
GAMP® 5: The Quality Strategy for Computerized Systems
In the era of Industry 4.0, digital transformation in the regulated sector is no longer an advantage

In the era of Industry 4.0, digital transformation in the regulated sector is no longer an advantage

In the previous article we analyzed what changes Annex 15 brings and what key message the inspectors are sending, as well

Annex 15 – Qualification and Validation is one of the classic pillars of European GMP and, precisely because

In January 2026, the new GMP/GDP Inspectors Working Group (GMDP IWG) work plan came into effect.

Decommissioning GMP (Good Manufacturing Practices) equipment is the formal and documented process for removing equipment.

Water is one of the most relevant critical services in the pharmaceutical industry. Its transversal use (from the formulation

In the pharmaceutical industry, maintenance is not only a technical function aimed at the availability of assets. It's a

Over the last decade, artificial intelligence in the process industry has gone through a phase of experimental enthusiasm characterized

From healthcare design to documentary evidence In the two previous articles in this series of three technical publications we have