Quality management
Hybrid QMS
Manage deviations, corrective actions, changes and risk assessments in one quality management system. See who needs to act, what is overdue and which records are waiting for a decision.
For quality teams, department leads and the people assigned to investigate, act or review.
What you can manage
Deviations
Record what happened, investigate the cause and track the actions needed to address it.
Corrective and preventive actions
Assign actions to named people, set due dates and review completion against the source quality record.
Change control
Keep proposed changes, their assessments and implementation actions together, from initiation through review.
Risk assessments
Maintain a register of assessments and the actions associated with the risks you identify.
Effectiveness checks
Plan follow-up checks to establish whether the action taken resolved the issue. Record the result before closure.
Oversight and reporting
Review overdue work, critical items, pending decisions and upcoming dates. Use registers and KPI reports to examine the detail.
Explore the dashboard
Select “Overdue work” to see the outstanding actions, then open a record for its owner, due date and next step.
Consinova Hybrid QMSExample dataYour dashboard
Outstanding work, upcoming dates and decisions.
Overdue work
| Record / work | Owner | Date | Status | Open record |
|---|---|---|---|---|
| Quality | 27 Oct 2026 | Overdue | ||
| Warehouse | 28 Oct 2026 | Overdue | ||
| Engineering | 02 Nov 2026 | Awaiting review | ||
| Quality | 06 Nov 2026 | Planned | ||
| Production | 04 Nov 2026 | Awaiting decision |
Example records in a website demonstration based on the system dashboard.
Configuration, tailoring and bundles
Discuss the records, roles, workflows and reports your organisation needs. This system can be included in a quote with any of the other Consinova systems.
Discuss this system or a bundleValidation
Annex 11 and Annex 15
Consinova systems can be validated in compliance with EU GMP Annex 11 and Annex 15 for their intended use.
Validation is specific to the configured system, the way your organisation uses it and the procedures that support it. The scope, risk assessment, testing, evidence and responsibilities are agreed for your implementation.
Include validation in your enquiry EU GMP guidance: Annex 11 — Computerised Systems; Annex 15 — Qualification and Validation ↗
