CH 13 · notes
How it works
Fill a GMP-style CAPA draft in the browser: describe the event, choose 5-Why or a fishbone (Man, Machine, Method, Material, Measurement, Environment), then record corrective actions, preventive actions, an owner, a due date, and an effectiveness check. The preview mirrors the export structure. Libraries for DOCX and XLSX load only when you click Export. Nothing is uploaded.
Worked example
Invented title CAPA-DEMO-001: a skipped balance daily check leads to an overweight buffer lot. 5-Why ends at a checklist change that omitted the weighing-area gate. Corrective action quarantines and remakes the lot; preventive action updates the open-shift checklist and trains staff. Owner QA Specialist, due 2026-11-30. Load example fills the same invented fields.
Related tools
Nitrosamine planning limits are on the Nitrosamine Limit calculator. Residual solvent limits use the Residual Solvent Limit calculator. Assay scatter uses the RSD calculator.
FAQ
What is a CAPA template?
A Corrective and Preventive Action draft records a deviation, the root-cause method, corrective actions that fix the immediate issue, preventive actions that reduce recurrence, an owner, a due date, and how effectiveness will be checked. This page formats that structure in the browser.
How do 5-Why and fishbone differ here?
5-Why walks five chained why answers into a root-cause summary. Fishbone collects notes under Man, Machine, Method, Material, Measurement, and Environment, then the same summary. Switch methods without losing the other method's typed notes; the URL keeps only the active method's keys.
Are exports uploaded or controlled records?
No. DOCX, CSV, and XLSX are built in the browser after you click Export. Libraries load on demand. The draft is invented-example wording for planning, not a controlled quality-system record and not a claim of compliance with a specific regulation.
Does the page upload my CAPA text?
No. Formatting and export stay on this device. The panel notice is the data statement for this page.