Phoenix WinNonlin Va.. - Pharsight Corporation

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Software Validation vs. Computer System Validation As a provider of software that is used by FDA-regulated customers, Pharsight Corporation develops software products in accordance with a documented software development life cycle (SDLC). In each of the phases of this life cycle, documentation deliverables are created, including Software Requirements Specifications, Design Specifications, Test Plans, Test Cases, and Traceability Matrices. These documents serve to document the development and testing of individual software products and contain proprietary information. At the end of the SDLC, Quality Assurance approval of the Release Approval/Validation Completion form completes Pharsight’s validation of the software product. Pharsight customers use Pharsight software products in the implementation of computer systems in FDA-regulated environments. To be compliant with FDA expectations, customers must validate the computer system, of which the software is but one component, along with the hardware (servers and workstations), network and operating systems environment, interfaces with other computer systems, and policies/standard operating procedures. Validation of the computer system must occur in the user’s environment and must account for the user’s unique set of user and functional requirements.
Computer System Validation - General Principles of Software Validation guidance document From a customer’s point-of-view, Pharsight software is not validated. In order to be compliant with FDA expectations, companies must validate computer systems, of which the software is but one component. Validation of the computer system must occur in the user’s environment and must account for the user’s unique set of user and functional requirements. “When the software is developed by someone other than the [user] (e.g., off-the-shelf software), the software developer may not be directly responsible for compliance with FDA regulations. In that case, the party with regulatory responsibility (i.e., the [user]) needs to assess the adequacy of the off-the-shelf developer’s activities and determine what additional efforts are needed to establish that the software is validated for the [user’s] intended use.” “The [user] is responsible for ensuring that the product development methodologies used by the off-the-shelf software developer are appropriate and sufficient for the [user’s] intended use of the software. The [user] should consider auditing the vendor.”
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: Validation Terminology - FDA Office
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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