PV Risk Manager

PV Risk Manager

A robust Risk Management solution centralizing and tracking your Risk Management Plans integrated with our award-winning PV Signal and PV Reports products. Yet another Industry first solution from RxLogix.

Key Features

  • Holistic view of product safety profile, with emphasis on identified and potential risks and also on safety concerns which need to be managed proactively.
  • Creation and management of risk management plans for all the topics associated with a product.
  • Ability to configure templates based on pre-defined contents and auto-population of those template for the generation of risk plans.
  • Configurable workflow for authoring, review and update of risk plans along with version control capability to compare multiple versions of risk plan.
  • Integrated reporting for all kind of ad-hoc reporting on product safety profile and reports based on meta-data from the system.
  • Capability to integrate with companies document management systems for managing access, links and interfacing systems to safety reference documents.
  • User-defined checklist for finalizing risk plan and generation of submission ready contents for inclusion in aggregate reports.
  • Auto notification for indicating progress and delays in managing the risk profile of products.
  • Easy searching, sorting, task management and creation of user-based to-do lists for managing different view based on topics classification or risk categories.

Key Benefits

  • Flexible User-Friendly Interface – Provides flexibility to have standard and configured fields to enter and maintain the product safety summary/planning/safety strategy, safety risk and commitments information.
  • End to end RMP/REMS Management – Provides a user-friendly IT System environment to author, review and approve the RMP/REMS. No need to manage the contents in MS Word and SharePoint systems.
  • Product Profile – Provides an integrated safety profile of the drug where all relevant information is available at one place.
  • Automated Emails Alerts and Notifications – Provides ability to receive email alerts and online notifications, no need to actively monitor to-do lists.
  • Reporting and Metrics – Provides standard reporting capability on all the available Risk Management data.
  • Role-based centralized work environment for Safety Scientists and Physicians – Provides integrated and centralized environment linking all Risk Management-Signal Management-Aggregate Reporting-Data Analysis activities.
  • Workflow and To-Do Lists – Provides a very user-friendly way to configure and manage workflow for RMPs, Safety Strategy Plans, and Safety Topics and the associated user and/or role-based to-do lists, internal and external commitments.
  • Integrated PV Publisher – Provides authoring/publishing capabilities to create medical information contents.
  • Standard Interfaces – Provides out of the box integration with Document Management System and the ability to integrate with other applications.
  • GxP and 21 CFR Part 11 Compliance – Provides full compliance with GxP and 21 CFR Part 11 requirements.