One-click open from any source
Deviations, audit findings, incidents, and risk treatments spawn CAPAs typed by their source. The trail starts where the problem did — never retyped.
CAPA · Corrective & Preventive Action
CAPAs that prove the fix actually worked.
Root-cause analysis with bound evidence, owned action plans, separation-of-duties closure, and a scheduled effectiveness check — exported as one binder your auditor accepts unedited.
Built for ISO 9001 §10.2, 21 CFR Part 11-shaped workflows, and ISO 13485
Everything a CAPA needs to close — and stay closed.
RCA evidence editor
5-Whys, fishbone, or free-form root-cause analysis with evidence files content-hashed to the record. The investigation is the artifact, not an attachment.
Action-plan builder
Corrective and preventive actions with owners, due dates, and verification criteria. Each action is its own audit-trailed task.
Separation of duties
The assessor cannot approve their own closure. Blocked in the UI, enforced server-side — the auditor sees the control, not just the policy.
Effectiveness check
A scheduled check confirms the fix held before the CAPA truly closes. "Closed" stops being a hope and becomes a gate.
CAPA binder export
Intake, RCA, actions, signatures, and the hash chain in one PDF that verifies on your auditor's machine.
From "something went wrong" to "verified closed."
- 1
Open
A deviation, finding, or incident opens the CAPA with its source linked by ID.
- 2
Investigate
Run root-cause analysis with bound evidence and build the action plan.
- 3
Close
A re-authenticated e-signature closes it — and the assessor cannot be the approver.
- 4
Verify
The scheduled effectiveness check confirms the fix held. Export the binder.
What this satisfies
- ISO 9001 §10.2
- 21 CFR Part 11-shaped
- EU GMP
- ISO 13485
"Shape" means we mirror the regulation's evidence, signature, and audit-trail requirements in our data model. See Trust & Security for the current certification state.
“Our CAPAs used to live in three places and close on a vibe. Now the effectiveness check is a gate, not a hope — and the binder exports in one click.”
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