Beckman Coulter LS 13 320, User Manual

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PN B05577AC 4-4
Regulatory Compliance - 21 CFR Part 11
Electronic Record Control - 21 CFR Part 11
1
On the Administrator menu, click
Audit Trail Settings
.
2
Select the options in the dialog box and press
OK
.
NOTE
The dialog has a button marked
21 CFR 11
. When activated this ensures that options are set to
facilitate compliance with the regulations set forth in part 11 of the CFR volume 21.
Electronic Signatures
An electronic signature can be 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”. This means that an electronic signature is some computer
representation of a user's identity, developed to insure the distinct and unique identity of that user.
The use of electronic signatures as the “legally binding equivalent of traditional handwritten
signatures” then must be “certified” to the agency in writing.
Biometric and non-biometric forms of electronic signature are methods of verifying an individual's
identity based on an individual's physical feature(s) or repeatable action(s). Biometrics are
generally regarded as techniques such as fingerprints or retinal scans, which are considered to be
totally unique to each individual and require specific forms of scanning devices to read and
interpret. Non-biometric signatures are those that are computer generated and employ at least two
distinct identification components such as an identification code and password. It is this form of
electronic signature that is supported by the LS 13 320 software.