Month: August 2017

Verizon Extends Healthcare Focus to Pharmaceutical Sector with rfxcel

Verizon extended its healthcare focus to now include the pharmaceutical and life sciences industries, the company is helping to transform the delivery of healthcare in the U.S. through a growing portfolio of IT solutions, unveiled two new industry-specific solutions designed to help companies keep up with increasing regulatory requirements for this sector.

Available immediately in the U.S. and Europe, Verizon is launching a portfolio of GxP (Good x Practices) Services for managing sensitive clinical and drug manufacturing data in the Verizon cloud or from select data centers. The company also entered into a partnership agreement with rfxcel whereby Verizon will provide its complementary cloud and data center service options to clients. rfxcel provides a serialization solution that helps companies track and trace pharmaceuticals from manufacturing to distribution.

“Companies within the sector are struggling today to meet growing regulatory requirements,” said Rich Black, vice president of Verizon’s healthcare practice. “We have found that our IT infrastructure which leverages our cloud, security and technical expertise can enable them to address this burden. We recently met with several large pharmaceutical companies and they were energized to learn that Verizon’s infrastructure services can be used to address what is clearly a pain point for them.”

Five Ways GxP Benefits the Pharmaceutical Industry

Verizon’s GxP services include colocation, managed hosting, and enterprise cloud solutions in three of the company’s premier global data centers, as well as professional services to size/scope the architecture and enable deployment. Verizon’s GxP services are helping companies to take advantage of:

• Geographic Coverage: Locations in North America (Culpeper, Va. and Miami, Fla.), and Europe (Amsterdam)
• Foundational Security: GxP services come with a baseline ISO 27001 certification
• Quality Management: Are managed under Verizon’s Quality Management Program to deliver qualified infrastructure with appropriate sign-offs on standard operating procedures and to ensure proper training, policies and document/record control
• Agility Enablement: Framework provides options to manage rapid growth, support alternative cost models (OPEX versus. CAPEX) and help accelerate new market expansions
• Focus on Core Competencies: Enables the outsourcing of existing non-strategic systems to free up internal resources for strategic initiatives

rfxcel Solution Provides Efficient Way to Track and Trace Drugs

rfxcel, a leader in cloud-based software applications, provides an efficient and cost-effective solution for tracking and tracing drugs throughout the supply chain, while reducing risk to patients through exposure to counterfeit drugs. Available to clients through rfxcel, this solution is a complete end-to-end service with compliance reporting that uses RFID and a 2D barcode that can be easily integrated into current ERP systems. The rfxcel solution offers serialization; traceability; alerts and notification; error detection and correction; and inventory management capabilities as well as an easy-to-use Web portal.

Verizon Delivers Comprehensive Set of Health IT Solutions

Verizon provides an array of health IT solutions that can be leveraged to address some of the biggest challenges facing healthcare systems today, including the ability to securely and efficiently exchange sensitive data across hospital, payer and physician networks via voice, video and data. This includes interconnected cloud, mobility, machine-to-machine and security solution sets including Universal Identity Services with Safe BioPharma.

Latest Product Enhancements Accelerate Product Leadership Position

San Ramon, CA January 20, 2017 – rfxcel, the leader in serialization, traceability, and DSCSA and global compliance in the private cloud for the Life Sciences industry, today announced the release of the latest edition of its compliance and serialization platform that furthers its product leadership position.  The latest product release dramatically improves scalability to handle hundreds of millions of serial numbers and expands the breadth of global compliance solutions to include both China and South Korea.

The platform enhancements further build on industry-leading serialization and traceability capabilities and provide numerous benefits, enabling customers to take advantage of dramatic scale, security and functionality improvements.

Agile Architecture to Meet Any Serialization Demand:

The release includes improved architecture and scalability so each software instance can now seamlessly create, manage allocate and store hundreds of millions of individual and aggregated serial numbers.  The latest regulatory requirements now require robust serialization processing, and the rfxcel platform has been thoroughly vetted to address the latest industry requirements.  Highly configurable serial number generation functionality has been bolstered to meet varying global and customer-specific serialization requirements, and serial numbers can also now be generated and allocated in larger ranges to enhance and improve serial number randomization.

The latest update also enhances and improves the logic behind existing bar code scanning functionality.  Data received from a bar code scanner can now automatically be directed to multiple fields, eliminating any potential data entry errors.   And by using smart logic, only relevant information from bar codes is parsed, such as GTIN, expiration, lot numbers and of course, serial numbers.

Expansive Global Compliance Offering:

The latest platform enhancements provide comprehensive compliance with all South Korea and China regulations and reporting requirements, including events reporting, serial number lookup and central reporting in the required format to China’s central agency.  The release also provides a flexible framework to meet upcoming global compliance requirements, such as the EU and Saudi Arabia. And while Brazil has postponed its deadline, the release includes all functionality to meet Brazilian compliance requirements in the event customers want to begin testing.  As with all country compliance modules, each country solution is delivered in one comprehensive, integrated platform.

Overall Ease of Use:

The enhancements also give customers even more flexibility and help make the product easier to use.  The new and improved functionality includes:

• Easier integration for rework and Edge Systems using newly created API’s.
• On-demand PDF generation of incoming ASN’s.
• Easier to find and attach ASN’s to receipts.
• Automatically create new customers and facility locations (and/or update information for each) during file processing and automatically create and send corresponding customer portal or rfxchange login credentials for each new customer created.
• Easier to send and match EPCIS standard fields with organizations who do not necessarily conform 100% to EPCIS data standards.
• Enhanced login and password rules also provide additional peace of mind and security to ensure proper permission and privilege for each registered user is authorized.
• Expanded reporting includes batch summary, inventory summary and error handling reports (that contain quantities) for deeper insight.

With a focus on delivering an exceptional customer experience, rfxcel is also expanding its product development team to build out the next generation of platform functionality.

“We invested a significant amount of resources to make the latest improvements to the rfxcel Traceability System™ (rTS).  By improving the core architecture, system performance and the ability to scale, these platform improvements allow us to not only improve the existing user experience and handle the needs of current customers, but also allows the system to easily handle an exponential increase in serial number volume”, commented Atul Mohidekar, CTO and SVP of Operations at rfxcel.  “rTS is continually improving to deliver a platform that is more flexible, scalable, secure and reliable – exactly what life sciences companies are demanding.  These latest improvements simply reinforce our product leadership position and commitment to our customers.”

A Global Leader in Serialization, Traceability and Compliance

rfxcel remains committed to delivering on its primary mission of securing the supply chain, enabling compliance with government regulations, improving patient safety and offering control and peace of mind for customers.

• Secure the supply chain: rfxcel provides users the ability to track, trace and monitor pharmaceutical products throughout the supply chain, helping to curb and solve some of the pharmaceutical industry’s biggest issues such as theft, channel diversion, counterfeiting and safe handling.  rfxcel also provides unit-level and hierarchy serialization for enhanced visibility and control of product throughout the supply chain.
• Enable compliance with government regulations: rfxcel provides comprehensive U.S. Drug Supply Chain Security Act (DSCSA) and global compliance management solutions in one integrated platform to meet the most complex regulations and reporting requirements, giving users peace of mind and simplifying country-specific compliance needs.  rfXcel is compliant with all GS1 standards and supports global, country-specific and any other custom format such as data formats specific to Brazil and China.
• Improve patient safety: rfxcel provides users deep insight and allows monitoring of pharmaceutical products throughout the supply chain.  The rfXcel Traceability System™ (rTS) can create, manage, allocate and store large volumes of individual and hierarchical serial numbers to provide visibility and control and help detect counterfeit drugs more easily. rfxcel also supports a mobile app to instantly authenticate and verify product validity using lots and/or serial numbers.
• Control and Deliver Peace of Mind for Customers:  The rfxcel solution is built on private cloud technology, which allows each customer system and implementation to be fully validated.  Unlike other multi-tenant solutions running on public cloud technology, rfxcel private cloud technology is tailored to meet the unique specifications and requirements of each customer.  It also 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.

About rfxcel

rfxcel Corporation, headquartered in San Ramon, CA, is a pioneer in creating Product Serialization, Traceability and Compliance private cloud solutions for the Life Sciences industry. Leading manufacturers, distributors, packagers, dispensers and retailers leverage rfxcel solutions to meet global government regulations, track and trace product throughout supply chains, and enhance patient safety.

For more information, please visit www.rfxcel.com.

FDA Delays Enforcement of DSCSA Transaction Information until November 26, 2018

San Ramon, CA June 30, 2017 — FDA issued a draft guidance for industry, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. This guidance informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions.

What is a product identifier?

• A unique identity for individual prescription drug packages and cases, which will allow trading partners to easily trace drug packages as they move through the supply chain.
• Includes the product’s lot number, expiration date, national drug code (or NDC), and a serial number. The serial number is different for each package or case. This creates a unique identifier – human and machine readable – to enable product tracing throughout the supply chain and enable all trading partners to better detect illegitimate products within the supply chain.

The compliance policy outlined in the draft guidance applies solely to products without a product identifier that are introduced into commerce by a manufacturer between November 27, 2017 and November 26, 2018.

While manufacturers work to meet product identifier requirements, they must comply with other DSCSA requirements.

Under the newly issued draft guidance, FDA says it will consider packages and homogenous cases of drugs to be “in the pharmaceutical distribution supply chain” if they were packaged by the manufacturer before 27 November 2018.

FDA says that packages or homogenous cases of product that do not bear a product identifier should be accompanied by documentation that it was packaged before 27 November 2018. “Manufacturers retain packaging date information in the ordinary course of business and as a part of batch recordkeeping, and they should provide the packaging date to subsequent trading partners if they request it,” FDA writes.

The guidance goes on to detail the specific requirements that grandfathered products are exempted from for manufacturers, wholesale distributors, dispensers and repackagers to clarify each parties’ responsibilities in a transaction involving grandfathered products.

Additionally, the guidance clarifies that saleable returned packages and homogenous cases of product are exempt from certain product identifier requirements if they were in distribution prior to 27 November 2018.