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 Cloud Assurance validation 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 Cloud Assurance 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.
- Renovia subscribed to USDM’s Cloud Assurance service to offload the ongoing testing and validation maintenance of Salesforce cloud updates and patches to maintain their compliant state.
- 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.
The Results
- 3 months to successful Salesforce qualification including PLM integration
- Increased IT capacity by offloading Salesforce validation maintenance to USDM
- Maximized ROI on existing technologies to include GxP-related use
“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