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.

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