Knowledge / Papers
21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions
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.
Relevant Products
Facility Monitoring System (FMS): FacilityPro®
Facility Monitoring System with industrial control assures data integrity, process automation, simplicity of use, and data integration.
PharmaIntegrity Data Integrity
Creates a complete contamination monitoring solution for pharmaceutical manufacturers.
Cleanroom Particle Counter: Lasair® III
Robust and reliable cleanroom particle counter meets the requirements of ISO 14644-1:2015, EU GMP Annex 1 and ISO 21501-4.
Microbial Air Sampler: MiniCapt® Mobile
The innovative microbial air sampler. ISO 14698:2003 compliant
Remote Air Sampler: MiniCapt®
Microbial remote air sampler uses a unique HEPA-filtered exhaust so it doesn’t contaminate your cleanroom.
0.1 Micron Particle Counter: Lasair® III 110
The only true .1 micron particle counter, providing real-time measurement of yield-impacting cleanroom particles with three configurations.
Software SamplerSight
SamplerSight è un programma software facile da usare destinato all’uso di sistemi di misurazione di particelle di liquidi…
Software per Contaparticelle: DataAnalyst
Il software DataAnalyst facilita la comprensione dei dati provenienti dal contatore di particelle per un modo semplice ed economicamente vantaggioso di gestire i dati, compreso il mantenimento di registri elettronici.
Software per Contaparticelle SamplerSight Pharma
Il software per contaparticelle SamplerSight Pharma gestisce i campionatori a siringa e raccoglie dati da un…
