Category for News


Revised GAMP®5 guidelines published

August 11, 2022 9:36 am Published by

GAMP®5, a Risk-Based Approach to Compliant GxP Computerized Systems Guidelines, is a globally accepted standard for the validation of computerised systems that has been recently revised. In the end of July 2002, a new 2nd edition has been published.


FDA Approved?

July 22, 2022 10:47 am Published by

The U.S. Food & Drug Administration (FDA) posted an article on the ways the FDA is regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food, and cosmetics (Is it Really “FDA Approved”).