FDA 21 CFR Part 11 applies to companies which need to operate under the purview of FDA regulation, like Pharmaceutical and Biotech Companies, Medical Equipment Manufacturers.
CFR21 Part 11 defines the criteria which need to be fulfilled for electronic records and electronic signatures to be considered trustworthy, reliable and legally equivalent to paper records and signatures.
The standard applies to those companies (FDA-regulated) who want to store their records in electronic format. It specifies the guidelines and rules for storing, copying, setting access and permissions, audit logging and tracking, and managing change and version control of the electronic records and electronic signatures.
An electronic record is defined as as any combination of text, images, data, audio, video or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
CFR21 Part 11 defines the criteria which need to be fulfilled for electronic records and electronic signatures to be considered trustworthy, reliable and legally equivalent to paper records and signatures.
The standard applies to those companies (FDA-regulated) who want to store their records in electronic format. It specifies the guidelines and rules for storing, copying, setting access and permissions, audit logging and tracking, and managing change and version control of the electronic records and electronic signatures.
An electronic record is defined as as any combination of text, images, data, audio, video or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
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