Moderator Note: Avoid multiple posts. It is confusing and therefore discouraged participationDear all,
I have a situation here. Any help on this will be highly appreciated.
Our firm is in USA and has decided to use a hybrid system for all 510k documents to be submitted to the FDA (although we have used digital signatures for every change made to the product throughout our product life cycle development)...our manufacturing and document preparation facility is out of USA, in country A.
In order to implement the hybrid system....our firm in USA will ask its employees in country A to take print outs of revision history of every 510k submission document like the risk management plan document etc....and then we will want the employees in country A to sign revision history of each document and send it over to the firm in USA. Here the revision history of each document can be attached with the respective documents and submitted to the FDA. Is this process of implementation correct? or is there any pitfall in it?
Finally, what exactly is the difference between electronic and digital signatures? Which one should be preferred for compliance with 21 cfr part 11.
Thanks in advance
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