Electronic records--theircreation, modification, maintenance, retrieval, and archiving--can create ongoing challenges for all organizations. For industries regulated by the U.S. Food and Drug Administration (FDA), such as pharmaceutical companies, medical device manufacturers, food processing plants, and biotech companies, the FDA’s Code of Federal Regulations Title 21 Part 11 applies to the specifications, use, and control of electronic records and electronic signatures.

The requirements of FDA 21 CFR Part 11 for electronic records are based on good practices, organization, and, most of all, common sense to ensure the efficient and secure handling of these records. In general, these requirements state that:

• All information is complete, and all records can be tracked to their originator and corresponding records.

• Appropriate securities are in place to ensure that tampering that would alter the record from its original intent does not take place.

• Only the appropriate parties can access the records, and only those so identified can create, modify, or review those records.

• Authorizing parties are identified, and dates of those authorizations are recorded.

• Information can be viewed in a timely fashion either electronically or in a paper format.

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