Software that passes the audit and the business review.
We turn regulated processes — document control, quality, environmental monitoring — into systems that operators actually want to use and auditors can trace line by line.
- Reply within 1 business day
- NDA on request
- GMP · GDP · 21 CFR Part 11
- 01 Draft submitted
- 02 Validation check
- 03 Qualified person sign-off
Trusted by regulated teams across the EU
Four things we do properly, in regulated environments.
Business process automation
Procurement, warehouse, HR and training flows turned into one traceable, paperless system.
Explore 02Custom software development
Product teams and integrations built to be validated, documented and handed over — not just shipped.
Explore 03Quality & compliance systems
Document control, deviations, CAPA and OOS with a complete, exportable audit trail.
Explore 04Environmental monitoring
24/7 control of storage and production conditions with alerts, trends and audit-ready reports.
ExploreA document system 1 200 people actually use.
A top-10 European pharma manufacturer ran document control on shared drives and paper copies. We replaced it with a validated platform covering creation, review, approval and archiving — with training and certification tied to the same records.
We only claim the sectors we can prove.
Validation is part of delivery, not a phase after it.
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01
Discovery with the SOPs on the table
We read the procedures the system has to serve and turn them into user stories — not the other way round.
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02
Traceable build
Every requirement carries an ID through design, code, test and release notes, so the trace matrix is a build artefact.
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03
Validation and handover
IQ/OQ protocols, audit trail review and admin training ship with the release, not months later.
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04
Support under change control
Fixes and improvements follow the same change control as the original release, with the same evidence.
Bring us the process that keeps failing the audit.
Send a short description of the system and the standard it has to satisfy. We reply with a scope, a timeline and the validation approach — before any contract.