DOC ID: DIS-001 REV: A STATUS: Active CLASSIFICATION: Product Overview
GxP Compliance Intelligence Platform

An inspector's question
is not a search problem.
It's a query.

Your compliance team is sitting on tens of thousands of controlled documents — SOPs, CTDs, CAPA records, validation reports — and an expectation that any one of them can be retrieved and evidenced within hours of an unannounced inspection. This system answers the question in seconds, with the citation attached.

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document-intelligence · on-premises session
›Does our OOS SOP align with FDA's 2006 OOS guidance for laboratory investigation stages?
retrieved in 2.1s — 2 documents searched
Stage 1 (initial assessment) is fully covered. Stage 2 criteria for expanded investigation are referenced but not defined in section 4.2 — a gap an inspector would likely flag.
SOP-014 §4.2 · FDA OOS Guidance (2006), p.9
The problem

Four workflows, run by hand, under a deadline that doesn't move

Every GxP activity generates documents that must be cross-referenced, maintained, and evidenced on demand. These four consume the most time — and carry the most regulatory risk.

Pre-inspection preparation

30–90 min / question
QA managers manually Ctrl+F through SOPs and guidance documents, cross-referencing paragraph by paragraph — 50 to 100 questions per inspection.
→
A single missed gap, an SOP written against an outdated guidance, can result in a 483 observation or warning letter.

Change control assessment

~1 day / dossier
Regulatory affairs specialists manually search CTD modules across multiple PDFs to assess whether a proposed change is registered and what category applies.
→
An incorrect change category means filing the wrong variation type — triggering queries, delays, or rejection at the health authority.

Periodic SOP review

multi-week / revision
QA coordinators manually tag and search the DMS for every SOP referencing a revised guideline — for 200 risk-related SOPs after an ICH revision.
→
Failing to update SOPs when a referenced regulation changes is one of the most common — and easiest to miss at scale — inspection findings.

Regulatory query response

1–4 hrs / question
Regulatory managers read each FDA or EMA question, navigate to the relevant dossier section, and read around it for context before drafting.
→
Response windows are fixed and drafting cycles are short. Time spent locating information is time not spent strengthening the response.
The core reframe

An inspector question is no longer a search problem. It is a query. Your team types it. The system retrieves the exact document sections that answer it — with citations — in under ten seconds. The answer is ready to hand to the inspector, or drop into a gap report.

In practice

What each team asks — and what comes back

QA · Pre-inspection prep
Does our OOS SOP align with FDA's 2006 OOS guidance for laboratory investigation stages?
Retrieves the matching sections from both the SOP and the loaded guidance, surfaces the coverage gap, and produces a traceable reference — in seconds, not hours.
Regulatory affairs · Change control
Where is excipient particle size referenced in our CTD, and what post-approval category applies under EMA guidelines?
Finds every occurrence across all CTD modules and surfaces the relevant regulation. A full-day assessment becomes a one-hour review.
QA · Periodic SOP review
Which of our SOPs reference ICH Q9, and what in the 2023 revision isn't addressed yet?
Identifies every affected document and flags the gaps — a multi-week project becomes a structured report generated in hours.
Regulatory · Query response
[Pastes the FDA question directly]
Retrieves the relevant dossier sections, surfaces what's already documented, and identifies what's missing — a head start on every response.
Built for your regulatory environment

Not adapted from a generic AI tool

Every architectural decision was made with GxP requirements and data sovereignty in mind — because a validated computerised system doesn't get to inherit someone else's assumptions.

[ infra.location ]

Fully on-premises

No document, query, or response ever leaves your infrastructure. No cloud dependency, no external API calls — the data sovereignty most pharma legal and IT teams require before approving an AI tool for regulatory documents.

[ audit.trail ]

21 CFR Part 11 & Annex 11 ready

Every query and response is logged with timestamps and user attribution. The audit trail isn't bolted on afterward — it's part of the core architecture. An IQ/OQ/PQ documentation package is available as a formal add-on.

[ citation.required ]

Source attribution on every answer

The system cannot generate an answer without citing the exact document and section it came from. No hallucinations, no unsupported claims — a compliance officer can hand every response directly to an inspector.

[ stack.open_source ]

No vendor lock-in

Built entirely on proven open-source components — LLaMA 3, ChromaDB, FastAPI. No SaaS subscription, no ongoing API dependency. The model version and update cadence stay fully under your control.

Cortellis tells you what the regulations say. IQVIA tells you what the regulators have done.

This system tells you whether your documents comply with them.

That gap — between knowing the rules and knowing whether you follow them — is what the Document Intelligence System closes. On your infrastructure. Against your documents. Traceable to your inspector.

CHF 500k–5Mto remediate a single FDA 483 observation
< 10 secto retrieve a cited answer to an inspector's question
1 findingprevented pays for the system — it's designed to prevent many
Get started

See it answer your own question

Bring an SOP and a guidance document. We'll show you the retrieval, the gap, and the citation — on your infrastructure, with your documents.

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Or write directly: lr@methodos.ch