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

Understanding and Becoming Compliant with GMP and FDA Requirements

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. 

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Understanding 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. 

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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 micron 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. 

Frequently Asked Questions

Does Part 11 apply to records created manually and then scanned? Are they considered electronic?

Yes, if you’re using those scanned documents as your data, it is considered an electronic record and 21 CFR
Part 11 applies.
Managing scanned documents may be tricky when trying to have a consistent traceability of version
history. In this case, electronic signature software such as Adobe Sign may help to ensure validation of
document signatures and version traceability.

Is data Integrity relevant for serialization (enforced in Europe in February 2019)?

Yes, drug serialization will employ computerized systems which will need to comply with recent data
integrity standards.
Drug serialization will be enforced to guarantee traceability of product, meaning all associated operations,
generated data, actions and information of the drug’s production process can be tracked using a single serial
number. This can only be done with secure and compliant computerized systems in place.

Are these SOPs also applicable for GAMP category 3 software (e.g., PLC, laboratory software for HPLC, etc.)?

These SOPs apply to computerized systems used in the company. GAMP category 3 requires less
intervention, maintenance and validation efforts than a category 4 or 5 software. The SOP should not be
related to a signal device/system, but generally enforced as part of the company’s quality standards.