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Catalog · Logs & registers

CAPA Log

A one-row-per-CAPA register whose columns are chosen for what you must trend — aging, source, risk priority and effectiveness — so management review gets data, not anecdotes.

XLSX register13 columnsCompanion to RT-SOP-007 CAPA procedure
  • See CAPA aging and overdue effectiveness checks at a glance — the two numbers inspections ask for first
  • Trend by source and risk priority into management review without rebuilding the data every quarter
  • Keep closed CAPAs' history — the log's rules say rows are never deleted
What's inside

Built like the working documents we write about

  • Identity and priority columns

    CAPA number, date opened, source and risk priority — the fields that drive proportionate handling.

  • Ownership and phase

    Owner and phase columns make stalled CAPAs visible before they become audit findings.

  • The two clocks

    Action due and effectiveness-check due dates — the log tracks both, because closing actions is not proving effectiveness.

  • Effectiveness result

    Recorded per CAPA, so the register itself shows whether your system prevents recurrence.

  • Closure and notes

    Date closed plus a notes column — history stays in the row, never deleted.

  • Usage rules in the header

    One row per CAPA; never delete rows; adopt under your own document control — printed where users see them.

The source map

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.

Document sectionSatisfies
Source + Risk Priority columnsISO 13485 §8.5.2(a) · review of nonconformities by source, action proportionate to risk
Action Due / Phase columnsISO 13485 §8.5.2(d) · planned actions implemented on a tracked clock
Effectiveness columnsISO 13485 §8.5.2(f) · effectiveness reviewed with a due date and a recorded result
Aging across all rowsISO 13485 §8.4 · analysis of data — aging, source and recurrence trends
Register as a wholeISO 13485 §5.6.2 · the CAPA-health input management review expects
Whole documentFDA QMSR (21 CFR 820, eff. 2026-02-02) · incorporates ISO 13485:2016 by reference
The details

Exactly what you get

No surprises at download time — the format, the scope, and the license, stated up front.

Format
Microsoft Excel (.xlsx) — no macros, works in Google Sheets
Length
1 register sheet · 13 columns · usage rules printed in the header
Mapped to
ISO 13485:2016 §8.5.2, §8.4 and §5.6.2, column by column
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

Every column exists because something downstream consumes it — a trend, a clock, or a management-review slide. Read the craft behind it: what a CAPA tracker has to track and how a template goes stale.

Take the log template to work today.

One purchase, yours immediately at launch — and revised for free when the source moves.