Title 21 CFR Part 11 – Regulation on electronic records and electronic signatures

If you are doing business with or through the Food and Drugs Administration, meaning if you are, if you contract or interact with drug and medical equipment manufacturers, healthcare, laboratories or medical services related companies, chances are you may need to be compliant with the FDA Regulation Title CFR 21 Part 11.

Title CFR 21 Part 11 is a guidance that represents FDA current thinking on electronic records and signatures, therefore how the FDA-governed industries must handle this subject. It defines what they need to be considered authentic, reliable and equivalent to paper records.
art 11 specifies how these FDA-governed industries must handle electronic records and signatures and define the criteria under which they are authentic, reliable, and equivalent to paper records.

If you need to be compliant with Title CFR 21 Part 11, you will need to implement controls such as internal audits, controls, audit trails, system validations, electronic signatures, and documentation for software involved in processing electronic data that FDA rules require to be maintained.

Summing up, Title CFR 21 Part 11 exists to assure that electronic records are as safe as paper records, and by electronic records it means “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.”

You can read the entire document here.

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