Phoenix WinNonlin Va.. - Pharsight Corporation

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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.”
Why Validate? - continued Guidance for Industry: Computerized Systems Used in Clinical Trials - effective April 1999: VIII.B.1. - “The sponsor or contract research organization should have documentation (either original validation documents or on-site vendor audit documents) of this design level validation by the vendor, and should have itself performed functional testing (e.g., by use of test data sets) and researched known software limitations, problems, and defect corrections.” ICH regulatory guidelines - • Good Clinical Practice (GCP) (E6) • Statistical Principles for Clinical Trials (E9)
Page 1: Computer System Validation Discussi
Page 5 and 6: Validation Terminology - General Pr
Page 7 and 8: Validation Terminology - FDA Office
Page 9 and 10: Computer System Validation - Genera
Page 11 and 12: Validation Life Cycle Activities A
Page 13 and 14: Walk Through Phoenix ® WinNonlin
Page 15 and 16: What is the Phoenix ® WinNonlin ®
Page 17 and 18: Document Templates provided with Ph
Page 19 and 20: How It Works 2. If first time using
Page 21 and 22: How It Works 6. You can also set fi
Page 23 and 24: How It Works 9. When a Test package
Page 25 and 26: The Results Panel © Tripos, L.P. A
Page 27 and 28: The Show Log Panels © Tripos, L.P.
Page 29 and 30: The Summary Results Panel © Tripos
Page 31 and 32: (Optional) Test Plans 1. Optionally
Page 33 and 34: The Validation Suite Monitor The Va
Page 35 and 36: The Validation Suite Monitor The Va
Page 37 and 38: The Validation Suite Monitor Log ©
Page 39 and 40: Contacts & Follow-Up: Thank you! No

Phoenix WinNonlin Va.. - Pharsight Corporation

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