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PKS™ Features

Pharsight® designed PKS™ as a secure research management system specifically suited to the needs of clinical pharmacology and drug metabolism researchers. Key features include:

  • PKS Client desktop application for managing S-PLUS®, SigmaPlot®, SAS and NONMEM® analyses in PKS
  • Direct integration with WinNonlin and WinNonMix® for industry-standard PK and PK/PD modeling capabilities
  • Study Creation wizard to assist loading of study data via WinNonlin or the PKS Client
  • Web-based Query Tool to search, select and download study data
  • Web client administrative interface to archive, restore or lock and unlock data, and administer user permissions (system ADMIN users only)
  • PKS Connector to exchange data with other data management systems including Laboratory Information Management systems (LIMS), and other ODBC or JDBC compliant sources
  • Online Help system detailing setup, usage instructions and data requirements

Validation

The Pharsight Knowledgebase Suite was specifically designed to meet the regulatory compliance and validation needs of clinical pharmacology and drug metabolism groups.

Pharsight's products are widely used by pharmaceutical companies, academic and research institutions, as well as regulatory agencies. Several of these organizations have audited and approved Pharsight's software and development methods as suitable for use under their GLP, GCP, and GAMP compliance/standards. Pharsight's products are developed using standard, well-documented Software Development Life Cycle (SDLC) processes and procedures, to enable users of Pharsight's products to be GLP/GCP/GAMP compliant. Pharsight systematically validates its products as part of its software development and delivery process. But there is more to being GLP/GCP/GAMP compliant than simply buying well-documented, well-tested, well-developed software. GCP/GLP compliance also involves what users do after the purchase to validate the operation of the system within their environment and to use the software properly with written Standard Operating Procedures (SOPs).

21 CFR Part 11 Compliance

Pharsight has been working with our customers to help them achieve compliance with 21 CFR Part 11 (Electronic Records; Electronic Signatures; Final Rule) regulations. The Enterprise Editions of WinNonlin and WinNonMix were initial steps toward achieving this compliance, allowing users to read PK/PD data and save analysis results directly to/from any ODBC-compliant database which is protected by user login procedures (such as an Oracle database set up by the customer IT group).

Appropriate implementation of PKS, together with your Standard Operating Procedures, can achieve full compliance with 21 CFR Part 11. The PKS Suite uses electronic signatures and audit trails to store and manage PK/PD data and analysis results from WinNonlin, WinNonMix, and other analysis tools.

 

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