A
anderson2015
Good Afternoon,
We are currently working our way through our API plan and are looking into the design and validation element.
I understand that we need to provide a design pack to the auditor to ensure compliance with the relevant specifications such as 16C and 17K.
Is there a defined list anywhere that would tell us what we need to include?
If not, does anyone here have enough experience knowledge as to guide us in the right direction?
This is the one element I struggle with in particular as it is far different from any standard ISO requirement I have worked with in the past so any help would be greatly appreciated.
We are currently working our way through our API plan and are looking into the design and validation element.
I understand that we need to provide a design pack to the auditor to ensure compliance with the relevant specifications such as 16C and 17K.
Is there a defined list anywhere that would tell us what we need to include?
If not, does anyone here have enough experience knowledge as to guide us in the right direction?
This is the one element I struggle with in particular as it is far different from any standard ISO requirement I have worked with in the past so any help would be greatly appreciated.
