It is a standard. A standard you can build your quality management system up to. Or not. If you do you can have a TIC company come to approve that it complies with the standard.
The standard helps a company and it’s customers only in the sense that it can serve as common ground.
I would assume that big Pharma expect it as MINIMAL standard for any discussion. ADO should have had it since years!
But as it is not a company but a continued dog and pony show it of course was not necessary...
ADO Analysis, page-2241
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