• Official comment

    Thanks Fabio, great question!

    First a quick point of clarification: the certification for FDA or ISO 13485 is obtained by the companies using AODocs / AOQuality, not by AODocs / AOQuality themselves. In other words, it's not our software that is being audited for compliance, but it's "how your company uses our software" that can makes you compliant. 

    That being said, it is indeed our job to provide you with all the features you need to pass your FDA or ISO audit easily, and we have worked on this with multiple customers in the life science industry.

    Most requirements of FDA 21 CFR Part 11 and of ISO 13485 can be addressed with AODocs or AOQuality standard features, but the FDA requirements on electronic signature go a bit beyond what can be done in the standard AODocs workflows. To be fully FDA compliant, you will need a strong user authentication for the final validation of documents, which can be achieved either by using DocuSign (with our AODocs - DocuSign connector) or via custom integration with a third party authentication service. 

    If you are interested in learning more about this topic, we can organize a meeting with our services team. 


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  • Thank you, do you have a list of consultants that can help with implementing ISO 13485 through AoDocs ?

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