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Digitalization of documents - FDA and ISO 13485

#1
Hi All, we are a medical device company currently in planning stages for the implementation of a process to digitalize all of our QMS, IP, HR, Regulatory documentation that we have been storing paper copies of for years. The plan is to validate a process to do this and once each document is verified we scrap the original. We will then only have certified records in our cloud. Can anyone see any issues with this process - we are FDA, ISO 13485 and ship worldwide. Does anyone know of documents that we must keep an original copy of or if we need to keep originals for a certain period of time before we scrap? I am talking about design files, V&V, job files, complaints etc, IP, Tech files etc? You name it, we will scan it. Thanks in advance!
 
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