How we draw the line.
Every tool in a GMP environment must answer one question before any other: what happens to the official record? OgmaQ answers it by design. The operational work lives here. The record of record stays in your validated QMS. This page is that line, drawn once, so every compliance conversation starts answered.
What lives where
Not a workaround: an architecture. Each side does what it is built and governed to do.
OgmaQ is operational escalation support. It is not a validated GMP system of record by default and makes no 21 CFR Part 11 / EU Annex 11 compliance claim.
One reference, not an integration
OgmaQ stores the QMS record id alongside the escalation — a pointer, never a copy. It does not mirror, import or rewrite the system of record.
Illustrative demo data. The official record keeps its home; OgmaQ keeps the operational work pointed at it.
Print. Sign on paper. File in the QMS.
OgmaQ deliberately builds no electronic-signature capture. Where regulation wants a signature, the record leaves OgmaQ on paper.
Print the record
The interview record prints with names pre-filled where the record knows them — and the signature and date lines blank, for handwriting.
Sign outside OgmaQ
Signatures are applied on paper. OgmaQ does not capture, witness, verify or authenticate them — the export is not an electronic-signature record, by design.
File the original
The signed original is filed in your validated QMS under your own procedures. A scan can sit with the escalation as evidence, next to the QMS reference.
The line is the feature
The validation burden stays where it already lives
Your QMS is validated and your procedures around it are established. OgmaQ adds an operational layer for the work between records without asking you to re-validate that work.
One answer to the record question
"Where is the official record?" always has the same answer: in the QMS, where it has always been. OgmaQ holds the operational trail that led there — and the reference.
Adoption without a migration
Nothing moves out of the QMS and no integration project stands between you and starting. OgmaQ works alongside what you have, from the first record.
The questions we expect
Does OgmaQ replace our QMS?
No — deliberately. OgmaQ is operational escalation support that works alongside your validated QMS. Official GMP records — deviations of record, CAPAs, batch disposition, signed documents — remain in the QMS under your own procedures. OgmaQ stores the operational work around them, plus a reference to the QMS record id.
Is OgmaQ a validated system? Does it claim Part 11 / Annex 11 compliance?
No. OgmaQ is not a validated GMP system of record by default and makes no 21 CFR Part 11 / EU Annex 11 compliance claim. That is stated on every page of this site, and the product is designed around it — when a signature is required, the record is printed and signed on paper, and the original is filed in your validated QMS.
Why is this boundary a good thing?
Because the validation burden stays where it already lives. OgmaQ adds an operational layer for the work between records — triage, containment, actions, interviews, closure tracking — without asking you to re-validate that work or migrate official records anywhere.
Bring this page to your QA review.
The boundary above is how OgmaQ is built. If your quality team has a question it doesn't answer, we want to hear it.
Or email hello@ogmaq.com directly.