eQMS
One place for controlled documents, training, products and lots, and quality events - so quality work stays linked and ready when an auditor asks.
How it works
Obsevia eQMS is an electronic quality management system built for medical device and IVD manufacturers. Quality teams manage SOPs and technical file documents, assign and track training, open and close CAPAs and complaints, and keep product and lot context next to the records that belong with them. An in-product assistant can look up live records and draft proposals; people still approve anything that writes to the system of record.
- Controlled documents with revisions, scope, and links into the technical file
- Quality events for CAPA, deviations, complaints, and related follow-up
- Training assignments with clear completion status for your team
- Products and lots tied to the quality records that reference them
- AI proposals and chat over live data, with human confirmation before writes
- Export packs and views geared toward inspection and audit readiness
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