To meet DSCSA Compliance Requirements in 2017, rfxcel staffed a designated team to address unique requirements and integrate with 50 trading partners.
Pharmaceutical Compliance and Regulatory Management
We were approached by a global pharmaceutical manufacturer in January of 2016. This company is composed of thousands of employees, billions of dollars in revenue, three global manufacturing sites and 50 contract manufacturing organizations (CMO’s) worldwide. Their team needed a reliable solution that could meet their unique business needs and one they could trust to scale in the future.
“It’s really not about connectivity. It’s about integration, and that each step in the process has equal need of attention,” said rfxcel CTO Atul Mohidekar “In this process, there are thousands of integration points. Customers need a partner that will take care of these integrations to meet compliance requirements.”
Key project requirements:
- Industry standard compliance and serialization functionality
- Meet all DSCSA Compliance Requirements 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 (ERP system), 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 can go live within six months in order to meet regulatory deadlines and internal project timeline
- Minimal up-front hardware and other capital expenditures and lower ongoing maintenance costs
“We have life changing products, big ideas and work with the biggest companies on the planet. And so we need tools to meet our ambition.” Customer Quote
With the Traceability Platform, Compliance & Regulatory Management and Serialization Processing, we were able to deliver customer requirements in less than 6 months.
rfxcel provides a sophisticated platform for streamlined data integration.
Product key points to successfully meet compliance requirement:
- Agile architecture to meet any serialization demand – The serialization software will 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. It will 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.
- Expansive global compliance offering – The Compliance and Regulatory Management solution provides comprehensive DSCSA Compliance Requirements, European Falsified Medicine Directive (FMD) and global compliance management solutions in one integrated platform to meet the most complex regulations and reporting requirements (both current and in the future).
- Ease of use – The intuitive user interface (UI) makes the rfxcel Traceability System easy for the entire organization to learn and use, regardless of corporate function or level of computer savviness. Users can even access and use the application on their smartphone.
- Scanning Capabilities – rfxcel’s solution supports the ability to add scanners to the solution without the need to purchase additional server or edge based hardware.
- 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 validation requirements of each customer. It enables each customer to be on their own version of rfxcel Traceability platform so there’s no application sharing or forced upgrades. This gives customers more control, reliability and security.
Learn more about DSCSA Compliance Requirements and other stories. Contact us to see how we can take the burden off your shoulders and support you through this process.