Data Integrity Risk Assessment in Computerized Systems According to GAMP 5 v2
The digital transformation of the pharmaceutical industry has significantly increased the dependence on computerized systems for the generation, processing,
Normative
How the new GMP Annex 15 is expected to affect API, veterinary and cosmetic plants
The revision of Annex 15 of the European GMP (Qualification and Validation) represents a significant change in the evolution of
Data Integrity in hybrid systems: good practices for paper and electronic systems
Digitalization is advancing steadily in the pharmaceutical industry, but operational reality shows that many organizations are still working
Integrating QA and regulatory compliance from the conceptual phase
In the pharmaceutical sector, quality is not an attribute added at the end of the project; It is a structural condition that
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
Impact of the Annex 15 revision on manufacturers
In the previous article we analyzed what changes Annex 15 brings and what key message the inspectors are sending, as well
GMP Annex 15 is currently under review
Annex 15 – Qualification and Validation is one of the classic pillars of European GMP and, precisely because
The new EMA GMP inspection plan until 2028: when supervision becomes a strategy
In January 2026, the new GMP/GDP Inspectors Working Group (GMDP IWG) work plan came into effect.
Risk Management in Aseptic Manufacturing: Practical Application of ICH Q9
Aseptic manufacturing represents one of the most critical environments within the pharmaceutical industry. The absence of a
Data Integrity according to FDA, EMA and MHRA
Data Integrity is a central pillar in the pharmaceutical industry and in any regulated environment.