Here is what you need to know to understand and comply with 21CFR11:
Knowledge / Papers
Data Integrity: Understanding and Becoming Compliant with GMP and FDA Requirements for 21 CFR Part 11
This paper, “Understanding and Becoming Compliant with GMP and FDA Requirements”, discusses data (such as environmental monitoring data or data from personnel) requirements and management. After reading this paper you will better understand 21 CFR Part 11 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.
A user-friendly software program for operating batch-based liquid particle measurement systems. Provides a comprehensive view of the batch information.
Helps you understand the data coming from your particle counter for an easy and low-cost way to manage data, including maintaining electronic records.
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.