Global Pharmaceutical Manufacturer

Background

A global pharmaceutical manufacturer needed a global compliance and serializa-tion solution – and fast! With the DSCSA and other global regulation deadlines quickly approaching, this manufacturer saw their solution provider withdraw support for the program and was scrambling to find a solution that would help get them compliant. With thousands of employees, billions in revenue, 3 global manu-facturing sites and the utilization of 50 contract manufacturing organizations (CMO’s) worldwide, an organization of this size can often spend a lot time just try-ing to find a solution that meets the entire organization’s needs, let alone make a quick decision. Time was not on their side.

 

The Challenge

This large, global manufacturer with many stakeholders needed to solve what would be a long-term program commitment in a very short period of time. Their initial strategy was to implement a company-wide, multi-project compliance and serialization solution with their incumbent vendor. Midway through the program, however, their solution provider decided to withdraw support for the serialization and compliance solution. They could have waited for a new solution their provider was in the process of developing, but deemed the risk to be too great.
The project was complex without the trouble of having to replace the incumbent solution provider, but the newly selected vendor had the additional task of implementing a new solution in a 6 month time frame, significantly less than the three year head start the incumbent vendor had. Timing was critical, and the new project also needed to come in on a limited budget as the capital expenditure budget was capped. Above all, the new solution provider needed to meet the key project requirements:

  • Have the same (or more) functionality than the current compliance and serialization solution offered
  • Meet all DSCSA and global compliance regulations, including country-specific reporting capabilities
  • Scalable architecture to handle serialization data for over 3,000 SKU’s, including the ability to aggregate serial numbers
  • Flexible framework to integrate with SAP (their ERP system), their network of 50 global CMO’s and multiple third-party logistics providers (3PL’s)
  • Easy way to connect and share data with trading partners
  • Ability to validate system and have control over software updates
  • Easy to learn and use the system, given the number of employees and contractors who would use it across multiple sites and manufacturing locations
  • Fully operational system tested and live within 6 months in order to meet regulatory deadlines and internal project timeline
  • Minimize up-front hardware and other capital expenditures and lower ongoing maintenance costs

The core team developed a systematic approach to find a vendor who could help them get their project on track, and do so in a hurry. Through a rigorous vetting process, the team identified vendors and invited each in for a grueling full day working demonstration of their solutions. The team knew finding a new solution midway through an existing project wouldn’t be easy. But one vendor clearly stood out: rfXcel.

 

The Solution

Not only was rfXcel able to deliver on the project requirements, they earned the trust from a team that was already skepti-cal they could find a vendor who could meet their stringent requirements and tight timeline. The team needed a reliable solution that met the unique needs of their business—and one they can trust to grow with them in the future. They ulti-mately chose the rfXcel Traceability System with the rfXcel Compliance Management (rCM) and rfXcel Serialization Pro-cessing (rSP) applications activated to deliver the many expected (and unexpected) benefits:

 

  • Agile architecture to meet any serialization demand – The rSP application can create, manage, allocate and store hundreds of millions of individual and aggregated serial numbers to provide more visibility and control, something that’s critical to the manufacturer as they look to serialize and aggregate more than 3,000 SKU’s.
  • Expansive global compliance offering – The rCM application provides comprehensive DSCSA and global compliance management solutions in one integrated platform to meet the most complex regulations and reporting requirements (both current and in the future), to provide peace of mind and simplify country-specific compliance needs.
  • Ease of use – The intuitive and logical user interface (UI) make the rfXcel Traceability System easy for the entire organi-zation to learn and use, regardless of corporate function or level of computer savviness. Users can even access and use the application on their smart phone.
  • Flexibility – rfXcel’ s flexible architecture allows it to integrate with any ERP system, including SAP.
  • Visibility and serialization – rfXcel provides unit-level and hierarchy serialization for enhanced visibility and control of product throughout the supply chain, and can easily scan, commission and aggregate serial numbers with scale. More importantly, rfXcel can manage and allocate serial numbers to an unlimited number of CMO’s, 3PL’s, manufacturing facilities, packaging line systems and government entities around the world.
  • Financial flexibility and lower cost to operate – With its SaaS model, the time and cost of implementation and ongo-ing maintenance is lower since no special hardware is needed and nothing needs to be deployed and managed on premise. Moreover, because the solution is hosted, the time to implement is also dramatically reduced.
  • Ultimate control – The rfXcel solution is built on private cloud technology, which allows each customer system and implementation to be fully validated and is tailored to meet the unique specifications and requirements of each cus-tomer. It enables each customer to be on their own version of the rfXcel solution so there’s no application sharing or forced upgrades, giving customers more control, reliability and security.

 

The Results

rfXcel stood out not only because of the benefits derived from the product, but because they were able to deliver….in a very short period of time.

  • Ultimately saved the compliance/serialization program after the incumbent solution provider abruptly stopped support-ing the solution
  • Launched the rfXcel Traceability System (rTS) in 6 months, meeting the company’s timeline and internal delivery mile-stones. rTS connects and shares information with CMO’s and other trading partners, handles country-specific compliance reporting requirements and will be managing and allocating hundreds of millions of serial numbers
  • Delivered significant capital expenditure savings by minimizing hardware, software application and ongoing maintenance costs and provided the organization with more predictable program expenditures for budgeting purposes
  • Provided framework for rapidly integrating and sharing data with key CMO’s and other trading partners
  • Integrated rfXcel Traceability System with the company’s SAP ERP and Warehouse Management solutions
  • Trained end users at each manufacturing facility and warehouse within 30 days of implementation