Learn about 21CFR Part 11 requirements and find compliant solutions from Particle Measuring Systems.
Knowledge / Papers
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.
Facility Monitoring System with industrial control assures data integrity, process automation, simplicity of use, and data integration.
Designed for intuitive and reliable portable and remote airborne particle counting. Meets global regulatory requirements including Annex 1.
This active air cleanroom microbial air sampler is EU GMP Annex 1 and ISO 14698:2003 compliant.
Annex 1 compliant, remote microbial air sampler uses a unique HEPA-filtered exhaust to reduce contaminate introduction to your cleanroom.
Creates a complete contamination monitoring solution for pharmaceutical manufacturers.
The only true .1 micron particle counter, providing real-time measurement of yield-impacting cleanroom particles with three configurations.
A user-friendly software program for operating batch-based liquid particle measurement systems. Provides a comprehensive view of the batch information.
SamplerSight Particle Counter Software controls syringe operated samplers and collects data from a LiQuilaz particle sensor. Easy USP 788 calibration. 21 CFR Part 11 compliant.
Real-time and historical data display for all Particle Measuring Systems particle counters, molecular contamination monitors and various third-party products.