E
Enkidu
Hi,
Apologies if I'm asking a question that's already been answered. If so, any pointers an answer would be gratefully received.
I'm working with a manufacturer who is using an agile methodology to create class C medical device software. The organisation wants to ensure its QMS and practices are 62304 compliant. I'm supposed to be helping.
One of the issues I have is related to software tools. I'm struggling to understand the full extent of what's required to validate our configuration management software. What I'm finding hardest to understand is whether the tool needs to be on a dedicated server, how secure any server needs to be. Questions of that ilk.
Can anyone suggest where I might go for guidance? Or can anyone provide any guidance?
Any help gratefully received.
Apologies if I'm asking a question that's already been answered. If so, any pointers an answer would be gratefully received.
I'm working with a manufacturer who is using an agile methodology to create class C medical device software. The organisation wants to ensure its QMS and practices are 62304 compliant. I'm supposed to be helping.
One of the issues I have is related to software tools. I'm struggling to understand the full extent of what's required to validate our configuration management software. What I'm finding hardest to understand is whether the tool needs to be on a dedicated server, how secure any server needs to be. Questions of that ilk.
Can anyone suggest where I might go for guidance? Or can anyone provide any guidance?
Any help gratefully received.