USDM qualified Renovia’s GxP use of Salesforce and enabled case objects to be integrated into the complaint-handling solution.

Renovia’s innovative FDA-cleared medical devices and state-of-the-art patient-based app provide patented technology, micro-sensors, and Bluetooth communications designed to deliver enhanced value-based care, track progress, and reinforce compliance and adherence to care.

The Situation
  • Renovia had a three-month deadline to meet a critical go-live date for a national product launch.
  • Renovia had already implemented Salesforce for non-regulated use and wanted to maximize its functionality for GxP-related use but lacked the internal bandwidth.
  • They also required validation of their complaint-handling system that was integrated with their Salesforce and Propel PLM systems.
  • The IT team had a unique business requirement to provide a separate Salesforce instance for operational qualification (OQ) execution after dry runs were completed, which required additional dry-run testing.
  • Requirements, configuration documentation, and OQ use-case testing were delayed by the third-party vendor responsible for designing and configuring the complaints case object and required fields in Propel, further crunching the already tight project timeline.
The Solution
  • By deploying their proprietary Validation Accelerator Pack (VAP) templates for Salesforce Service Cloud, USDM qualified Renovia’s GxP use of Salesforce and enabled case objects to be integrated into the complaint-handling solution.
  • USDM’s VAP templates enabled rapid qualification to meet the aggressive deadline.
  • USDM created the following deliverables during the initial qualification phase:
    • Qualification Plan (QP)
    • System Requirements Specification (SRS)
    • Risk Assessment (RA)
    • Installation Qualification (IQ) Protocol
    • Operational/Performance Qualification (OQ/PQ) Protocol
    • Traceability Matrix (TM)
    • Qualification Summary Report (QSR)
  • USDM’s validation approach enabled Renovia to launch a new Salesforce instance with an integrated contact center on time, allowing them to maximize the ROI of their Salesforce investment and include GxP uses.
  • USDM’s solution improved operational efficiency allowing the call center to handle double the call volume with the same headcount.
  • This solution empowers Renovia to focus on their patients and achieve greater positive outcomes and allows them to respond in a customer-centric manner that is based on reliable, data-driven actions.

“Ten weeks of intense execution resulted in the launch of a new Salesforce instance with an integrated contact center technology for running RWC. Thank you for the incredibly hard work of everyone in bringing these systems to fruition.” ~ David Millard, Director, Commercial Applications
 

3 months to successful Salesforce qualification including PLM integration

Handled double the call volume with the same headcount

Maximized ROI on existing technologies to include GxP-related use

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