A CAPA is only worth the discipline behind it. Without an enforced lifecycle, each step takes the finding further from a resolved cause — and the last one is only discovered at the next inspection.
An audit observation is recorded in a spreadsheet, an action is agreed in a meeting, and nothing enforces the gap between the two.
“Human error” is recorded as a root cause. No method is named, no systemic condition is identified, and the action plan that follows cannot prevent recurrence.
Actions are completed and the record is closed. Whether the root cause was eliminated is discovered at the next inspection, from a repeat finding.
An inspector asks for every CAPA raised against a study, by source and risk level. The answer is assembled from email, minutes and a spreadsheet.
Each control writes to, and reads from, the same CAPA record — from the finding first logged to the closure statement an inspector reads.
Each CAPA is a record with a defined structure — typed fields, linked context, and a stage it has verifiably reached.
Module, study, site-file category and document — four references tying the finding to the research that produced it.
Four levels, each carrying a configured SLA, so the due date is derived from the classification rather than entered manually.
Eight stages, each with a defined entry condition. A record advances only once the preceding stage is complete.
Workflow actions are presented only to the individual named on the stage the record has reached.
Deletion is reversible, closure is permanent, and every workflow action is retained with its user and timestamp.
Action items, approvals and verifications are routed to the named individual’s task list without manual distribution.
Where records are accumulating, what is overdue, and whether closure rates are keeping pace with new findings.
A report library drawn from the same record, so an inspection request is answered by filter rather than by reconstruction.
Each stage names the role that acts, and a stage cannot be skipped. Select any stage to follow CAPA-0184 through it.
Each role holds the CAPA for defined stages, then hands it on. A workflow button appears only for the person named on the stage the record has reached.
Six views over the same portfolio. Each answers a different question a governance meeting actually asks.
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No. Closure is only reachable after an effectiveness verification outcome of Effective has been recorded at stage 7. A Not Effective outcome returns the CAPA to Action Planning automatically, and the cycle of revise, re-approve, re-implement and re-verify repeats until the root cause is eliminated. This is the module’s central control — a CAPA closed on an ineffective action is what produces repeat findings.
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AQ CAPA · Corrective and preventive action