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Electronic Records, Electronic Signatures
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Course Excerpt: The example above is an example slide from Unit 3 of the course. The diagram on this slide represents the processes of affixing an electronic signature to a file and subsequently verifying that the signature is correct.
The example is based upon the requirements of the fictitious company described in the case study that is used throughout the course. This company accommodates raw material variability by analyzing raw material lots and adjusting product formulas accordingly. The analysis and formulation tasks occur at different sites: one in the U.S. and one in the U.K.
The formulae are delivered as executable computer commands for a process control system. Because of the requirements of Rule 11, the company requires non-repudiatable documentation that each specific lot of material was produced with its correct and unaltered formula.
Working from this slide, the instructor describes a protocol for using commercial authentication software to provide the "electronic signature" as required by FDA Rule 11.
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