Phoenix WinNonlin Va.. - Pharsight Corporation

Why Do I Need to Validate WinNonlin (or anything else)?
21 CFR Parts 210 & 211 - cGMP regulations, effective in the 1960’s:
211.68(a) - “Computers….shall be routinely calibrated, inspected, or
checked according to a written program designed to assure proper
performance.” 211.68(b) - “[with computerization or other automated
processes], a written record of the program shall be maintained along
with appropriate validation data.”
21 CFR Part 820 - Quality System regulation (applicable to software used in
devices and any part of the quality system) effective 01 June 1997:
“When computers or automated data processing systems are used as part
of production or the quality system, the [user] shall validate computer
software for its intended use according to an established protocol.”
21 CFR Part 11 - Electronic records, electronic signatures regulation effective
20 March 1997: 11.10(a) - Computer systems used to create, modify, and
maintain electronic records and to manage electronic signatures must be
“validated to ensure accuracy, reliability, consistent intended
performance, and the ability to discern invalid or altered records.”