The FDA 21 CFR Part 11 was established by the US Food and Drug Administration (FDA) to ensure the authenticity, integrity, and confidentiality of electronic records and electronic signatures. This part of the regulation governs how electronic records and signatures...
Companies subject to 21 CFR Part 11 must adhere to strict requirements for electronic records, electronic signatures, and computer systems to comply with the FDA regulations. To help companies stay on top of regulatory compliance, we have examined official FDA data,...
Life Science companies can use open or closed computer systems for managing electronic records and signatures according to 21 CFR Part 11. But what is the difference between the two? This article explains the difference between open and closed systems as per Title 21...
The 21 CFR Part 11 is part of a regulation enforced by the Food and Drug Administration (FDA) that outlines the requirements for electronic records and electronic signatures. These requirements are relevant for Life Science companies that operate in the United States...
The 21 CFR Part 11 is a part of the regulation by the US FDA that establishes the criteria for electronic records and digital signatures. According to this regulation, all electronically stored records must have an audit trail ensuring traceability. Audit Trails are a...
21 CFR Part 11 compliant electronic signatures refer to digital signatures that meet the Food and Drug Administration (FDA) 21 CFR Part 11 regulation requirements. Their goal is simple: to ensure that the signatures and signed documents are trustworthy, reliable, and...
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![21 CFR Part 11 Password Requirements [Explained]](svg/21-cfr-part-11-password-requirements.svg)
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![21 CFR Part 11 Audit Trail Requirements [Explained]](svg/fda-21-cfr-part-11-audit-trail-illustration.svg)
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