Not a maturity score — a decision on every AI use case. Six areas where computerized-system inspections repeatedly find gaps: five long established in FDA's data-integrity expectations under 21 CFR 211.68 and Part 11, and the one now arriving — AI. You find out where each system and use case stands, what to fix first, and what it will take, before an inspector tells you instead.
Six areas. Every system and AI use case you nominate is scored against each one, with the evidence behind the score.
| Area | The question answered | |
|---|---|---|
| 01 | Access & attribution | Can every GxP action be traced to a unique person — or do shared logins exist? |
| 02 | Audit trails | Are they on, complete, reviewed, and reconstructable? |
| 03 | Validation state | Which systems are making GxP decisions without defensible validation? |
| 04 | Record integrity | Can records be altered or backdated without a trace? |
| 05 | Backup & retention | Can data be deleted or overwritten without detection? |
| 06 | AI governance | Where is AI influencing GxP decisions — and is it controlled? |
Five artifacts. Yours to keep and act on, whether or not you ever use our platform.
Every AI use case gets a decision — proceed, proceed with controls, validate, or refuse — with the GxP impact and required assurance behind it.
Every system scored red / amber / green against the six areas, with the evidence behind each score.
Each gap rated by inspection risk and effort to close, so the sequence is obvious rather than debated.
What to fix first, who owns it, and what "done" looks like for each item.
A deck your leadership can act on — written so you don't have to translate it first.
Fixed scope, fixed fee, fixed end date.
Kickoff, evidence review and interviews, then the readout. Roughly 4–6 hours of your team's time in total.
Fixed fee. No hourly billing, no scope creep, no $400/hr surprise at the end of the month.
20+ years across big and mid pharma. 10,000+ professionals trained in modern CSA. Not a junior on a rate card.
Three steps, and each one credits toward the next — so nothing is paid for twice. Not ready to talk yet? Screen one AI use case free in 30 seconds →
One system, one problem, worked live with your team. You get a one-page findings memo and the three actions worth taking first.
The full six-area review: a decision on every AI use case, scorecard, gap register, 90-day plan, and an executive readout — closing with a working session where the first three actions get agreed in the room.
For teams whose remediation plan is bigger than their capacity. I own the plan with you — reviews, risk calls, inspection prep — without adding headcount.
You get the scorecard and the plan whether or not you ever use our platform. If the remediation turns out to be bigger than your team's capacity, we can run it with you — but that's a separate conversation, held after you have the findings in hand.