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PKS™ Reporter Features

PKS™ Reporter is part of the Pharsight® Knowledgebase Suite™, specifically designed to meet the regulatory compliance and validation needs of clinical pharmacology and drug metabolism groups. Key features include:

  • Direct integration with the Pharsight Knowledgebase Server™ for secure, traceable links to validated data and analyses
  • Supports data and analyses performed in WinNonlin®, NONMEM®, SAS and other industry-standard software as well as report-ready tables and graphs generated by WinNonlin AutoPilot.
  • Provided as a Microsoft Word add-in to simplify deployment.
  • Support for pre-defined templates to standardize reports and speed report generation.
  • Content links to PKS data objects to flag out-of-date report content and update seamlessly to reflect the latest PKS data.
  • Signature tool to list, track and notify users who must sign the report, and storage of electronic report signature.
  • Online Help system detailing setup, usage instructions and data requirements.

21 CFR Part 11 Compliance

In combination with your SOPs and the Pharsight Knowledgebase Server, PKS Reporter can help you achieve full compliance with FDA regulation 21 CFR Part 11 (Electronic Records; Electronic Signatures; Final Rule).

PKS Reporter supports document authoring, review and approval using electronic signatures, reason for change capture, and comprehensive audit trails to store and manage Word documents containing PK/PD data and analysis results from WinNonlin Enterprise and other analysis tools. Analysis and modeling results are linked back to the underlying study data and changes to the data, such as rerunning analysis or loading additional data, cause the linked report elements to be marked for possible updates and review.

PKS Reporter can provide full versioning and audit trail control over finished reports, by using the capabilities of PKS to manage the report file along with all supporting data and analyses needed for a regulatory submission.

PKS Reporter and the Pharsight Knowledgebase Server are intended to be validated as a "closed system" compliant with Electronic Records; Electronic Signatures; Final Rule (21 CFR Part 11) and Guidance for Industry – Computerized Systems Used in Clinical Trials, deployed on a pharmaceutical R&D organization’s intranet.

 

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