Guest user Created: Mar 25, 2020 Last commented: Mar 30, 2020

Electronic signatures

Hello, I was wondering if you have workflows and electronic signatures for the 13485 module and if they are 21 CFR 11 compliant.

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Kristina Zvonar Brkić Mar 30, 2020

Certain procedures in our ISO 13485:2016 toolkit have described workflows (eg. customer complaint process, sales process, evaluation of suppliers). Workflows are not mandatory according to the ISO 13485:2016.

Advisera does not provide software for ISO 13845, therefore we do not have electronic signatures. The ISO 13485 Documentation Toolkit is only a set of documentation templates, this is not a software.

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Mar 25, 2020

Mar 30, 2020

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