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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.
SamplerSight Software
A user-friendly software program for operating batch-based liquid particle measurement systems. Provides a comprehensive view of the batch information.
Particle Counter Software: DataAnalyst
DataAnalyst Software helps you understand the data coming from your particle counter for an easy and low-cost way to manage data, including maintaining electronic records.
SamplerSight Pharma Particle Counter Software
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.
Facility Net Monitoring Software
Real-time and historical data display for all Particle Measuring Systems particle counters, molecular contamination monitors and various third-party products.
