A
§820.30(d) Design Output Release - Before or After Verification?
Hello,
If this is a no-brainer to you, then I apologize upfront
but it so happens that I am a bit puzzled right now by the requirements of FDA 21 CFR §820.30(d):
Design output obviously needs to be documented, reviewed and approved before release (or transfer to the next design phase, I assume). How does this relate to verification in terms of timeline? Since I need to ensure that my output is meeting the design input requirements I established, is it not appropriate to initiate verification activities on this specific output BEFORE I approve the output? If this is not the intent, what is the value-add or purpose of approving design output before release?
My company currently maintains a strict separation between approval of design output and verification activities.
Thanks for sharing your thoughts!
Hello,
If this is a no-brainer to you, then I apologize upfront
Design output obviously needs to be documented, reviewed and approved before release (or transfer to the next design phase, I assume). How does this relate to verification in terms of timeline? Since I need to ensure that my output is meeting the design input requirements I established, is it not appropriate to initiate verification activities on this specific output BEFORE I approve the output? If this is not the intent, what is the value-add or purpose of approving design output before release?
My company currently maintains a strict separation between approval of design output and verification activities.
Thanks for sharing your thoughts!