What the toolkit gives you
Most quality organizations have an AI policy. Fewer can answer that question for a named workflow.
In between sits work no one registered: a summarization step added to an investigation, a consumer tool a reviewer opened without approval, or a vendor feature enabled during a system upgrade.
A policy states a position. It does not record a decision about a specific workflow, and that decision is what has to hold up later.
The public reference copies use worked examples. They let quality, process, system, and governance leaders review the method before licensing editable implementation files or requesting support. The added print guide is a supplemental visual, not an operating record. Download the eight-page Letter print guide.
Discover and assign ownership
AI Use Inventory
Captures the actual task, system, users, data and records involved, downstream decision, current status, and named owners, including unapproved use that would otherwise remain invisible.
Record each gate decision
Gate Decision Record
Records what was reviewed, which evidence supports the decision, the measured baseline and reviewer-burden limit, who is accountable, and which finding or change would trigger reconsideration.
Evaluate the workflow
Workflow Evaluation Scoring Sheet
Structures representative-case evaluation, measured baseline, reviewer-burden limit, monitoring rule, critical-failure handling, protected-holdout results, and the resulting gate recommendation.
Adjudication Protocol
Defines the critical-omission classification method, independent adjudicators, calibration collection, reliability criterion, method freeze, protected holdout, and documented resolution process.
Authorize, monitor, and review
AI Authorization Register
Aggregates defined fields from individual Gate Decision Records, including the omission bound, reliability gate, reviewer-burden limit, and current burden against it, so leaders can see authorization status, authority levels, review dates, open risks, changes, incidents, and management escalations without replacing controlled source records.
Independent Effectiveness Review Record
Structures a risk-based, independent test of whether authorization boundaries, monitoring, adjudication integrity, reviewer-burden controls, stop triggers, retained evidence, and corrective actions are operating effectively.
Put the sequence to work
User Guide
Explains the connected control sequence, implementation boundary, artifact crosswalk, and the required sequence of baseline measurement, pre-set burden limits, calibration, method freeze, and protected-holdout evaluation.
Role Quick-Start Cards
Gives process owners, system owners, data owners, quality owners, reviewers, evaluation owners, independent reviewers, and management reviewers a role-specific starting point.
Editable implementation toolkit
For teams ready to adapt the operating records locally, the license includes editable blank masters for the inventory, Gate Decision Record, scoring sheet, AI Authorization Register, Independent Effectiveness Review Record, User Guide, Role Quick-Start Cards, and Adjudication Protocol.
- Editable formats: Excel (.xlsx) for the AI Use Inventory, Workflow Evaluation Scoring Sheet, and AI Authorization Register; Word (.docx) for the Gate Decision Record, Independent Effectiveness Review Record, User Guide, Role Quick-Start Cards, Adjudication Protocol, companion white paper, and Release Notes / Verification Summary
- Internal-use license for one organization
- Records aligned to the six-stage authorization cycle
- Local document control, approval, protection, and release remain with your organization
Versions and updates
The license is perpetual for version 4.2. The companion white paper and Toolkit version 4.2 are informed by and cite the publicly available draft of EU GMP Annex 22. GxP Frame will make available one no-charge update after final Annex 22 is published, reflecting changes that the final text makes material to the method or operating records.
Updates are delivered as optional packages with a change summary, not as replacements. Once you have adapted and approved these records inside your quality system, adopting a new version is your change-control decision, not ours. The change summary identifies what moved, what is consequential, and what requires no action, so you can decide whether the update warrants a revision.
Except for that Annex 22 transition update, later Toolkit versions are not included. Existing licensees may upgrade to the current version at any time for 40% of the then-current list price, currently $1,300 as of the date of this policy. The upgrade fee applies once per upgrade regardless of how many versions were published since your purchase.
License review and purchasing details are confirmed before editable blank masters are issued.
Stage 0 AI Use Inventory and Ownership Review
For a QA or governance leader who needs a practical starting point, this engagement focuses on one selected operating area. It identifies actual AI-supported work, including known unapproved use, and establishes the ownership and disposition needed before deeper qualification or implementation work begins.
You receive
- A facilitated Stage 0 working session with the relevant quality, process, system, and data representatives
- A populated draft AI Use Inventory for the selected operating area, based on information your organization provides
- An ownership map identifying unresolved process, system, data, and quality-accountability gaps
- A prioritized disposition list: register, contain, prohibit, assign ownership, or advance for Stage 1 assessment
- A leadership readout with immediate actions, evidence gaps, and recommended next decisions
Scope boundary
This is an inventory-and-ownership engagement, not system validation, supplier qualification, legal advice, a Part 11 determination, or authorization for routine use. Any later evaluation, implementation, remediation, or controlled-document work requires a separate written scope and approval.
The starting price applies to one selected operating area at one site. Participant count, workflow inventory volume, source readiness, schedule, and final commercial terms are confirmed in a written work order before work begins.
Start Monday
Inventory actual AI use, not just approved vendors. For each use, identify the task, source systems, records and data involved, users, output, downstream decision, ability to act, and the process, system, data, and quality owners. Do not treat discovery as authorization: use the inventory to decide what must be contained, prohibited, assigned, or evaluated next.