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Supported 21 CFR Part 11 Requirements

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21 CFR Part 11

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21 CFR Part 11 (Code of Federal Regulations) is a guideline on electronic records and electronic signatures to be used in the United States of America. The law was passed in August 2007, and aims to defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

The law has gained popularity with various pharmaceutical companies in recent years and is being increasily used worldwide, especially in Europe.

Weist EDV has developer its software solutions to fully comply with the Title 21 CFR Part 11.


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	Integration

For the new development we have combined our point of view of the „Part11“ with the recommendations of our customers with the „GAMP Special Interest Group“. Hence that WeistEDV has created its own catalogue for the strict implementation of the „Part11“ in the WeistEDV Software.


	Information

If you would like to receive more information concerning 21 CFR Part 11, then contact us.

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