System-level validation, when deployed early and continuously, functions not as a downstream quality checkpoint, but as an organizational mechanism for compressing schedule risk before capital and ...

The FDA has accomplished one of the most important regulatory overhauls in decades by replacing the traditional Quality System Regulation (QSR) with the Quality Management System Regulation (QMSR).

An often overlooked but critically important step along the path from bench to bedside, Process Performance Qualification (PPQ) often results in delays and potential non-compliance issues without ...

Identity verification leader’s validation effort emphasizes commitment to European regulatory standards and digital trust AU10TIX, a global provider of identity verification and authentication ...

1 MedPharm Manufacturing Services LLC, Durham, USA. 2 Veranova, Devens, USA. 3 Lupin Somerset, Somerset, USA. 4 APPCO Pharma LLC, New Jersey, USA. 5 Dr. Hotha’s ...

Researchers at the University of Waterloo have discovered a way to turn plastic waste into acetic acid, the main ingredient of vinegar, using sunlight. The breakthrough offers a promising new approach ...

Dr. Siva Samy is the founder and CEO of ValGenesis, an inventor with 8 patents in digital and AI-based validation, and a Ph.D in Pharma. For decades, validation in life sciences has been treated as a ...

Cell therapy offers a revolutionary approach to treating and curing diseases. But that potential comes with a high level of complexity—one that developers grapple with throughout the manufacturing ...

Join us in person or virtually at the upcoming KENX Validation University and Pharmaceutical Engineering Summit 2026, taking place March 19–20, 2026 in Philadelphia, PA. Stay ahead of evolving FDA and ...

MONROVIA –The Liberia Agriculture Commodity Regulatory Authority (LACRA) has formally announced the introduction of a national policy framework for the palm oil sector under its regulatory regime, ...