rfxcel launches fully integrated Warehouse Edge System with partner Navitas Life Sciences

rfxcel Corporation, the global serialization and track and trace provider for the Life Sciences industry, announced today that its industry-leading traceability system now has fully integrated “edge” functionality for warehouse, distribution and re-work operations (Warehouse Edge System).

rfxcel has extended its successful partnership with Navitas Life Sciences (“Navitas”) to provide a seamless and efficient solution to enable customers to meet obligations under the European Falsified Medicines Directive (EU FMD), US Drug Supply Chain Security Act (DSCSA) and other serialization requirements. The advanced and simple-to-use features of the Navitas traceREADY edge system are now completely integrated with rfxcel’s Traceability System (rTS).

“The new capability provides a truly full-service, one-stop capability for distributors, manufacturers, and the many companies who have a complex hybrid of both operations. Edge and re-work activities during manufacturing and supply can now be handled directly and smoothly in our system. As global regulations increasingly affect distribution as well as manufacture of medicines, we are positioned to offer what customers need” said Glenn Abood, CEO of rfxcel.

“We are pleased to strengthen our successful relationship with rfxcel. Our fully integrated solution now provides customers with significant cost and performance efficiencies. We look forward to taking our solution to the global market and deliver enhanced value to our customers” said Ram Yeleswarapu, President, Navitas Life Sciences.

In the complex world of traceability, rfxcel is refreshingly easy to work with. Transparent pricing and robust private cloud architecture allows customers to get compliant quickly and at predictable cost. They can then focus on their core business without the constant risk assessment and revalidation required by some providers.

Learn more about Serialisation/Serialization and their edge system by booking a 30 min demo with the IT team.

DSCSA for Wholesale Distributors

DSCSA for Wholesale Distributors: 

Wednesday, April 18, 2018

PDT: 10 a.m. | EDT: 1 p.m.

Register here

 

Please join rfxcel for a webinar that will provide insight into Phase II of the DSCSA Regulation for Wholesale Distributors. During this 1 hour long presentation, we will discuss:

1. FDA/DSCSA Activities for Wholesale Distributors 

2. Main points to note: FDA Grandfathered Draft Guidance 

3. A Timeline for DSCSA requirements 

4. The Role of the Solution Provider 

5. Top Concerns from Wholesale Distributors 

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. The platform enables companies to protect patients, comply with regulatory mandates, and gain visibility into their supply chain. rfxcel’s relentless commitment to customer success and continuous innovation ensures that companies can meet today’s requirements and tomorrow’s challenges.

 

DSCSA for Wholesale Distributors rfxcel

EMVO Onboarding & EU Falsified Medicines Directive

EMVO Onboarding & EU Falsified Medicines Directive: 

What to Know and Where to Begin

Presented by:

Fanny Trenteseaux Project Coordinator/Customer Relation Manager

European Medicines Verification Organisation  &

Mark Davison Senior Operations Director for rfxcel

Thursday, March 29, 2018

16.00 BST / 17.00 CEST / 11:00 AM EDT

 

Register here

 

Please join us for a webinar explaining the EMVO Onboarding Process and the Falsified Medicines Directive requirements; co-presented by Fanny Trenteseaux of the European Medicines Verification Organisation (EMVO) and Mark Davison of rfxcel. On this hour-long call, we will provide:

  1. A brief introduction to the EU Falsified Medicines Directive/Delegated Regulation
  2. Explanation of the EMVO and how to onboard your organization
  3. How to choose a gateway provider (IT partner)
  4. Q&A – plenty of time to get your specific queries answered

 

About Our Speakers:

Fanny Trenteseaux, a member of EMVO’s Commercial & Partner Management team, is a Project Coordinator and Customer Relation, Manager. She is actively assisting with the contractual on-boarding process, manages the Legitimacy Check process, and manages the Community of National Medicines Verification Organisations.

Mark Davison, Senior Operations Director for Europe at rfxcel, is a leading traceability and digital health expert as well as the published author of “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”. Mark specializes in global health and big data issues such as serialisation, supply chain security, patient safety and government policy.

 

EMVO Onboarding rfxcel
EMVO Onboarding rfxcel

FAQ from Wholesale Distributors

These questions were asked at our Certification Course in collaboration with Life Science Training Institute:
LSTI Course: Key Elements of Pharmaceutical Serialization and Implementation 

 

FAQ from Wholesale Distributors:

Listed are all pending compliance requirements, including the Salable Returns.

 

  1. How does DSCSA apply for distributors?
Nov. 27, 2019 Accept only serialized product Wholesalers may engage only in transactions of products encoded with unique product identifiers, which will be used to verify a drug’s legitimacy and enable product tracing in the event of a recall or the identification of a suspect product.
Nov. 27, 2019 Match original transaction information with returned products that will be resold. Wholesalers may accept returned products for resale only if they can associate the returned product with the original transaction information and transaction statement for that product.
Nov. 27, 2019 Verify unique product identifier of suspect products at package level. Wholesalers must verify the product identifier, which includes the standardized numerical identifier, or SNI, for products they suspect are potentially counterfeit, diverted, or otherwise unsafe.
Nov. 27, 2019 Verify the unique product identifier of returned products intended for resale. Wholesalers must verify the product identifier, including SNI, of returned products intended for resale.
Nov. 27, 2023 Participate in electronic package-level traceability system Wholesalers must exchange transaction information and statements in an interoperable electronic manner, and the transaction information must include product identifiers. Wholesalers must put in place systems and processes for electronic package-level verification and provide traceability information to regulators to permit access to a drug’s full distribution history when investigating a suspect.

product or during a recall.

 

 

  1. Explain grandfathered products: Can they be sold? What do they mean?RELATIONSHIP TO “GRANDFATHERED” PRODUCTS UNDER SECTION 291 582(a)(5) OF THE FD&C ACTThis compliance policy addresses products a manufacturer introduces in a transaction into commerce without product identifiers between November 27, 2017, and November 26, 2018. In the future, FDA intends to issue additional guidance that will outline FDA’s current thinking on the “grandfathering product” provision of section 582(a)(5)(A) of the FD&C Act regarding products not labeled with a product identifier that are in the pharmaceutical distribution supply 298 chain at the time of the effective date of the requirements of section 582. In that guidance, FDA intends to address the relationship of the compliance policy set forth in this guidance with “grandfathered” products.DSCSA non-enforcement draft guidance

The full compliance policy still hasn’t been published, as it’s going through review as a draft to accept challenges, recommendations and a critique (the comment period closed in January). The primary reason for seeking further guidance dealt with enforcement of DSCSA, specifically with regards to manufacturers applying serialization to products. The deadline for compliance here remains Nov. 27 of 2017, but in the draft the FDA states they will not enforce the manufacturers’ product identifier requirements under the DSCSA for another full year. While this buys some manufacturers, wholesalers, and repackagers some more time, it begged the question about what “introduced in a transaction into commerce before Nov. 26, 2018” meant.

Specifically, from lines 37-41 of the draft guidance:

‘In brief, FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogeneous case of products intended to be introduced in a transaction into commerce before Nov. 26, 2018. This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers.’

What does that mean? A less conservative approach might assume that as long as the batch is released before Nov. 27, 2018, then there is no requirement for compliance, even if shipping that product after the deadline. The more conservative approach would have meant to consider each and every product individually. Fortunately, the November 2017 Grandfathering draft guidance clears this up.

The Grandfathering draft guidance specifically states (from lines 122-124):

‘For the purposes of this guidance, a package or homogenous case of product is “in the pharmaceutical distribution supply chain” if it was packaged by the product’s manufacturer before November 27, 2018.’

The key word is “packaged”. Any product “packaged by the product’s manufacturer” before the deferred compliance enforcement date (November 27, 2018) will be exempt from enforcement of DSCSA requirements for affixing a Product Identifier. Subsequently, this draft guidance exempts any trading partner requirements relating to Product Identifier as it relates to product supplied by a manufacturer if that product was packaged by the manufacturer before November 27, 2018 without affixing a Product Identifier to that package or homogenous case. This includes the following:

 

Exemptions for Product Packaged by a Manufacturer without a Product Identifier before 11/27/18:

  • The investigation of suspect product, that is verifying product at the product level using the Product Identifier (this applies to manufacturers, as well as their downstream trading partners).
  • Wholesaler requirements that they engage in transactions involving only product encoded with a Product Identifier beginning November 27, 2019.
  • Dispenser requirements that they engage in transactions involving only product encoded with a Product Identifier beginning November 27, 2020.
  • Repackager requirements that they accept ownership of product encoded with a Product Identifier beginning November 27, 2018.

However, it is important to understand what is not exempted.

 

Not Exempted (for any manufacturer or downstream trading partner):

  • There is no extension of compliance dates for the requirements for investigation/verification of product at the package level using the Product Identifier Product packaged by a manufacturer (or repackager) prior to November 27, 2018 that has had a Product Identifier affixed to its labeling.
  • There is no exemption from the requirement to validate any applicable transaction history and transaction information in their possession and otherwise investigate any suspect product to determine if it is illegitimate.

 

And specifically, for repackagers:

  • If a repackager wishes to transfer ownership of a package or homogenous case of product without a product identifier on or after November 27, 2018, it must first add a product identifier to the package or homogenous case of product. Basically this is saying that all product packaged after November 27, 2018 must be serialized (have a Product Identifier), regardless if it is packaged by a manufacturer or a repackager.
  1. What are the penalties if you don’t follow DSCSA?

As of this moment FDA didn’t announce any penalties.

  1. What products don’t need to comply with DSCSA? 
  • Blood or blood components intended for transfusion
  • Radioactive drugs or biologics
  • Imaging drugs
  • Certain IV products
  • Medical gas
  • Homeopathic drugs
  • Lawfully compounded drugs

 

We appreciate your feedback and would like to know how else we can help. Please send your questions or comments about “FAQ from Wholesale Distributors” here.

 

About Life Science Training Institute (LSTI)

rfxcel Solution Recognized in HDA Distribution Management Award

March 6, 2018 – San Ramon, CA – rfxcel, the world’s leader in supply chain track and trace for the Pharmaceutical industry is one of two companies recognized by the HDA (Healthcare Distribution Alliance) for “…:efforts to improve the efficiency, effectiveness and safety of the healthcare supply chain through successful trading partner initiatives.”

“The award highlights innovative collaborations between distributors and manufacturers that enhance processes, reduce costs and leverage advanced technologies or logistical practices. Recipients are models for leadership and innovation in the pharmaceutical distribution industry and demonstrate the power of successful trading partner relationships .“ HDA Distribution Management Award

rfxcel’s Environmental Monitoring (EM) solution, was awarded Merit Finalist by the HDA for our work to enable real-time visibility of the Pharmaceutical supply chain via IOT (Internet of Things) technology.  The EM solution was piloted with a global manufacturer to track high-value pharmaceutical shipments – delivering real-time location and temperature data across 24 domestic and international locations.

“We at rfxcel are extremely excited about this award from the HDA.  It is recognition not only of our innovation but our commitment to partnering with the HDA and other industry leaders.” said, Glenn Abood, CEO of rfxcel.  

During the pilot, the rfxcel EM solution identified temperature excursions in real-time and alerted the manufacturer to these risks.  This allowed the manufacturer to take immediate action with their logistics provider and protect the integrity of their products. The solution also identified shipments which were improperly delivered to holding locations that were not approved to handle the products.  These improper deliveries were corrected in real-time avoiding potential damage to the high-value products.

“Today, many pharmaceutical companies are focused on meeting near-term serialization and compliance requirements such as Europe’s FMD (Falsified Medicines Directive), United State’s DSCSA (Drug Supply Chain Security Act), and many other governmental requirements. Our EM solution allows companies to extend the value of their compliance and serialization investment to gain new business value that was previously unavailable. Many companies talk about ‘Value Beyond Compliance’ but today, we have demonstrated that we can deliver on this commitment.” said Jack Tarkoff, Chief Strategy Officer of rfxcel.

As the pioneer and leader in traceability solutions for the Life Sciences industry, rfxcel provides its customers with a robust and sophisticated platform with a low total-cost-of-ownership. The EMVO certification – combined with a recent $30M growth capital infusion, the acquisition of Frequentz assets, and important key hires in Europe – widens the Company’s lead as the most versatile player in the industry.

To learn more about the HDA Distribution Management Award, visit:https://www.hda.org/about/industry-recognition/dma

If you would like to receive more details or see a demo of rfxcel’s Environmental Monitoring (EM) solution, please contact us at: https://www.rfxcel.com/contact-rfxcel/

 

For more information contact us:

Herb Wong, VP Marketing

hwong@rfxcel.com

rfxcel.com

 

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. Their platform enables companies to protect patients, comply with regulatory mandates, and gain visibility into their supply chain. rfxcel’s relentless commitment to customer success and continuous innovation ensures that companies can meet today’s requirements and tomorrow’s challenges.

To learn more here: Serialization Software

HDA.Award.rfxcel.traceability