Data Integrity & CSV self-assessment for pharmaceutical plant automation systems

30 questions · about 10 minutes · every question cites the original clause (EU GMP Annex 11, 21 CFR Part 11/211, PIC/S PI 041-1, FDA Data Integrity Q&A 2018).

Pham Duc Phuong Nam — Sales Manager, ESTC (ESEC group). A reference tool; it does not replace your QA department's assessment.

This tool needs JavaScript. It asks 30 clause-cited questions across five control areas — access & accounts, audit trail, time & original data, backup/archival/restore, and change control & validated state — then scores each area against EU GMP Annex 11, 21 CFR Part 11/211, PIC/S PI 041-1 and the FDA Data Integrity Q&A (2018). To have your systems assessed instead, email nam.pham@esec.vn or see the DI & CSV gap assessment offer.