Data Integrity (ALCOA+) & Computer System Validation Kit (Part 11)

Not eligible for NQT documentation review.

Data Integrity (ALCOA+) & Computer System Validation Kit (Part 11)

A computerized system inventory that flags unvalidated systems, disabled audit trails and overdue audit trail reviews, a Part 11 checklist by section number, an audit trail review log, a user access review that flags shared accounts, a risk-based validation plan, a test script and an ALCOA+ policy.

What's inside:

- 00_Start_Here_README.pdf

- 01_Data_Integrity_CSV_Workbook.xlsx

- 02_Validation_Plan.docx

- 03_Test_Script.docx

- 04_Data_Integrity_Policy.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.

Norman Quality Tools is not affiliated with or endorsed by the U.S. FDA, or any other standards body, government agency or company named in this description. Standards are cited by number only; buy the official standard from its publisher.

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

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