Phoenix WinNonlin Va.. - Pharsight Corporation

Why Validate? - continued
The FDA offers a guidance document (a document which describes the
FDA’s current thinking on a topic, but which is not law):
General Principles of Software Validation; Final Guidance for Industry
and FDA Staff, Issued 11 January 2002 by the FDA Center for Devices
and Radiological Health
Because it makes good business sense by ensuring quality, timeliness, and
efficiency, and by effectively addressing business risks.
• “A documented requirements specification represents the user’s needs and
intended uses. The goal of computer system validation is to demonstrate that the
computer system meets all documented requirements.”
• “Computer system validation is a critical tool used to assure the quality of a
computer system. Validation can increase the usability and reliability of the
computer system. Validation can also reduce long term costs by making it easier
and less costly to reliably modify software and revalidate software changes.”