Audit-ready every day. Response-ready in hours.
Don't scramble before an audit. Quality & Compliance continuously surfaces gaps against current expectations, supports mock audits, and turns observations into structured, evidence-linked responses — with your experts reviewing every word.
Built for
An inspection is a test you study for all year —
or cram for in a panic.
Audit readiness decays quietly: expectations move, documents drift, evidence scatters. And when an observation lands, the clock starts — a defensible response is due in days, not weeks.
Ready before the audit. Fast after it.
Two jobs, one module: keep the site inspection-ready on an ordinary Tuesday, and turn observations into defensible responses when it counts.
Continuous gap detection
Surface gaps against current regulatory expectations on an ordinary day — before an auditor finds them on a bad one.
Mock audit & readiness support
Run mock-audit exercises and readiness reviews so the inspector’s questions are ones you’ve already answered.
Data integrity (ALCOA+) checks
Check records and practices against ALCOA+ expectations — attributable, legible, contemporaneous, original, accurate.
Observation → structured response
Parse a 483 or audit observation into a structured draft response with clear commitments — in hours, not weeks.
Evidence linked to every commitment
Each commitment ties to its supporting evidence, so the response is defensible line by line.
Expert sign-off, required
Your Quality and Regulatory leads review, edit, and own every response. The AI drafts; your experts decide what goes to the agency.
From expectation to evidence — and observation to response
Ingest
Bring in your procedures, records, and the expectations that apply to your site — or a fresh observation.
AI surfaces & drafts
Gaps surfaced and prioritized; responses drafted with commitments and evidence linked.
Experts review & decide
Your qualified reviewers challenge, edit, and approve. Nothing goes out without a human decision.
Inspection-ready
A maintained readiness picture — and submission-ready responses when you need them.
Fewer surprises. Faster responses. Calmer rooms.
*Time savings of 60–70% observed on targeted workflows, depending on adoption and process fit, validated in proof-of-concept.
Straight answers on Quality & Compliance
Can it write our 483 response for us?
It drafts a structured, evidence-linked response — the narrative, commitments, and supporting references — in hours. Your Regulatory and Quality leads then review, edit, and own every word before anything goes to an agency. The approach is published in ISPE Pharmaceutical Engineering.
What does “continuous audit readiness” actually mean?
Instead of a pre-audit scramble, gaps are surfaced against current expectations on an ongoing basis — supported by mock-audit exercises — so readiness is a maintained state, not an annual project.
Is our data used to train your models?
No. Your documents and data are never used to train shared or third-party models. Details on data handling, residency, and access controls are on the Trust & Security page.
How do we start?
A common start is a time-boxed pilot on a recent observation or a mock-audit exercise — so you see the quality of the output on your own material before any broader commitment. Talk to us and we’ll propose a pilot.
Bring a recent observation
We’ll show you a structured, evidence-linked draft response on your own material — with your expert in control the whole way.