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For further guidance on validation of computerized systems, see FDA's guidance for industry and FDA staff General Principles of Software Validation and also industry guidance such as the GAMP 4 Guide . We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity. For instance, validation would not be important for a word processor used only to generate SOPs. Focused Mcus Deliver High Performance For Industry 4 0 Apps Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. Part 11 signatures include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule (e.g. approved, reviewed, and verified). In March of 1997, FDA issued final part 11 regulations that prov