According to the FDA 21 CFR Part 11 documentation, an electronic signature is defined as “a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.”
Electronic signatures are intended to serve the same legal purpose as handwritten signatures and are commonly used to approve or verify records in electronic systems. In a CMMS, an electronic signature may be applied in various ways, such as:
- Typing a name in a field
- Clicking a checkbox that indicates approval
- Drawing a signature using a touchscreen or signature box
- Entering a username/password combination at the time of signing
Compared to digital signatures, which use encryption and certificate-based authentication to ensure identity and document integrity, general electronic signatures are less secure unless combined with additional controls such as audit trails, secure access, and system validations – all of which are required under 21 CFR Part 11 for compliance.
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