Document Control Software recommendations for Part 11 medical device

P

potato124

#1
Hello,

I have been involved with multiple med device companies who hate their document storage solutions. I am with a startup and will implement our first Part 11 compliant doc control system. Does anyone know of a 1)low cost, and 2)simple to use method? I would like the system to control documents, record and report manufacturing data, and be as "nimble" as possible....I would ideally use a programmable database, but which are compliant with Part 11?
 
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#2
How big is the company? How many total documents?
 
P

potato124

#3
Right now we are an army of 2. We are working on setting up a design control system, and a quality system for manufacturing med devices. We will have key suppliers, so supplier qualification will be a part of it as well.
 
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