AI Adoption & Governance Advisory
Pharma is at an inflection point. AI is reshaping discovery, manufacturing, quality, engineering, supply chain and regulatory submissions — and Annex 11, the draft Annex 22 and the EU AI Act converge on one dossier, with the AI Act's high-risk duties due from December 2027. Whatever your size or business model, the ValiCore ADVISORS AI Compass - our framework for AI governance guides the adoption end-to-end — every AI and digital system you run or plan, governed through its whole lifecycle, validated at the right point, mapped to your regulatory obligations and business priorities, inspection-ready from day one.
You build AI-driven systems for pharma — whether the AI sits in production, lab, quality or supply-chain software, in an analytics platform or in a pure AI product?
We validate the product once — the evidence your customers' inspectors will ask for. It feeds their qualification; it never replaces it.
Why pharma needs structured AI governance - with compliance by design.
Generative AI, computer vision, predictive analytics and agentic workflows promise material gains across pharma operations — yet many programmes stall between pilot and shop floor, and a rulebook that tightens every year leaves no room to bolt compliance on at the end. And AI no longer arrives only as a project you chose: it arrives inside the systems you already run, one vendor release at a time.
1
Use-cases without process truth
Ideas are sourced from vendor demos, not from the actual GMP process map; value, criticality and feasibility cannot be defended at a Quality steering committee.
2
Readiness blind spots
Models are launched before data, integration, identity, time-sync, qualification and people-readiness exist — leading to integrity gaps and compliance debt.
3
Regulatory afterthought
Draft Annex 22, Annex 11, Annex 15, GAMP 5, ICH Q9(R1), FDA CSA, EU AI Act and 21 CFR Part 11 are bolted on at the end, instead of shaping intended use, risk classification and validation rigor up front.
4
AI you never chose
Your eQMS, LIMS, MES, automation system or any other computerised system gained AI features in a routine vendor update. The system still counts as validated, the release note was skimmed, and no one registered the model, its intended use or who
oversees it. The obligations attach to the system as you use it, not to how the AI got there.
Every engagement starts with a dialogue.
Consultancy is a conversation. Every partner arrives with a different question — an upcoming inspection, a single vendor under contract, a board asking for an AI strategy, a process owner with a use-case in mind. We listen first, then shape the work to match.
1
Listen
A discovery call with the team closest to the decision — QA lead, IT, the sponsor. We want to understand the actual question, the timeline, the constraint, the budget reality.
2
Sketch
We come back with two or three scoped options — what we'd do, who'd be on the team, how long, what it costs, what you'd own at the end. You pick one, mix two, or send us back to the drawing board. Nothing starts until the scope is signed.
3
Co-design
Before the first workshop, we agree the people, the owners, the KPIs, the stage gates, the hand-over plan. Everything in writing. Quality has a veto from day one — not bolted on at the end.
Seven phases. One governance layer across them.
Governance is built along the way — six elements, eacha template, a policy or a register your own team maintains — and validation, in phase seven, fills the record they define. For AI you already run, validated or not, the same six elements are laid over the evidence you have: registered, classified, reviewed on a cadence. Most engagements pick up midway — you have a use case chosen, a vendor selected, or a dossier half-written. The earlier steps become inputs, done by your team, by a previous consultant, or absorbed from the vendor's own validation plan. The dialogue tells us where you enter.
What you get
Scope your engagement from these outcomes — take what your case needs. We work through them at your side; building, installing and operating your AI stays with your team and your vendors.
Twelve checkpoints, one record for each.
The AI Compass is designed inside the pharma rulebook from day one. It absorbs the EU AI Act, the draft Annex 22, Annex 11, FDA Computer Software Assurance, ISPE GAMP 5 and the EMA/FDA AI Principles into one Inspection-Ready Dossier your QA team owns.
The cockpit, in plain words
A pre-flight checklist for AI on your shop floor
The AI Compass is the methodology; the Cockpit is the workbook it lives in. This section shows the workbook.
One instrument per area an inspector cares about — purpose, risk, data, performance, change, vendor, human oversight, privacy. Every reading sits on a named, signed artefact, and together they roll up into one readiness rating, Initial to Optimised. It all lives in a structured
workbook — SOP, audit trail, snapshot hashes, qualification pack — or in the registers of your own QMS and IT stack, and renders in whichever BI tool or wiki you already use.
What your operation gets out of it
The systems create the value on your shop floor. The governance keeps it there — spend that happens once, approvals against agreed standards, a release capability that stays intact.
Three ways to begin
Pick the entry point that matches today's question — and switch later if the question changes.
1
Targeted workshop · 1–3 days
One focused question, a decision-grade answer. "Which of our processes would AI pay back first?" "Should we qualify this vendor?" "Is our visual-inspection AI Annex 22 ready?" "Our LIMS just gained AI features — what does that change for our validated state?" "What will the inspector ask about the AI we already run?" A senior consultant on site; the workshop stands on its own.
The classic opener. An AI readiness assessment of your own operation — the audit-grade checklist run diagnostically against the AI you already have.
You walk away with
- A decision-grade answer to one real question
- A first read on where AI pays off in your operation
- A gap map with named owners
2
Compass Programme · co-designed scope
The phases that fit your case, in your order, entered where you stand. A use-case already chosen, a vendor already selected, a dossier half-written — the earlier phases become inputs and we start at the open question. Where Scan and Discover are in scope, they happen on the shop floor with your Manufacturing, Quality, Engineering and Supply Chain teams. From a single product line to a multi-site programme.
Every phase ends in your hands. Each phase closes with a deliverable your sponsor signs, filed in your QMS, usable whether or not the next phase follows.
You walk away with
- The signed deliverables of every phase you entered — a dated edition, filed in your QMS.
- A use-case pipeline your operations chose, sequenced by value and readiness, and the vendors qualified to deliver it.
- The inspection-ready dossier and a signed Cockpit — in the workbook or in your own QMS and read by the BI tool your operation already uses.
- Trained teams and qualified caretakers before we exit.
3
Compass Steer · ongoing
For teams already running the Cockpit: the recurring governance cycle at the cadence your classification sets — quarterly read-out, drift monitoring on the systems your production depends on, vendor re-qualification, periodic review.
Your team owns operations. We sit on the steering committee to keep the Cockpit honest and the roadmap moving.
You walk away with
- Drift caught before the line feels it
- Regulatory change absorbed as versioned updates
- Senior counsel — without adding headcount
Explore a strategic partnership
You build, integrate or operate AI for pharma; we make it run in GxP — classification, validation, the inspection-ready dossier. Upstream, we scan operations for new use-cases and guide vendor selection, preparing the ground your solutions land on. Your delivery, our governance — one offer that holds up in an inspection. Let's start the partnership with a conversation.
