we pay?
By bank transfer, in USD, against a TrustBridge invoice. Ask for the invoice on this page and it arrives within minutes, carrying the account details and a reference to quote. Inside the United States it settles by ACH, and from anywhere else by SWIFT.
Quoting the invoice number as the payment reference is what lets us match your transfer to your licence. If you need a purchase order route, a vendor form completing, or an INR invoice from India, book a call and we will set it up.
Can we see a sample before deciding?
Yes. Write to info@trustbridge-compliance.com or book a call and we will send sample pages or walk your team through the set.
Does training pair with the pack?
Yes. The in-house programmes on the training page teach the thinking the pack implements, and an 8-hour course on the pack itself can be scoped with your licence. Mention it in the form.
We are a consultancy or a software vendor. Can we buy it?
Not on this page. The licence here covers one company's internal use. For client-facing or product use, write to us and we will discuss a separate arrangement.