Optomiq streamlines the entire quality audit lifecycle — planning, document requests, on-site notes and reporting — and matches evidence against the regulations that matter.
From the first document request to the final signed report — and every observation in between.
Plan scope, build document request lists, set the agenda and coordinate logistics — all in one place, with team review built in.
Every submitted document is checked against ISO 13485, EU GMP, FDA 21 CFR and ICH guidance to surface gaps and compliance issues automatically.
Turn on-site notes into a structured draft report — graded findings, regulatory citations and an executive summary ready for review.
A guided path that mirrors how experienced auditors actually work.
Create the audit, define scope and regulations, set the agenda and logistics.
Send document requests to the auditee and track every submission as it arrives.
Capture observations on-site with AI-suggested severity and regulatory references.
Generate the draft report, route it for review and manage auditee responses.
A closed system per company — no cross-contamination of data between audits. Designed from the ground up for the credibility biotech and pharma demand.
Log In to the demo