21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States.

Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

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Documentation for Software and Systems

Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are:

• Required to be maintained by the FDA predicate rules;
• Used to demonstrate compliance to a predicate rule.

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FDA Requirement

The rule also applies to submissions made to the FDA in electronic format (e.g., a New Drug Application) but not to paper submissions by electronic methods (i.e., faxes). It specifically does not require the 21CFR1 requirement for record retention for tracebacks by food manufacturers. Most food manufacturers are not otherwise explicitly required to keep detailed records, but electronic documentation kept for HACCP and similar requirements must meet these requirements.

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State of Compliance

Our 21 CFR Part 11 template will assist you bringing any application or system into its required state of compliance including some of the questions below

• Does the computer system create, modify, maintain, store or archive, retrieve or transmit data, records or documents required by the quality system/predicated rule?
• Is the system capable of producing accurate and complete copies of records in electronic form for inspection, review and copying by the FDA?
• Is there a secure, computer generated, time stamped audit trail that records the date and time of operator entries and actions that create, modify, or delete electronic records?
• If the sequence of system steps or events is important, is this enforced by the system (e.g. as would be the case in a process control system)?
• Is there a formal change control procedure for system documentation that maintains a time sequenced audit trail of changes?
• Is the signature made up of at least two components, such as an identification code and password, or an id card and password?
• Is there a procedure for electronically disabling an identification code or password if it is potentially compromised or lost?

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