QMS software for life sciences

Bring all your quality processes, documents, training, CAPAs, and audit trails together in one compliant eQMS—aligned with 21 CFR Part 11, Annex 11, ICH guidelines and GxP requirements.

Turn regulatory training into a clear compliance trail. Manage training with a structured, role-based approach that ensures the right people get the right content at the right time.

Be ready before the inspector arrives. Keep quality records, documents, training evidence, CAPAs, deviations, and audit trails traceable in one compliant quality management system.

Streamline your CAPA workflow. Create clear CAPA plans with defined roles and key details, launch CAPAs directly from events, and manage related changes without losing traceability.

Manage design controls, quality documents, changes, and traceability in one validated QMS software— built to ensure regulatory readiness under ISO 13485, FDA QMSR, and EU MDR.

Connect design inputs, outputs, reviews, risks, verification, validation, and change control in one validated design and development solution for the medical device industry.

Create up-to-date, audit-ready reports straight from your project workspace—ready to share with internal teams, external partners, auditors, or regulatory bodies.