Phoenix WinNonlin Va.. - Pharsight Corporation
Phoenix WinNonlin Va.. - Pharsight Corporation
Phoenix WinNonlin Va.. - Pharsight Corporation
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<strong>Va</strong>lidation Misconceptions - General Principles of Software<br />
<strong>Va</strong>lidation guidance document<br />
“I can’t use validation information from a vendor” - “A [user] may<br />
conduct a validation using their own personnel or may depend<br />
upon a third party such as the equipment/software vendor or a<br />
consultant. In any case, the [user] retains the ultimate<br />
responsibility for ensuring that the software is validated.”<br />
“I have to validate all of the functionality in a product” - “A [user]<br />
“I have to validate all of the functionality in a product” - “A [user]<br />
who chooses not to use all the vendor-supplied capabilities of the<br />
software only needs to validate those functions that will be used<br />
and for which the [user] is dependent upon the software results as<br />
part of production or the quality system.
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