Phoenix WinNonlin Va.. - Pharsight Corporation

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How Do I Perform Computer System Validation? 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: Applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. Based on generally recognized software validation principles and, therefore, can be applied to any software. No final guidance documents issued by CDER or CBER. Outlines a Validation Life Cycle similar to a Software Development Life Cycle: “[Customers] should develop a validation life cycle model that is appropriate for their computer systems and organization.” Validation activities will be governed by a customer’s Corporate Quality System Policy, Corporate Validation Policy, System Implementation Policy, etc.
Validation Life Cycle Activities A typical validation life cycle would include the following activities, with associated deliverables: • Validation planning - Validation Plan*, aka Validation Master Plan, Project Plan, System Plan, others? • Requirements definition – Requirements Specification*, aka User Requirements Specification, Functional Requirements Specification, System Requirements Specification, others? • Design definition – probably not applicable for PHX WNL, Connect, NLME • Configuration/construction of custom code – probably not applicable for PHX WNL, Connect, NLME • Testing (User Site Testing, aka System Testing, Functional Testing, Site Validation, Installation Qualification, Operational Qualification, Performance Qualification, Installation Testing, Installation Verification, User Acceptance testing, Site Acceptance Testing, Validation Testing, others?) - Test Plan*, aka Installation Qualification Protocol, Operational Qualification Protocol, Performance Qualification Protocol, Validation Protocol; Test Scripts**, aka Test Cases; Run Report***, aka Testing Summary Report, Installation Qualification Report, Operational Qualification Report, Performance Qualification Report, others?; Traceability Document, Traceability Matrix. • Implementation - Validation Summary Report*, aka System Acceptance Report, others? * - template included in the Validation Suite ** - test scripts, mostly automated, included in and executed by the Validation Suite *** - produced by the Validation Suite after execution of test scripts
Page 1 and 2: Computer System Validation Discussi
Page 3 and 4: Why Validate? - continued Guidance
Page 5 and 6: Validation Terminology - General Pr
Page 7 and 8: Validation Terminology - FDA Office
Page 9: Computer System Validation - Genera
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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