Deviations, CAPAs and change control — one connected quality system.
Built by life science experts to simplify quality management.
“Deviations, CAPAs and change controls used to live in three different tools. Now they live in one — with one audit trail.”
Improved traceability & automation
Replace manual coordination with structured, configurable workflows — with a full audit trail on every action.
Confident compliance
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 — inspection-ready by default.
Data-driven oversight
Monitor activity, backlogs and compliance KPIs in real time so leadership has the visibility it needs.
Faster implementation
Go live in weeks — not quarters — with structured rollout, training and 24/7 support.
From day one — every step controlled.
Deviation & non-conformance
- Capture events with structured intake forms
- Route through investigation, root cause and disposition
- Link to batches, equipment and impacted documents
- Trend by site, product and category
CAPA management
- Track corrective and preventive actions to closure
- Assign owners with due-date enforcement
- Verify effectiveness with structured checks
- Trend recurring issues across sites
Change control
- Assess impact across documents, training, equipment and validation
- Route through cross-functional approvals
- Trigger SOP updates and training reassignment
- Maintain a complete change history
Risk management (ICH Q9)
- Run FMEA and risk assessments inline
- Link risks to CAPAs and change controls
- Track residual risk after mitigation
- Report risk posture to leadership
Everything QMS ships with.
Configurable workflows
Tailor deviation, CAPA and change workflows without code.
Root-cause analysis
Built-in 5-Why, Fishbone and structured RCA templates.
Effectiveness checks
Schedule and verify CAPA effectiveness after closure.
Risk register
Maintain a living risk register linked to events and actions.
Trending & analytics
Live charts by category, site, product, severity.
Integration with DMS, LMS, Audit
Quality events flow naturally into docs, training and audits.
Designed to support the standards you’re audited against.
See QMS on your own data.
Bring a real scenario from your operations — we’ll show you exactly how Quality Management handles it.