Document control software built for ISO 15189 laboratories
Number, review, approve and e-sign SOPs with full version history — then turn your forms and logs into live records your whole team can trust.
Controlled documents
Automatic numbering, locked versions, a full revision history, superseding of obsolete versions and periodic review tracking — the core of ISO 15189 clause 8.3.
Electronic signatures
Each signature needs the signer's password again, is recorded in a signature manifest and is protected by a SHA-256 integrity hash. This meets the expectations of ISO 15189 for authorised approval.
Live forms and logs
125 form, log and QC sheet templates become live records: automatic calculations, out-of-range flags as values are entered, a correction trail with reasons, and gap alerts on daily logs.
Controlled library and assessor access
One library of current, effective documents. Read-and-understood acknowledgements are recorded per version, and assessors get time-limited, read-only access.
Paper-exact printing
Controlled copies print exactly as they appear on screen, in A4, Letter, Legal, A5 and A3, as Word or PDF, with cover page, revision history and signature manifest.
Your branding
Upload your letterhead, logo and colours once. Every controlled copy, on every paper size, carries them.
Standards and languages
Map documents to ISO 15189:2022, CLSI quality system essentials, WHO SLIPTA, ISO/IEC 17025 and ISO 15190, with crosswalk links. Write documents in English, French, Portuguese or Spanish.
- Append-only audit trail of every change
- Role-based access for authors, reviewers, quality managers and assessors
- Clause coverage and readiness dashboards across all your standards