Phoenix WinNonlin Va.. - Pharsight Corporation
Phoenix WinNonlin Va.. - Pharsight Corporation
Phoenix WinNonlin Va.. - Pharsight Corporation
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Why <strong>Va</strong>lidate? - continued<br />
The FDA offers a guidance document (a document which describes the<br />
FDA’s current thinking on a topic, but which is not law):<br />
General Principles of Software <strong>Va</strong>lidation; Final Guidance for Industry<br />
and FDA Staff, Issued 11 January 2002 by the FDA Center for Devices<br />
and Radiological Health<br />
Because it makes good business sense by ensuring quality, timeliness, and<br />
efficiency, and by effectively addressing business risks.<br />
• “A documented requirements specification represents the user’s needs and<br />
intended uses. The goal of computer system validation is to demonstrate that the<br />
computer system meets all documented requirements.”<br />
• “Computer system validation is a critical tool used to assure the quality of a<br />
computer system. <strong>Va</strong>lidation can increase the usability and reliability of the<br />
computer system. <strong>Va</strong>lidation can also reduce long term costs by making it easier<br />
and less costly to reliably modify software and revalidate software changes.”