About

GxP Guys is a plain-English guide to Computer System Validation, GxP and data integrity, written for people learning the field and preparing for roles in it.

Everything here is general educational content drawn from public regulations and guidance (such as GAMP 5, EU Annex 11, 21 CFR Part 11 and ICH), with worked examples built from invented systems. It is not advice for any specific company or system.

Contact

Questions, corrections or suggestions: hello@gxpguys.com.