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Catalog · Forms
CAPA Request & Record Form
A single-record CAPA form that carries one issue from initiation through effectiveness check — each block capturing exactly the evidence ISO 13485 §8.5.2 expects a record to show.
- File one form per CAPA and have the whole story — problem, cause, action, effectiveness — in one auditable record
- Stop losing effectiveness checks: the form carries the check as a block that must be completed before disposition
- Hand auditors a record whose blocks match the procedure's steps one-for-one
Built like the working documents we write about
Record details block
CAPA number, source, dates and risk priority — the fields your log and trending run on.
Problem statement
A structured statement of what was found, where, and what product or process is affected.
Investigation and root cause
Method used, evidence examined, and a root-cause statement that has to explain the nonconformity, not restate it.
Action plan
Actions tied to the root cause with owners and due dates — document, training and validation impacts prompted.
Effectiveness check
Defined interval, defined evidence, recorded result — the step FDA inspections most often find missing.
Review and disposition
Quality's closure decision with signature and date — the record ends the way §8.5.2 expects.
Why each section exists
Bundle shops sell you a zip and a wish. Every section of this document states the clause it was written to satisfy — the same map is printed inside the document, where your auditor can read it.
Exactly what you get
No surprises at download time — the format, the scope, and the license, stated up front.
- Format
- Microsoft Word (.docx) — no macros, works in Google Docs
- Length
- 6 record blocks · signature and disposition fields included
- Mapped to
- ISO 13485:2016 §8.5.2 and §4.2.5 (records), block by block
- Works with
- RT-SOP-007 CAPA Procedure and RT-LOG-001 CAPA Log — referenced by number in the procedure's §3
- Delivery
- Instant download after checkout, with a re-download link on your receipt
- Updates
- Revised when the source moves; buyers get the new revision by email, free
- License
- One purchase covers your team at one company site
Check our work
A form is where a CAPA system succeeds or quietly fails — the blocks decide what evidence exists at audit time. Read the craft behind it: what a complaint record has to decide before it becomes a CAPA and what a CAPA tracker has to track.
Take the form template to work today.
One purchase, yours immediately at launch — and revised for free when the source moves.