Glossary

Computer System Validation Explained for QA Directors

A plain explanation of computer system validation, what it covers, where it breaks down, and what QA and compliance directors are actually accountable for.

GAMP 5 Explained for Compliance Teams

A plain explanation of GAMP 5, its risk based software categories, and what a compliance leader actually needs from it.

21 CFR Part 11 Checklist for Auditors

The core controls a 21 CFR Part 11 review actually checks, in plain language, for QA and compliance teams preparing for an audit.

FDA Computer Software Assurance Guidance Explained

What FDA's Computer Software Assurance guidance actually changes for compliance teams, in plain language, without the marketing spin.

CSV vs CSA, What Actually Changed

A plain comparison of traditional computer system validation and FDA's Computer Software Assurance approach, and what changed between them.

What Does GxP Mean? A Plain Explanation

A plain explanation of what GxP means, which practices it covers, and why the term shows up across so many different regulations.

Data Integrity, ALCOA+ Principles Explained

A plain explanation of the ALCOA+ data integrity principles regulators use to assess whether a GxP record can be trusted.

Risk Based Validation and GAMP 5 Categories

How risk based validation actually works under GAMP 5, and how to size a validation effort without over building or under testing.

Software as a Medical Device and Validation Overlap

How Software as a Medical Device obligations overlap with computer system validation, and where the two frameworks diverge.

GxP Glossary, Terms Compliance Teams Use Daily

A short reference glossary of GxP, CSV, and Part 11 terms that come up constantly in compliance and audit conversations.