SYS-CON MEDIA Authors: Noel Wurst, Liz McMillan, Sean Houghton, Glenn Rossman, Ignacio M. Llorente

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Ferndale Laboratories Selects rfXcel to Meet U.S. “Big Three” September 1 DSCSA Deadline

rfXcel, leader in Serialization, Traceability, and DSCSA and Global Compliance Cloud Solutions for the Life Sciences industry, announced today that Ferndale Laboratories, Inc. – part of the Ferndale Pharma Group, a privately held group of specialty health care companies with a 115-year history in pharmaceuticals and related markets – has selected the rfXcel Traceability SystemTM (rTS) to comply with the US Drug Supply Chain Security Act (DSCSA). Ferndale Laboratories is committed to supporting its customers in meeting the September 1, 2014 deadline to provide DSCSA Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS) on all products shipped to Big Three pharmaceutical distributor, McKesson, as well as the deadlines for Cardinal Health and other leading distributors.

rfXcel Traceability System is the most robust, production-ready DSCSA solution in the market

rTS is a comprehensive, validatable, private cloud solution for manufacturers, distributors and dispensers, to comply with the US Drug Supply Chain Security Act (DSCSA) – Title II of the US Drug Quality and Security Act (DQSA) regulations. rTS was first released for production in February, 2014. It is backed by the rfXcel compliance guarantee. Suppliers using rTS can be fully operational with production-proven DSCSA systems, and meet the DSCSA business and regulatory deadlines with confidence.

According to industry sources, suppliers are required to provide TI, TH, and TS to Big Three pharmaceutical distributor, McKesson, by September 1, 2014, as part of its DSCSA readiness plan. After November 1, 2014, shipments with incorrect TI, TH, and TS may be embargoed until correct data is received. After January 1, 2015, shipments will not be received into inventory and will be embargoed pending pickup by manufacturer. To reduce cost and complexity, the Big Three prefer TI, TH and TS to be sent electronically using EDI/ASN with EPCIS to follow. Cardinal Health has plans to impose financial penalties for TI, TH and TS submitted as paper documents. With 5 months left before DSCSA becomes law, suppliers relying on DSCSA solutions that are still in development or immature software releases not yet ready for production, compound their risk of missing critical Big Three deadlines.

“As a customer-centered CMO, Ferndale Laboratories is taking the lead in making it easy for our customers to comply with US DSCSA regulations. We are committed to meeting the production deadlines from the Big Three and other distributors to ensure that our customers have no disruptions in their commercial activities,” said Christopher Stein, Chief Operating Officer, Ferndale Laboratories, Inc. “We found rfXcel to be very knowledgeable in compliance, highly responsive to our needs, and very easy to work with. rfXcel was the only vendor with a fully working product, comprehensive DSCSA functionality, and a fully verified trading partner network for rapid onboarding. Without rfXcel, it would have been very challenging to be ahead of the curve and be a front runner in supporting our existing customers and potential new customers in meeting these aggressive DSCSA timelines.”

rfXcel is first to market with a complete DSCSA cloud solution

rTS was released to production in February, 2014, within 3 months of President Obama signing H.R.3204 – DQSA/DSCSA, making it the first production-ready cloud solution in the market. rTS is a fully automated, comprehensive, cloud application that is highly flexible and configurable. It is easy to implement, manage, use, and change as regulations evolve. rTS provides complete functionality out of the box for managing DSCSA compliance with a rich set of features that can be used to:

  • Provide transaction reports (TI, TH, and TS), in a single electronic document, to authorized trading partners (ATP).
  • Quarantine and investigate suspect products, and respond to requests for verification from ATP.
  • Identify and eliminate illegitimate products, and notify ATP and the FDA.
  • Provide serialization at all package levels, with hierarchy.
  • Verify serial numbers of suspect products.
  • Manage sellable and non-sellable returns.
  • Provide full product trace at all package levels.
  • Enable easy ATP onboarding via rfXchangeTM with high data accuracy.
  • Follow the latest industry standards, e.g. HDMA EDI ASN856 and GS1/EPCSIS1.1.

“Our forward-thinking customers, like Ferndale Laboratories, view the next three months as a critical window to harden their DSCSA solutions with full support from the Big Three. rTS is ready for deployment today. It is easy to implement, simple to use and fully meets the Big Three DSCSA business requirements, as well as, the broader DSCSA compliance requirements, out-of-the box,” said Glenn Abood, CEO of rfXcel. “rfXcel has on-boarded thousands of trading partners and clinics and therefore our integration is very mature and efficient. With most customers, we see that a majority of their trading partners are already on rfXchangeTM. Connecting new customers or incremental trading partners is routine, we get the data right, and rfXcel does not charge a fee for it.”

Trading partner onboarding on rfXchange™ is mature, efficient and free

rfXchange™ - rfXcel’s verified event network, is used by tens of thousands of trading partners and clinics to share compliance and traceability information every day. rfXchangeTM provides ‘plug-n-play’ integration of all trading partners through a single connection, regardless of the communication protocols or data formats used. The unique event verification technology in rfXchangeTM addresses the most critical issue in trading partner integration – data accuracy. rfXchangeTM supports DSCSA EDI/ASN extensions required by Cardinal, AmerisourceBergen and McKesson, making it easy for suppliers to meet their DSCSA requirements. The vibrant trading partner network on rfXchangeTM is nurtured by rfXcel’s veteran trading partner onboarding team, and provides easy connectivity with high data accuracy. This makes it easy for new customers and their trading partners to be rapidly integrated into rfXchangeTM with no data issues.

rfXcel DSCSA cloud solution can be fully validated by customers

rfXcel Traceability SystemTM is built on private cloud technology that can be fully validated as per our customer’s regulatory practices and timelines. DSCSA requirements are new and will evolve over time resulting in many changes to the software application. Transaction data (TI, TH, and TS) serve as a system of record for requests for information from the FDA, and need to be archived for 6 years as well as be readily available on demand. DSCSA serialization regulations affect manufacturing lines. These are key reasons customers require their DSCSA compliance solutions to be validated. rfXcel Traceability SystemTM is built on private cloud technology that can be fully validated as per our customer’s regulatory practices. Unlike multi-tenant solutions running on public clouds, rfXcel private clouds are tailored to meet the specific needs of each customer. rfXcel provides dedicated test, stage and production environments for each customer to validate the solution using company-specific validation processes including running load testing. Customers also get full control over the timing of software and equipment updates.

About rfXcel

rfXcel, founded in 2003, is headquartered in San Ramon, CA. rfXcel is a leader in Product Serialization, Traceability, and Compliance Cloud Solutions for the Life Sciences industry. rfXcel solutions are used to manage compliance with the US Drug Supply Chain Security Act (DSCSA), Title II of the US Drug Quality and Security Act (DQSA), as well as country-specific regulations for China, Brazil, India, Argentina, Turkey, Russia, South Korea, Europe and others. Leading manufacturers, distributors, packagers, and retailers rely on the rfXcel Traceability SystemTM (rTS) for traceability of ingredients and finished goods across the supply chain, and to increase market share, profitability, and patient safety. rfXcel’s Verified Event Network, rfXchangeTM, provides flexible integration with high data accuracy for tens of thousands of trading partners and clinics. rfXcel is a certified SAP and GS1 (EPCglobal) partner, and its solutions are HIPAA compliant. rfXcel’s production-proven, private cloud technology can be fully validated to meet our customer’s regulatory standards. The rfXcel management team and board are comprised of industry experts from life sciences with deep expertise in Cloud, Supply Chain, Data Management, ERP and Systems Integration. For more information, please visit www.rfxcel.com, or contact Jack Tarkoff ([email protected]) to discuss your specific needs.

About Ferndale Labs

Ferndale Laboratories is a Contract Manufacturer with over 40 years of expertise in semi-solid manufacturing and packaging, focusing on OTC and Rx topical products. With abilities ranging from small exploratory batches to full-scale 1,000kg batches, and packaging abilities from rigid bottles to tube filling, Ferndale Laboratories is a true contract manufacturing and development partner. Compliance with the DQSA is just an additional service to the full regulatory requirements that are offered to their customers. The Ferndale Laboratories contract manufacturing team has an excellent reputation with the FDA as well as other Regulatory Agencies and would welcome the opportunity to discuss your next project with you directly. For additional information, please visit http://ferndalelabsmfg.com, or contact David Buczko ([email protected]) for a complete evaluation.

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