Technical articles
30/04/2026
Major Evolutions of EU GMP Chapters 1 and 4: Towards a Reinforced Governance of Quality, Data, and Knowledge
European regulatory authorities have initiated a revision of Chapter 1 (Pharmaceutical Quality System) and Chapter 4 (Documentatio
8/01/2026
Behind every Smart AI is smarter Data Management
Artificial Intelligence (AI) is reshaping industries, influencing decisions from medicine to transportation, finance to entertainm
23/10/2025
IT Infrastructure Qualification: Better Risk Management Due to Regulatory Requirements
The qualification process—covering IQ, OQ, and PQ—takes a structured and thorough approach to validating technical components
27/02/2025
EN ISO 13485: 2016 / A11: 2021: The Strategic Lever to Transform Compliance into Competitiveness
ISO 13485 positions itself as an essential tool to protect patients and users while strengthening their confidence in medical devi
12/09/2024
Quality Management System Regulation (QMSR), the FDA’s new regulation applicable to medical devices: We explain it all!
The QMSR, published by the FDA, imposes new requirements on medical device manufacturers. Discover the key changes to comply with
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30/05/2024
Shared audits: a simple, cost-effective solution for suppliers, subcontractors and service providers
Suppliers, subcontractors and service providers are increasingly called upon by their customers to carry out assessment audits. Th
6/11/2023
ICH Q12 application for the implementation of a change: example of a site transfer
The ICH Q12 guideline entitled « Technical and regulatory considerations for pharmaceutical product life cycle management” is
4/10/2022
EU GMP Annex 1 update: what has changed, and what are the impacts?
EU GMP Annex 1 on good manufacturing practice defines rules for the manufacture of sterile medicinal products. Based on a 2008 ver
