Update from yesterday... The IT quality person has not found the document that explains what she does and how she reaches her decisions.
Unbeknownst to her, I have found it and am ready to tear her decision apart as soon as she finds it.
She will declare the project GAMP5, and medium risk.
I will argue that at most it's GAMP3, except it's nothing to do with GAMP ratings as it's not a project related to manufacturing.
And risk is zero, except on her scale you can only have low (but not zero) risk, medium or high.
Unbeknownst to her, I have found it and am ready to tear her decision apart as soon as she finds it.
She will declare the project GAMP5, and medium risk.
I will argue that at most it's GAMP3, except it's nothing to do with GAMP ratings as it's not a project related to manufacturing.
And risk is zero, except on her scale you can only have low (but not zero) risk, medium or high.
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