External publications

News & industry watch

Keep track of developments in qualification, validation and pharmaceutical compliance.

Analysis

Our readings of the texts that frame qualification and validation.

CSV & Data Integrity
CSA: what the FDA guidance covers, and what it does not
In February 2026 the FDA issued a final guidance on Computer Software Assurance. It is often cited in pharmaceutical projects — yet its scope is medical devices. The distinction changes what can be drawn from it.
Read the analysis

GMP
GMP News — actualités réglementaires
ECA AcademyOctober 2026 — opens in a new tab
CSV & Data Integrity
Computer Software Assurance for Production and Quality Management System Software
U.S. Food & Drug AdministrationFebruary 2026 — opens in a new tab
GMP
EudraLex Volume 4 — Good Manufacturing Practice guidelines
Commission européenneJanuary 2026 — opens in a new tab
Commissioning
PIC/S Guides and Guidance Documents
PIC/SJanuary 2026 — opens in a new tab
GMP
Bonnes pratiques de fabrication de médicaments à usage humain
ANSMJanuary 2025in French — opens in a new tab
Qualification & Validation
Annex 1 — Manufacture of Sterile Medicinal Products
Commission européenne (EudraLex Vol. 4)August 2022 — opens in a new tab
CSV & Data Integrity
Data Integrity and Compliance With Drug CGMP — Questions and Answers
U.S. Food & Drug AdministrationDecember 2018 — opens in a new tab
Process & cleaning
Process Validation: General Principles and Practices
U.S. Food & Drug AdministrationJanuary 2011 — opens in a new tab

These publications are produced by third parties: regulators, standards bodies and specialist media. C-Validation curates a selection and links to the original documents without reproducing them. All rights remain with their respective publishers.

News & industry watch

CSA: what the FDA guidance covers, and what it does not

GMP News — actualités réglementaires

Computer Software Assurance for Production and Quality Management System Software

EudraLex Volume 4 — Good Manufacturing Practice guidelines

PIC/S Guides and Guidance Documents

Bonnes pratiques de fabrication de médicaments à usage humain

Annex 1 — Manufacture of Sterile Medicinal Products

Data Integrity and Compliance With Drug CGMP — Questions and Answers

Process Validation: General Principles and Practices