As part of the Food and Drug Administration (FDA) Modernization Act in 2003, 21 CFR Part 11 was created as a criteria under which FDA considers electronic records to be trustworthy, reliable, and equivalent to paper records and handwritten signatures.
It applies to any electronic records that are created, maintained, modified, archived, or transmitted, under any stated record requirements set forth in FDA regulations. It does not apply to paper records sent via Fax or e-mail. Basically, if there is an FDA requirement to keep records, 21 CFR Part 11 applies to the electronic version. Records must be maintained or submitted in accordance with the underlying predicate rules and the FDA can take action for noncompliance. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. Electronic documentation kept for HACCP and other regulations must meet these requirements.
Companies that keep electronic records to satisfy FDA requirements may use them instead of paper records. The agency will consider the electronic signatures to be equivalent to full handwritten signatures, when their electronic records and electronic signatures meet the requirements of this part.
Computer systems (hardware and software), controls, and documentations maintained under this part must be made readily available, if requested, for FDA inspection.
Controls for Closed Systems
When using closed systems to create, modify, maintain, or transmit electronic records, users must utilize methods that ensure integrity, authenticity, and if required, confidentiality. These procedures and controls should include:
Controls for Open Systems
When using open systems to create, modify, maintain, or transmit electronic records , users must utilize methods that ensure integrity, authenticity, and if required, confidentiality. The procedures and controls should include everything mentioned under “Controls for Closed Systems”, as well as additional measures such as document encryption and use of appropriate digital signature standards, to ensure authenticity, integrity, and confidentiality.
Signed electronic records must clearly indicate the following:
The signature manifestation requirements mentioned above must be included on any human readable versions of the electronic forms, such as printouts.
Some general requirements for electronic signatures include:
Controls for Identification Codes/Passwords
When using identification codes in combination with passwords, for the use of electronic signatures, controls must be employed to ensure the security and integrity of the identification codes and passwords. This includes:
All of these FDA regulations can get a bit confusing. That is why a reliable temperature monitoring system is important. E-Control Systems enables you to collect all of your FDA required data by simplifying 21 CFR Part 11 compliance.
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