Corrective and preventive action, tracked from root cause to a proven effective fix.
CAPA Management carries a finding — from a deviation, audit, complaint or nonconformance — through root-cause analysis, an action plan with owners and due dates, implementation, and a scheduled effectiveness check that has to actually happen before the CAPA is allowed to close.
CAPA is the one module regulators name explicitly.
Unlike most quality processes, corrective and preventive action appears by name in both FDA and ICH guidance — which is why it's usually the first system an inspector asks to see.
Written Procedures; Deviations
Requires written procedures for production and process control, and that any deviation be recorded, justified, and — where it affects a critical process — investigated with documented conclusions.
Corrective and Preventive Action
The device QSR requirement that names CAPA directly: procedures for investigating causes, identifying corrective and preventive actions, verifying effectiveness, and documenting results.
Pharmaceutical Quality System
Names the CAPA system as one of four core Pharmaceutical Quality System elements, explicitly requiring documented effectiveness verification before a CAPA is considered complete.
Quality Risk Management
Root-cause analysis and action prioritisation are expected to reflect the actual risk to product quality and patient safety, not a fixed checklist.
The CAPA that doesn't close itself.
Most CAPA backlogs aren't a root-cause problem — they're a follow-through problem. The software is built to make follow-through the default.
One workflow, start to finish
Root cause, action plan, implementation and effectiveness check live in a single record — nothing gets re-entered into a second system.
Effectiveness checks aren't optional
A CAPA can't be marked closed until its scheduled effectiveness check has actually been recorded — no more CAPAs that quietly closed on a deadline.
Every CAPA shows its origin
A CAPA opened from a deviation, audit finding or complaint keeps that link visible for the life of the record, not just at creation.
Nothing goes overdue quietly
Owners and due dates escalate automatically as they approach, so a CAPA doesn't become a surprise at your next management review.
Walk through a real CAPA lifecycle with us.
We'll show root cause, action plan, implementation and effectiveness-check enforcement using a scenario from your own process.