PKS Validation Suite

Streamline the Validation of Your PK/PD Clinical Data Repository: Get Through Validation to Compliance Quickly

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. The Phoenix® Knowledgebase Server (PKS™) Validation Suite™ is a desktop application that contains a set of document templates, test data, and automated test scripts that accelerate the validation of PKS in a regulated environment. Even when using PKS Online—which already saves most of the validation effort—the remaining task of validating the correctly functioning access from your user’s desktops to PKS Online is significantly reduced. With the PKS Validation Suite, users can:

  • Automatically operate PKS 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 PKS is functioning as intended

Saves time
Automated test scripts allow users to complete testing in a day rather than weeks

Facilitates the testing process
The PKS Validation Suite features an easy-to-use graphical user interface to select and run tests and generate reports

Reduces validation effort
Test scripts, input datasets, reference output, and validation life cycle document templates are all included in the PKS Validation Suite

Functionality

The PKS Validation Suite includes:

  • Test data to be loaded by automated test cases
  • Automated testing of access to PKS using Phoenix WinNonlin
  • Test scripts for 3rd party products supported by Phoenix, such as SAS, S-Plus, NONMEM, and R
  • Manual test scripts for customer dependent features, such as password security and data migration from previous versions of PKS
  • Templates for the follow documents: Validation Plan, Test Plan, Requirements Specification, Traceability Document, and Validation Summary Report
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