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. 

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Knowledge / Papers

Data Integrity: Understanding and Becoming Compliant with GMP and FDA Requirements

Data integrity means 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. 

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Relevant Products

 

FacilityPro® Environmental Monitoring

FacilityPro® Environmental Monitoring

Industrial control systems assure data integrity, process automation, simpicity of use, and data integration. 

Lasair® III Airborne Portable Particle Counter

Lasair® III Airborne Portable Particle Counter

Sets the standard for portable aerosol particle counters and meets the requirements of ISO 14644-1:2015 and  ISO 21501-4

MiniCapt® Mobile Microbial Air Sampler

MiniCapt® Mobile Microbial Air Sampler

The innovative solution to microbial air sampling. ISO 14698:2003 compliant

MiniCapt® Remote Microbial Air Sampler

MiniCapt® Remote Microbial Air Sampler

Uses a unique HEPA-filtered exhaust so it doesn’t contaminate the cleanroom.

Lasair® III 110 Airborne Particle Counter

Lasair® III 110 Airborne Particle Counter

A true 0.10 μm particle counter, providing real-time measurement of yield-impacting particles with three configurations.

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Recorded Webinar

Data Integrity / 21 CFR 11

Understanding 21 CFR 11 and Data Integrity Regulations

PRESENTER Daniele Pandolfi Global Product Specialist Aerosol, Life Science Division

Watch this on-demand webinar to understand 21 CFR 11 and Data Integrity Regulations and learn about full data integrity related standards compliance.

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Ask a Question

Data Integrity / 21 CFR 11

Do you have a 21 CFR 11 or Data Integrity question? Submit your specific question below and one of our experts will respond shortly.