PV Publisher

PV Publisher

PV Publisher tool provides end-to-end solution for aggregate reports processing and automation. It provides rich features for document co-authoring and review, and for delivery of high-quality documents.

Integration with content management solutions, auto-generation of submission ready reports based on templates, communication with regulatory authorities using E2B R3, eCTD format and an open architecture for plug and play with other applications makes it an easier choice for customers.

Key Features

  • One Stop Publishing Solution: Works with both PV and Clinical groups for end-to-end processing of aggregate reports and automation.
  • Design: Well-thought through design to take care of most of the pain points from the existing custom solutions used for aggregate reports processing
  • Template Based Reports – Supports commonly used word templates for worldwide market authorization holders and provides submission ready dossiers in PDF format with bookmark capability.
  • Configurable Workflow – Uses configurable workflow for managing the entire lifecycle of aggregate reports from planning, tracking report authoring, task distribution, submission, and generation of audit reports.
  • Rule-based output for different Countries – Ability to generate multiple reports from the single template based on country of submission and other parameters.
  • Compliance: Compliant with all Regulatory Guidelines
  • Use or Reference Previous Output: Comparison with previous report outputs and content reuse makes authoring and review of future reports a lot easier
  • Plug and Play: Plug and play by design to support data from standard PV systems and reporting sources

Key Benefits

  • End to End Reports Processing – Provides ease of use for report output generation, report authoring and review, sharing and publishing of reports.
  • Process Simplification – Streamlines & simplifies the document writing process for periodic report production.
  • Significant Cost and Time Saving with Automation – Automated process steps to get submission ready reports significantly faster resulting in cost and time savings.
  • Quality Improvements – Auto-population of contents and comparison with previous report outputs yield better quality submission ready reports.
  • Easy to Use – Intuitive, simple to operate the system with almost no training required.
  • Rapid Deployment: Leverage RxLogix implementation and validation package for faster implementation including support for hosted deployments.