Pharma Deviation, CAPA & Change Control Kit

Not eligible for NQT documentation review.

Pharma Deviation, CAPA & Change Control Kit

A deviation log that flags investigations past 30 days and majors without a CAPA, a CAPA tracker with effectiveness checks, a change control log that flags changes implemented before QA approval, a deviation investigation report and a change control form.

What's inside:

- 00_Start_Here_README.pdf

- 01_Pharma_Deviation_CAPA_Change_Workbook.xlsx

- 02_Deviation_Investigation_Form.docx

- 03_Change_Control_Form.docx

Written by Matt Norman: 15 years as a U.S. Navy aviation structural mechanic, then 3 years at SpaceX as a Falcon 9 quality inspector and QA supervisor, with hands-on experience working under ITAR and DoD compliance requirements. Norman Quality Tools is Veteran-Owned & Operated.

License: one company, all sites. Word/Excel 2016+, Microsoft 365, LibreOffice. No macros.

Templates, not regulatory advice.

Not affiliated with or endorsed by SpaceX or any other current or former employer of the author.

Norman Quality Tools is not affiliated with or endorsed by any standards body, certification body, government agency or company named in this description.

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