Quality Management System for Pharmaceutical & Biotech Compliance, without the complexity.

Cloud-native. Nothing to install.

Log in from any browser. No software to install, no servers to procure, no IT department required. Your QMS is ready the moment you are.

Built compliant

EU GMP Annex 11, 21 CFR Part 11, GAMP 5, and COFEPRIS are first-class design requirements — not add-ons bolted on after the fact.

Ready to use, out of the box

Standard workflows, already configured, with electronic signatures and approvals in place. No implementation project. Up and running in days, not quarters.

Self-service

Your System Administrator invites users, assigns roles and maintains picklists without waiting for us. Your team learns from our user and administrator manuals and our training videos.

Vendor-operated

We manage deployments, migrations, and upgrades on your behalf. Your team focuses on quality, not on infrastructure.

End-to-end quality workflows

Deviations, Change Control, Audits, CAPA, Complaints and Document Management — all connected, all in one place.

Multilingual by design

English, Spanish, German, French and Dutch are first-class languages throughout the platform — not an afterthought.