Knowledge / Papers
This paper, Understanding and Becoming Compliant with GMP and FDA Requirements, discusses data (such as from personnel or environmental monitoring) requirements and management.After reading this paper you will better understand 21CFR11 and how to be compliant.
This FAQ paper is a follow up to the webinar, “Understanding 21 CFR Part 11 and Data Integrity Regulations”. Many thoughtful questions were asked about the specific guidelines of 21 CFR Part 11 relating to data integrity, and how they impact operations. Read questions and answers submitted during and after the webinar and also submit questions of your own.
Industrial control systems assure data integrity, process automation, simpicity of use, and data integration.
Creates a complete contamination monitoring solution for pharmaceutical manufacturers.
The innovative microbial air sampler. ISO 14698:2003 compliant
Microbial remote air sampler uses a unique HEPA-filtered exhaust so it doesn’t contaminate your cleanroom.
A true 0.10 micron particle counter, providing real-time measurement of yield-impacting cleanroom particles with three configurations.
SamplerSight è un programma software facile da usare destinato all’uso di sistemi di misurazione di particelle di liquidi…
Il software DataAnalyst facilita la comprensione dei dati provenienti dal contatore di particelle per un modo semplice ed economicamente vantaggioso di gestire…
Il software SamplerSight Pharma gestisce i campionatori a siringa e raccoglie dati da un…