Quality Management for pharma and biotech companies that deserve better tools.
A compliant, lightweight, and affordable QMS — built for the teams that run lean but operate under EMA Annex 11, 21 CFR Part 11, GAMP 5, and COFEPRIS. Audits, Deviations, Change Control, CAPA, Complaints and Document Management are running today.
☁ Cloud-hosted · No installation · No servers · No IT department needed
The product
Existing QMS platforms are built for large enterprises. Hemeralis® is built for the teams that move fast and need to stay compliant.
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
EMA Annex 11, 21 CFR Part 11, GAMP 5, and COFEPRIS are first-class design requirements — not add-ons bolted on after the fact.
Lightweight & fast
No month-long implementation projects. No army of consultants. Up and running in days, not quarters.
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.
Modules
Deviations, Change Control, Audits, CAPA, Complaints and Document Management — the quality processes you can run today.
See the modules →Features
Electronic signatures, a tamper-evident audit trail, parallel approvals, locked statuses and a compliance export an inspector can read.
See the features →Where we are launching
Europe
EMA · Annex 11 · GDPR-ready
United States
21 CFR Part 11 · FDA-ready
México
COFEPRIS-ready
Get in touch
Tell us which quality system you use today and what you need from it. Every message is read by the person who built Hemeralis®.
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