If I understand the question correctly, yes. The design should be approved prior to development, otherwise how do you know you are developing the...
Yes, I am familiar with that kind of system - we had workflows for approvals in an electronic documentation system at my prior (much larger)...
How are approvals to documents going to be recorded in your new system? Do you have a company policy that electronic signatures are the equivalent...
The FDA has recently modified the list of standards the Agency recognizes for use in premarket reviews (FDA Recognized Consensus Standards). Most...
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