CAPA that can't close
without proof it worked.
A spreadsheet will happily let you mark a CAPA "Closed" with an empty effectiveness-check column. ValiCore won't. Root cause, corrective action, and a documented effectiveness check are required stages — not optional fields.
What is CAPA in pharma, and why does it matter more than most modules?
CAPA — Corrective and Preventive Action — is the process of investigating a quality problem, fixing its root cause, preventing recurrence, and proving the fix worked. It's the single most-audited eQMS module because CAPA is where a real quality system either closes the loop or quietly leaves it open. A documented, real-world pattern: a company tracking 200+ open CAPAs across paper forms and Excel couldn't produce a clear status report when an inspector asked — resulting in an avoidable Form 483. CAPA software exists specifically to make that scramble structurally impossible.
Built for
What goes wrong without it
CAPAs closed without an effectiveness check
Corrective action implemented is not the same as corrective action verified. Many CAPA processes stop at "action taken" without a documented check that the root cause actually stopped recurring.
No visibility into what's actually open
Fragmented CAPA records across spreadsheets and email threads can't produce an on-demand, accurate count of open items — the exact question an auditor asks first.
Root cause analysis skipped or superficial
"Operator error" as a root cause, with no Five Whys or fishbone analysis behind it, is a documented pattern that inspectors specifically flag as inadequate investigation.
What ValiCore actually does here
Structured root cause capture
Five Whys-style root cause documentation required before a CAPA can move to the action stage — not a free-text field that gets skipped.
Corrective + preventive action tracking
Separate, trackable action items for the immediate fix and the systemic prevention — with owners and due dates.
Mandatory effectiveness check before closure
A CAPA cannot be marked closed without a documented effectiveness check — the exact gate most spreadsheet-based processes skip.
ICH Q10Linked to the source event
CAPAs originate from and stay linked to incidents, OOS investigations, or audit findings — so the full chain of evidence is one click away, not three systems.
21 CFR Part 11 e-signature on closure
Closing a CAPA requires an e-signature with a captured meaning — an auditable attestation, not a status dropdown.
21 CFR Part 11Real-time open-CAPA dashboard
Every open CAPA, its age, and its owner, visible instantly — the report a spreadsheet-based process can never produce fast enough.
Regulations this addresses
Related modules
Frequently asked questions
Corrective action addresses the specific problem that already occurred — fixing what went wrong this time. Preventive action addresses the systemic cause so the same category of problem doesn't recur elsewhere. A CAPA that only implements a corrective action without a preventive component hasn't closed the loop — which is exactly why both need separate, trackable fields rather than one combined "action taken" box.
There's no single fixed regulatory number, but the expectation is that CAPA timelines are risk-based and documented in your own SOP, with aging CAPAs escalated rather than left silently open. What auditors actually check is whether your system can show CAPA age and status on demand — a spreadsheet-based process often can't answer this quickly, which is itself flagged as a finding.
It shouldn't be — this is the single most common gap in manual CAPA processes. An effectiveness check confirms the root cause actually stopped recurring, not just that an action was performed. ValiCore makes this check a required gate before closure is possible, rather than an optional field a busy QA team can skip under deadline pressure.
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