What is 21 CFR Part 11?

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The 21 CFR Part 11 (often just called Part 11) was created by Food and Drugs Administration in the US (www.fda.gov/ora) and is a federal law for requirements for computerized systems, their electronic records, and their electronic signatures. It is mandatory for all computer systems in use in the pharmaceutical industry. 21 CFR Part 11 has three types of requirements:
• Technical features that need to be built into the system;
• Procedural requirements that the user of the system needs to make;
• Requirements for validation of all technical features.
The FDA withdrew all their draft guidelines for Part 11 and added one new "Guidance for Industry - Scope and application" in August 2003. This guidance requires the user to use a risk-based approach for which systems are to be included.

A supplier can never sell a “Part 11 compliant” system, as the procedures are needed in the user organization and the validation also has to be done by the user organization. However, he can sell a technically compliant system, and this should also be a requirement in the URS.

You can read about Part 11 case studies here.