Your Complete Source for 21 CFR 11 and Data Integrity Regulations
21 CFR 11 and Data Integrity may be a challenge when bringing manufacturing processes and control to a new level. Here we provide several sources of information to help everyone who needs to comply with full data integrity related standards.
Get a better understanding of 21 CFR 11 and Data Integrity regulations by watching the recorded webinar at the right and learn about becoming compliant with GMP and FDA requirements by reading the paper below.
Have a question? Submit your question for one of our experts to answer (see the bottom right).
Do you need a product to help you comply with these regulations and reach compliance? If yes, see our list of relevant products at the bottom.
Knowledge / Papers
21 CFR Part 11 and Data integrity refers to data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product’s quality and public safety. Learn how to manage data for data integrity.
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.
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.