Title 21 CFR Part 11 of the Code of Federal Regulations

This legislation refers to Food and Drug Administration (FDA) guidelines on the use of electronic signatures and data and requires that electronic media maintain the same level of data integrity as storage and data retrieval systems used for paper-based communication.  It specifically targets pharmaceutical and medical device manufacturers, biotech firms, biologics developers, and additional FDA-regulated industries.

The legislation requires that:

• Since an electronic signature is now considered to be the legal equivalent of a handwritten signature, it must be secure, unique and verifiable.  They usually be secure, unique and verifiable. Electronic signatures generally contain a username and password which is tied to the computer of the sender.
  
  
• The FDA requires an audit trail for all electronic records.  This trail must be computer-generated, operator-independent, time-stamped and secure and must contain the complete trail of the document.  This means that changes to the record cannot be made by overwriting prior information.   The original record plus any additions, deletions or modifications must be saved and attributable back to the creator who’s electronic signature is included. 

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