Phoenix WinNonlin Validation Suite
As required by 21 CFR and ICH regulatory guidelines, computer systems used in the pharmaceutical industry must be validated to assure proper performance. As a result, companies often spend weeks of precious time performing computer system validation. Used by hundreds of customers, the Phoenix® WinNonlin® Validation SuiteTM is a desktop application that contains a set of detailed test scripts that accelerate the validation of Phoenix WinNonlin in a regulated environment. With it, users can:
- Automatically operate Phoenix WinNonlin in order to generate output
- Compare that output to standard known results
- Export the results to a Microsoft® Word® Run Report
Benefits
Meets compliance mandates
Ensure that Phoenix WinNonlin is functioning as intended.
Saves time
Automated test scripts allow users to complete testing in a day rather than weeks.
Provides users with control over testing process
The Phoenix WinNonlin Validation Suite allows customized test plans and/or test scripts (may require 3rd party tools).
Reduces validation effort
Test scripts, input datasets, reference output, and validation life cycle document templates are all included in the Phoenix WinNonlin Validation Suite.
Functionality :
- Automates testing using 200 test scripts
- Contains reference files for verification
- Provides documentation of activities by automatically generating a validation Run Report in Microsoft Word
- Includes customizable templates of validation life cycle documents
Complete your experience using Phoenix WinNonlin with the following tools:
• Autopilot Toolkit
• IVIVC Toolkit for Phoenix WinNonlin
• Phoenix WinNonlin Validation Suite
For more information or to purchase call or email sales@4amsoftware.com.au
Disclaimer : The information on this Certara product line including names of other Software products/companies and brands, customers, customer statements and application labels are information taken from the original developer's website. 4am Software makes no additional claims to the information contained. Furthermore 4am Software Pty Ltd., does not make any claims of performance of the products, links with other related products or industry standards limited to PK/PD analysis or beyond. The sole purpose of information is to provide customers complete details in making a decision to purchase the products.