Noticias – Software

29 agosto, 2022

GAMP 5 segunda edición. Principales novedades

En julio de 2022, la ISPE publicó la segunda edición de la guía GAMP 5. Desde la publicación de la primera edición en 2008, se han […]
4 febrero, 2021

Decommissioning of computerized systems in Pharma industry

Often, one of the missing points in the pharmaceutical industry is the retirement of computerized systems, as well as the retention of data generated in them. […]
6 abril, 2020

Data Integrity and Compliance With Drug cGMP: Q&A Guidance for Industry

Just last week, the US FDA published the final version of its Data Integrity and Compliance with cGMP Guidance, which had been issued as a draft in […]