USDM helps achieve faster approvals using Salesforce
Learn how USDM accelerated the digital transformation of a large medical device manufacturer by using Salesforce GxP capabilities to build custom applications, enhance existing processes, and streamline fragmented workflows.
USDM engaged with the customer on three progressive projects and continues to enhance the customer's implementations of Salesforce with new functionality and new processes while maintaining continuous compliance. USDM started small with a validation project—helping with the compliance strategy to cost-effectively use Salesforce globally—and then expanded to application development for the customer for multiple releases and enhancements, ultimately expanding to roll out a global application.
The Challenge
Outdated workflows and systems often cause delayed approvals and flawed data quality for life sciences companies. For this Fortune 500 medical device manufacturer with 15,000 products sold worldwide, those problems had compounded over years and across acquisitions.
- A legacy on-premise QMS application, MS Excel, email, and paper-based processes caused approvals to take over a month and created poor data quality
- A very complex custom approval process ran throughout the organization
- Siloed GxP processes and data management were amplified by ongoing M&A activity—a recurring source of data integrity risk
- Existing software licenses were excessively expensive
- The customer was already using Salesforce for other non-GxP processes, but had no validated, 21 CFR Part 11 compliant path to bring regulated workflows onto the platform
The Approach
USDM engaged in three phases of work with the customer for more than three years, starting small with validation and expanding to a global rollout—each phase delivered with continuous compliance in mind.
Phase 1 — Build and validate on Salesforce GxP
USDM quickly built and validated custom applications using Salesforce GxP capabilities, enabling the customer to replace two paper-based processes while maintaining compliance with Cloud Assurance for Salesforce (Product Release and Product Notice of Change).
- Product Release Application
- Created a custom approval process leveraging Salesforce Apex
- Created a clear UI so users could see what approval stage a record was in and who was responsible
- Notice of Change Application
- Defined a clear process outlining who should be notified of product changes
- Defined a list of product change types that users could select
- Leveraged Salesforce Apex to notify the proper parties with the click of one button
- Created a custom "product SKU loader" enabling Excel or text documents to be easily added to the Notice of Change record
- USDM integrated product data from three different systems to provide current registration updates
- USDM delivered mobile-ready Salesforce GxP applications with enterprise reporting and collaboration
- USDM established a "Validated Cloud Center of Excellence" for change management and centralized system administration
- The customer was able to roll out new workflows within weeks, not months
Phase 2 — Consolidate into a custom RIM solution
- The customer had been engaged with another consulting firm that was not meeting expectations and brought USDM back in to correct the project
- USDM integrated and enhanced Roadmap—a product registration and license tracking application—with the Product Notice of Change application to create a custom RIM solution
- USDM consolidated, cleansed, and loaded data from several applications into Roadmap
Phase 3 — Scale a Part 11 compliant solution across the merged company
- The customer was acquired and had too many siloed product tracking systems
- USDM was hired again to deploy the RIM solution for Notice of Change and Roadmap Product Registration to the broader, newly merged company
- USDM leveraged Salesforce Apex and Visualforce to create a custom Part 11 compliant audit trail
- USDM used Salesforce Batch to execute Apex asynchronously, allowing the code to scale with the data
The Results
By moving regulated workflows onto a validated Salesforce platform, the customer turned a month-long, paper-based bottleneck into a fast, auditable, single-system process—while taking significant cost out of the business.
- $750K saved annually from license, administration, and time savings in year one
- 85% reduction in software license expense in year one
- Paper-based processes replaced by electronic records, accessible from any web browser, propelling the customer's digital transformation
- Product data from several legacy systems migrated to a single platform
- The complex, global process of registering and licensing medical devices streamlined into a single application
Because the applications were built and maintained under Cloud Assurance, the customer didn't have to choose between speed and compliance—new releases and enhancements ship continuously while the validated state is preserved.
Learn more about USDM's digital transformation solutions for the medical device industry, or talk to a USDM expert about modernizing your GxP workflows on Salesforce.