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...
The 21 CFR Part 11 is a Food and Drug Administration (FDA) regulation specifying the requirements for electronic records and signatures. The purpose of 21 CFR Part 11 is to ensure the integrity, reliability, and authenticity of electronic records and signatures. This...
![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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