Deviations, CAPA & Preventive Actions
Walk through deviations, non-conformance reports, CAPA management, preventive actions, notes, and the records archive — the full corrective-and-preventive workflow inside MoniDoseQMS.
Deviations, non-conformances, CAPA, preventive actions, notes, and archives — the full corrective-and-preventive chain lives here. This guide walks through each module and shows how they connect.
What you'll learn
- 1
Deviation management
Create deviation reports with custom IDs, severity, priority, type (manufacturing, quality control, SOP, equipment, material, human error, training, and more), and link them to any QMS module for traceability.
- 2
Non-conformance reports (NCR)
Log non-conformances with custom IDs, detected dates, module links, and notifications. View, edit, and track each NCR from the action buttons.
- 3
CAPA management
Create CAPAs (corrective, preventive, improvement, or combined), assign priority, track effectiveness, and link to change control records. Apply electronic signatures for FDA, EU MDR, and UK compliance. Follows ISO 13485:2016 clauses 8.5.2 and 8.5.3.
- 4
Preventive actions
Prevent potential problems before they occur. Create with custom IDs, follow the built-in guide, attach evidence, and save.
- 5
Notes
Contextual notes attached to any record or module — keep your team informed about what's happening across the QMS.
- 6
Archive management
Review archived documents with retention periods (up to 20+ years), original source traceability, approval details, and the ability to review what you've archived at any time.
How they connect
A deviation triggers a CAPA, the CAPA links to a change control, and the closed record gets archived with a retention period. Notes tie them all together. Everything is traceable end-to-end.