Challenge: Qualify Salesforce for GxP Use Against a National Launch Deadline
An FDA-cleared medical device company built innovative devices and a state-of-the-art patient-based app using patented technology, micro-sensors, and Bluetooth communications to deliver enhanced value-based care, track progress, and reinforce compliance and adherence to care. With a national product launch on the calendar, the company faced a hard set of constraints:
- A three-month deadline to meet a critical go-live date for a national product launch.
- Salesforce was already implemented for non-regulated use, and the company wanted to maximize its functionality for GxP-related use but lacked the internal bandwidth.
- The company required validation of its complaint-handling system, integrated with its Salesforce and Propel PLM systems, in line with 21 CFR Part 11 expectations.
- 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. Coordinating dependencies of this kind is a core element of third-party risk management in life sciences.
Approach: Cloud Assurance Validation Templates for Salesforce Service Cloud
By deploying its proprietary Cloud Assurance validation templates for Salesforce Service Cloud, USDM qualified the company's GxP use of Salesforce and enabled case objects to be integrated into the complaint-handling solution. Cloud Assurance enabled rapid qualification to meet the aggressive deadline while preserving data integrity across the integrated systems.
During the initial qualification phase, USDM created the following deliverables:
- 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 risk-based validation approach enabled the company to launch a new Salesforce instance with an integrated contact center on time, allowing it to maximize the ROI of its Salesforce investment and include GxP uses. To keep the system compliant after go-live, the company subscribed to USDM's Cloud Assurance service to offload the ongoing testing and validation maintenance of Salesforce cloud updates and patches.
Results: On-Time Launch and Double the Call Volume
USDM's solution improved operational efficiency, allowing the call center to handle double the call volume with the same headcount. This empowered the company to focus on its patients, achieve greater positive outcomes, and respond in a customer-centric manner based on reliable, data-driven actions.
- 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
By pairing a validated, integrated complaint-handling solution with ongoing continuous compliance, the company turned a compressed three-month timeline into an on-time national launch and a contact center that scales without adding headcount.
“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