M&A: Regulatory Complaints System

M&A: Regulatory Complaints System

Overview

Traditional business models are always challenged, but nothing close to the scale we’ve seen in the last several months. At 5P, we have always been about accelerating a company’s Digital Transformation through the vast experience we have across our team and clients. Let’s take a look at a short case study to highlight the importance of transformation in today’s climate. 

 

SENTÉ, Inc. is a leader in high-end skincare products. They have had a sales and distribution process in place that was very effective at optimizing market exposure, getting products on shelves, and driving sales through their physician-dispensed sales channels. 

 

On March 18th, 2020, Governor Newsom announced that a quarantine would be put in place. Throughout the country, similar announcements were made, and just like that, we were all working from home, not attending social events, and avoiding non-essential locations to buy products. Immediately, we are all thrust into a new world and for many, completely uncharted territory on the impact on our businesses. 


What We Did

Together, the company’s Information Technology, Regulatory Organization, and 5P architected and delivered an industry solution. The solution streamlined and automated the unique FDA regulatory requirements process for medical device manufacturers. The partnership between the client and our rock star consultants led to a re-engineered FDA Regulatory Complaints Handling System


How We Did It

Salesforce Platform

5P expanded on client B’s Salesforce investment on the Sales process side and built a custom solution for the Service side of their business. By leveraging the platform, the client would benefit from an integrated solution across the company with shared master data, including customers, distributors, products, and sales. The user experience aligned with other tools the user community leveraged in their Salesforce CRM. At the end of the engagement, since Salesforce was already their CRM, the company would be positioned to support the solution with an integrated approach in their Information Technology team.


5P’s Salesforce experts architected and delivered a custom industry solution to support the entire business flow as depicted below. From a technical perspective, leveraging Salesforce’s platform allowed for the rapid delivery of functionally through available standard objects throughout the build. To fulfill the solution’s complex requirements, the team was challenged to deliver an extensive number of custom objects, multiple Visualforce pages, flows, processes, workflow automation, validation rules (both standard and Apex), approval processes, and a complex data security model. 


5P’s Lean Framework

Leveraging 5P’s ‘Lean Framework’, 5P partnered with the client’s organizations including Quality, Manufacturing, and Regulatory Affairs to design and deliver a custom solution to handle the client’s regulatory processes. 


5P’s LEAN Framework enabled our team to break down complex processes into delivery components in an Agile fashion. Additionally, our framework ensured clear requirements, design, as well as ensuring the user community’s involvement as change agents throughout the engagement. Most importantly when the engagement completed the user community was fully able to run their business and support the solution. The framework was built on the best of breed tools including Monday.comJira and 5P’s PM reporting framework which ensured visibility to the client throughout the engagement for alignment of solutions from activities, risks, and budget to actuals.

Business Process Workflows

Results

This industry-specific solution has unique requirements to manage FDA regulated and HIPAA compliant processes. Some of the key components of this solution include:

  • Supports international operations across 5 countries including the US, Europe, and Asia. 

  • Streamlines complex escalation and investigation between the case owners, technicians, regulatory representatives, and the FDA.

  • User experience aligned with the organization for simple-to-follow pages throughout the process. 

  • Automation for manual tasks including notifications and follow-up tasks.

  • Executive dashboards for monitoring case progression and complaints trending for product lines and international regions.

  • Delivered operations manuals for the various roles and training to ensure adoption. 

“At SENTÉ, we had a very effective physician-dispensed distribution model. The day the quarantine hit; this model experienced a severe impact as offices closed around the United States, so we had to pivot fast in order to execute a new Omni Channel business model moving forward. 5P worked with us to drive our digital transformation and re-engineered our system architecture and cloud solutions, which allowed our company to get back on track with our business now and moving forward. 5P’s expertise in system architecture, Cloud platforms, and data integration was critical in the success of our business.”

Learn More

5P is a Business Transformation Firm delivering solutions through process and technology. We are a Salesforce Certified Consulting Partner that delivers business and digital transformation initiatives on the Salesforce Platform. For more information reach out to us at info@5pconsulting.biz