Things proven, by construction.
Probata is a quality management system for cGMP and GxP manufacturers — sterile compounders, contract manufacturers, small biotech. It turns the diligent work your team is already doing into provable, inspection-ready evidence — as a side effect, not as a separate compliance chore.
Compliance that's a property of the system, not a task on top of it.
The Master Batch Record is a projection — every executed step is an immutable event with a Part 11 audit trail attached. Reconstruct any record at any historical point. No more reconciling deviation logs against the binder a week before audit.
The release reviewer drafts a deviation summary, flags exceptions against your URS, and surfaces the supporting evidence inline. A qualified human signs. The AI never signs anything.
IQ / OQ / PQ artefacts are produced by the system as you configure it — not a separate Word-doc tower of Babel. Categorization is explicit; functional risk and supplier assessment travel with each component.
Built first for sterile compounding. Generalizes from there.
The anchor customer is Onclave Health, a 503B sterile compounding facility. The shape of their problem — high-stakes manufacturing, real-time release decisions, and a non-negotiable audit trail — generalizes cleanly to small biotech, ATMP / cell therapy labs, contract manufacturers, and outsourcing facilities of any kind.
If you have an FDA-registered facility, a quality unit that's drowning in PDFs, and a feeling that the audit-prep sprint shouldn't be a month-long event — we should talk.
- 503B outsourcing facilities
- 503A sterile compounding pharmacies
- Small biotech / pre-commercial CMC
- ATMP & cell therapy labs
- Contract manufacturers (small molecule)
- Repackagers & relabelers
Cosmetic brand owner navigating MoCRA?
Probata Beauty is our sub-brand for cosmetic compliance under the Modernization of Cosmetics Regulation Act of 2022. Free tools for the §612 small-business exemption check, FDA facility registration, adverse-event tracking, and label review.
Visit Probata BeautyWe're early and we read every email.
The product is in the field at our anchor customer today and onboarding more deliberately. If your quality unit is stuck, or you're standing one up from scratch, write to a founder.