Phoenix WinNonlin Va.. - Pharsight Corporation

Computer System Validation - General Principles of Software
Validation guidance document
From a customer’s point-of-view, Pharsight software is not validated.
In order to be compliant with FDA expectations, companies must validate computer
systems, of which the software is but one component. Validation of the computer
system must occur in the user’s environment and must account for the user’s
unique set of user and functional requirements.
“When the software is developed by someone other than the [user] (e.g., off-the-shelf
software), the software developer may not be directly responsible for compliance
with FDA regulations. In that case, the party with regulatory responsibility (i.e.,
the [user]) needs to assess the adequacy of the off-the-shelf developer’s activities
and determine what additional efforts are needed to establish that the software is
validated for the [user’s] intended use.”
“The [user] is responsible for ensuring that the product development methodologies
used by the off-the-shelf software developer are appropriate and sufficient for the
[user’s] intended use of the software. The [user] should consider auditing the
vendor.”