Software for the work between systems.
Ogma OS builds focused software for regulated operations — helping teams turn disconnected observations, decisions and follow-up into structured operational workflows.
Enterprise systems capture records. Operations still happen between them.
Established manufacturers already run validated systems of record. What those systems rarely hold is the work that produced the record — the observation on the floor, the context someone had to go and find, the reasoning behind a call, and everything that had to happen next.
Illustrative examples of operational work.
One excursion, reconstructed — illustrative
Night shift calls in a cold-room alarm. The details live in one operator's memory of the call.
The outgoing lead briefs the incoming one at the door — what was checked, what to watch. Nothing is written down.
A thread starts: four people, two forwards. The decision is at the bottom; the reasoning is somewhere in the middle.
A row appears in the tracking sheet — owner and status, none of the why.
The same alarm fires again. The context has left with the people who had it, and the reconstruction starts over.
We build for that layer.
Ogma OS creates focused software for operational workflows that sit between people and established enterprise systems. We aim to preserve context, make decisions visible and help teams coordinate what happens next — without trying to replace the systems of record they already depend on.
A record still belongs in the customer's validated system. What we build is the working layer around it: where the observation is captured, the context is attached, the decision is made and the follow-up is owned.
Illustrative example. The systems named on this page are the customer's own — Ogma OS does not connect to them.
01 / Products
OgmaQ
Operational quality escalation — one structured workflow from the first observation to a closed record, for quality and manufacturing teams in pharma and biotech.
Screenshot of OgmaQ running on fictional demonstration data. The QMS record column is the point: OgmaQ references the customer's own system of record rather than replacing it.
Visit OgmaQ — opens ogmaq.com, the OgmaQ product site
OgmaQ is an operational prototype. It is not a validated GMP system of record and makes no 21 CFR Part 11 or EU Annex 11 compliance claim — official GMP records stay in the customer's validated QMS.
How we build.
Focused, not bloated
Solve the operational problem in front of the team. Don't recreate the enterprise suite around it, and don't add a module because the category expects one.
In practice — when regulation wants ink, OgmaQ prints the interview record for signature on paper and the original is filed in the customer's QMS. It does not capture or verify signatures, by design.
Human context matters
Preserve the reasoning and the circumstances around a decision, not only its final state. The record of what was decided is worth much less than the record of why.
In practice — OgmaQ runs structured interviews on the record, so who saw what — and why the call was made — is captured while people still remember it.
Fit into existing systems
Build alongside the validated systems a site already depends on. Referencing a system of record is almost always better than demanding it be replaced.
In practice — OgmaQ stores references to QMS record ids alongside its own records. It never mirrors, imports or rewrites the system of record.
Designed with practitioners
Build around how quality and manufacturing teams actually do the work — on a shift, under time pressure, with the information they really have.
In practice — triage questions, suggested severity and closure rules in OgmaQ are configurable per site, because no two plants run the same process.
Ogma OS
We build operational software for regulated industries, starting with pharmaceutical and biotechnology manufacturing.
Our first product, OgmaQ, focuses on operational quality escalation and the work around it — triage, containment, decisions, structured interviews and handover between shifts and functions.
Ogma OS is an early-stage company. We would rather be clear about that than imply a scale we do not have.
The name is the thesis. Ogma, in Irish tradition the patron of eloquence, is credited with Ogham — the earliest Irish script. Writing things down so they survive.
