Movilitas.Cloud Earns Gateway Certified™ Accreditation for VRS Solution


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Movilitas.Cloud: VRS Verify™ Accreditation

Lexington, MA, March 14, 2025 – Gateway Checker, the industry’s leading independent GS1 Conformance Testing Service, today announced Movilitas.Cloud, as part of Engineering Industries eXcellence, has become the first product verification solution provider to successfully attain both Level 1 and Level 2 Gateway Certified™ VRS Verify™ accreditation.

The FDA Drug Supply Chain Security Act (DSCSA) requires Pharmaceutical trade partners to have systems to facilitate saleable returns verification. In response to regulation, the Verification Router Service (VRS) was developed by the Healthcare Distribution Alliance (HDA), aiming to automate verification requests and achieve near real-time responses.

With VRS systems, authorized pharmaceutical trading partners can confirm that the unique set of product information (lot number, expiration date, trade identifier, and serial number) assigned to a drug matches the information recorded by the manufacturer.

Successful system-to-system interoperability requires extensive testing and validation, and the cooperation and resource commitment of competitive systems. Up until now, VRS testing results are typically self-executed and reported by the solution provider, a tedious and often inaccurate approach to testing and validation. Gateway Checker developed an independent, unbiased VRS conformance testing platform, VRS Verify™, that quickly, robustly and reliably executes VRS test scenarios.

Demonstrating a commitment to supply chain integrity and DSCSA compliance, Movilitas.Cloud has become the first DSCSA solution provider to be awarded Gateway Certified VRS Verify™ accreditation.

“Gateway Checker has always been heavily involved in the development of the VRS standards and builds tools to measure the health of this multivendor platform,” said Marc Blekkink, Founder and Managing Director of Movilitas.Cloud. “We are very pleased that an independent organization has begun certifying these solutions, allowing the market to select a trusted partner for DSCSA verification requirements.”


Next Steps

  • For more information on VRS Verify™ and to receive a free product verification assessment, please complete the form at this link.
  • To check out Gateway Checker’s other suite of services designed for DSCSA Compliance, click this link.
  • To read the full press release from Movilitas.Cloud, click this link.
  • Media Contact: Gary Lerner – glerner@nullgatewaychecker.com

About Gateway Checker:

Gateway Checker™ is a Software as a Service platform that facilitates product traceability, DSCSA compliance, and unambiguously verifies the interoperability readiness of serialized pharmaceutical transaction records. Drug manufacturers, repackagers, and distributors can quickly and continuously test, validate, and certify adherence to GS1 US Rx EPCIS and VRS product verification application standards. Gateway Checker is certified by the GS1 US RX EPCIS Testing Service Certification Program and is owned and operated by the Gateway Checker Corporation, a wholly-owned subsidiary of BrandSure, LLC.

Why You Need VRS Validation

female-pharmacist-with-table-checking-stock-pharmacy

Photo Credit: Freepik

The Importance of Validating Product-Verification Systems

As discussed recently, VRS Systems are the most effective way to verify product in accordance with DSCSA regulations. Additionally, the widespread use of VRS Systems provides invaluable information to trade partners, including product-specific information such as supply status by trade partner, volume of activity, and location.

Furthermore, immediate product verification provided by VRS systems proactively prevents non-suitable product from entering the supply chain, preventing timely and expensive recalls. The product-verification and commerce-related benefits of VRS Systems exemplify their value to any trade partner within the pharmaceutical supply chain.

The only way trading partners can benefit from VRS systems is if these systems function properly, and produce accurate and timely responses to verification requests. However, ensuring functionality is easier said than done.

A successful VRS network requires a common Product Identifier (PID) lookup directory, as well as a precise alignment of request/authentication/response functionality between multiple solution providers. Solution providers typically rely on self-testing to establish system readiness, and given the abundance of competing solution providers, VRS System validation is not straightfoward.

Additionally, since product verification requests originate external to a solution provider’s environment, pharmaceutical manufacturers can’t validate system readiness independently; manufacturers must rely on external testing to ensure their systems are working properly and are prepared to support specific use cases.

The Accreditation of VRS Systems with VRS Verify™

In recognizing the importance of properly functioning VRS Systems, particularly as more authorized trading partners and solution providers began adopting them, Gateway Checker developed the VRS Verify™ accreditation program.

The first of its kind, VRS Verify™ offers comprehensive, objective testing, documented evidence, and conformance certification for manufacturers and solution providers to ensure alignment with product verification application standards. These standards include the GS1 Lightweight Messaging Standard for DSCSA Verification of Product Identifiers, as well as the Healthcare Distribution Alliance (HDA) VRS Working Group Verification Router Service System Readiness Testing protocols.

VRS Systems who meet the protocols set forth by VRS Verify™ assure owners and operators of proper VRS functionality, providing both themselves and their trading partners the confidence that product verification needs will be met as necessary.

VRS Verify™:

  • Ensures the VRS system produces accurate and timely responses to verification requests.
  • Automatically generates and executes VRS validation test scripts.
  • Generates documentary evidence of tests executed and the results.
  • Assesses readiness of the VRS system to meet user and industry requirements.

To learn more about VRS Verify™, and for a complimentary product verification assessment, visit this link.

Who Needs Product Verification, and Why It’s Important for the DSCSA and Beyond

pharmacist-white-uniform-walking-by-shelf-with-medicines-checking-inventory

Photo Credit: Freepik

How VRS Benefits the Entire Pharmaceutical Supply Chain

Last Friday, I described the importance of Verification Router Service (VRS) systems, introducing the benefits they provide within the pharmaceutical supply chain. As emphasized previously, the value of VRS systems extends beyond saleable returns, helping streamline product verification for trading partners and ensure product legitimacy. In this article, I dig deeper into the importance of product verification, and specifically, how VRS systems enhance supply integrity beyond saleable returns.

Manufacturers:

As the starting point of the supply chain, manufacturers are responsible for establishing accurate drug transaction records for each ownership change; they must inform trade partners when product is substandard, illegitimate, or for some reason is no longer fit for consumption. According to the DSCSA, manufacturers are required to respond to requests for product verification within 24 hours for any authorized trade partner, regardless of any direct relationship with that trade partner.

VRS systems allow manufacturers to confirm product identifier information (lot number, expiration date, trade identifier, and serial number) to other trade partners across the supply chain, within seconds. Absent a VRS, manufacturers must provide another method that executes the same product verification response (e.g. utilizing email or the telephone); alternatives are not only less effective, but also, more expensive.

Manufacturers who use VRS systems gain insight into all product verification requests, which include requester identification, email, phone number, and location. With widespread utilization of VRS for status checks, incoming inspection, and outbound checking, manufacturers gain additional product-specific supply status by trade partner, volume of activity, and location. VRS also enables early warning of nefarious activity, including product diversion and counterfeit activity.

Distributors:

Under the DSCSA, wholesale distributors are required to verify the authenticity of returned products before these goods re-enter the supply chain. If there is evidence that a returned product has been properly handled and is not expired or damaged, and its product identifier is verified, then that product can be resold. VRS systems provide immediate product verification, minimizing determination delays and helping prevent quarantines that may impede medication delivery.

Expanded use of VRS, beyond saleable returns, can facilitate confidence in authenticity and suitability for further distribution.  From inception, VRS is enabled to indicate if a specific product is suspect, illegitimate, or recalled. Integrating product verification requests into a distributor’s workflow can make the process more efficient and seamless, while yielding proactive awareness of pharmaceuticals not suitable for further distribution.

Widespread VRS use by distributors enhances the aforementioned benefits to manufacturers.  However, distributors are likely to consider expanding use of VRS only after increased participation by manufacturers.  So chickens and eggs need to worry less about which comes first, and commit to greater utilization for the benefit of the US pharmaceutical industry.

Dispensers:

For dispensers, product verification through VRS systems allows for authentication of products both received from distributors, and product brought to their attention by patients. In a recent investigation of suspect product, the Arkansas Board of Pharmacy demonstrated the value of VRS systems by successfully detecting counterfeit Ozempic.

The efficacy of these systems in preventing suspect and substandard product from reaching patients results in greater consumer trust in the supply integrity of pharmaceuticals, and possibly individual pharmacies as well.

Conclusion

VRS Systems are vendor-independent—regardless of a trade partner’s role in the pharmaceutical supply chain, there’s substantial benefits to implementing these systems. Instantaneous product verification minimizes supply chain disruptions and helps prevent substandard medicines from reaching (and potentially harming) patients.

With the DSCSA deadline approaching quickly, the importance of product verification has increased substantially. VRS Systems are the most effective way to verify pharmaceuticals in accordance with DSCSA regulations. Additionally, widespread use of VRS systems can provide reliable, actionable intelligence while improving drug supply security.

If interested in increasing the use of VRS, it is a challenge to test suitability and readiness to support specific use cases. Gateway Checker’s VRS Verify™ executes drug verification requests external to the product verification responders system, enabling the ability to emulate real-world conditions and validate the functionality of the response, including access to the lookup directory.

VRS Verify™:

  • Ensures the VRS system produces accurate and timely responses to verification requests.
  • Automatically generates and executes VRS validation test scripts.
  • Generates documentary evidence of tests executed and the results.
  • Assesses readiness of the VRS system to meet user and industry requirements.

Solution providers and manufacturers that successfully execute VRS Verify™ test scripts can become Gateway Certified, the industry’s seal-of-approval that a VRS system functions as necessary and adheres to strict industry requirements.

To learn more about VRS Verify™, and for a complimentary product verification assessment, visit this link.


Coming Up Next: “Ensuring VRS System Functionality: Why VRS Validation is Essential”

 

Beyond Saleable Returns: The Benefit of VRS Systems

pharmacist scanning a pharmaceutical product

Photo Credit: DC Studio on Freepik

What is a VRS System, and What Value Does it Provide?

Under the Drug Supply Chain Security Act (DSCSA), US pharmaceutical trading partners are required to verify the Product Identifier (PID) of a pharmaceutical product when items are suspect or considered for saleable returns. To deploy a widely available (and highly responsive) product verification system into a disparate and decentralized ecosystem, the solution providers in the United States forged a Verification Router Service (VRS) network, an atypical cooperative and collaborative alliance among competitors.

VRS systems simplify and streamline the product authentication process, allowing trading partners, whether purchasing the goods directly or indirectly, to check and verify product-specific information with ease. Product verification requires an exact match of trade item identifier, packaging lot, product expiration date, and item-specific serial number. The product manufacturer executes the verification response, confirming the unique information assigned to a specific product carton or homogenous container.

The VRS system makes it quick and easy to confirm product legitimacy for authorized trade partners at any point in the supply chain. Additionally, when product expires or adverse events such as stolen, illegitimate or recalled product occurs, VRS can instantly notify the requestor and stop product from being further distributed.

While VRS systems are often recognized for their ability to verify saleable returns, VRS systems support a variety of additional functions that help keep supply chains safe:

Authentication of trade partners amidst product shortages, allowing more flexibility in finding safe supplies of drugs in times of need.

The immediate confirmation of the type, location, and quantity of product, regardless of who possesses the product at the time of inquiry.

The easy and prompt identification of potential counterfeits in the supply chain, as demonstrated by the Arkansas Board of Pharmacy with Ozempic.

A successful VRS network requires a common PID lookup directory, and the collaboration of many different solution providers who typically rely on self-testing and self-reporting to comply with product verification requirements. Regardless, the added benefits clearly demonstrate that VRS systems make this cooperative effort worthwhile.

Given the complexities of pharmaceutical supply chains today and the risks of counterfeiting, traditional means of verification simply aren’t enough. While industry has stressed traceability, VRS systems provide an extra layer of security by allowing trade partners to instantly verify pharmaceutical authenticity.

Gateway Checker: VRS Verify™

Just as important as having a VRS System enabled is ensuring the system is appropriately configured and performing to both application standards and industry expectations. The Gateway Checker VRS Verify™ testing module independently tests systems, validating responses externally to a drug supplier’s system environment. With VRS Verify™, you and your trading partners can be confident that your system functions as intended and meets strict industry requirements.

VRS Verify™:

●      Ensures the VRS system produces accurate and timely responses to verification requests

●      Automatically generates and executes VRS validation test queries

●      Confirms the VRS system meets user and industry requirements

●      Generates documentary evidence of successful testing

Successful VRS tests are eligible to become Gateway Certified™, the only independent product VRS testing service available. Gateway Checker™ is the US Pharmaceuticals industry leading GS1 Certified Conformance Testing Service.

To learn more about VRS Verify™, and for a complimentary product verification assessment, visit this page.


Coming Up Next: “Who Needs Drug Product Verification and Why?”

 

How to Best Prepare for Final DSCSA Deadlines

DSCSA Deadline: Coming Soon

As highlighted numerous times since its announcement, the FDA has provided an exemption for certain eligible trading partners from Enhanced Drug Distribution Security (EDDS) Requirements of the Drug Supply Chain Security Act (DSCSA). These exemptions vary in length depending on the trade partner; for manufacturers and repackagers, the deadline for compliance is May 27th, 2025… less than four short months away. For other types of eligible trading partners, the deadlines come shortly after.

Tracy Nasarenko, Vice President of Consumer Success (Healthcare) at GS1 US, recently published an article emphasizing the importance of data quality for adherence to DSCSA guidelines. If a trading partner has missing/incorrect information in their master data (i.e. GLNs or GTINs), exceptions and possible quarantines could be the result; situations like this may prevent patients from receiving necessary medications.

Recall that potential supply chain delays were the main reason the FDA implemented the stabilization period (as well as the recent October 10th exemption) in the first place. The FDA was concerned that with not enough trading partners prepared to send and receive interoperable data, extensive product and data delays could inhibit millions of patients from receiving medications in a timely manner.

However, following numerous delays and exemptions, its more than likely the May 27th deadline for manufacturers and repackagers will remain in stone. Additionally, given how much time has been allotted for trade partners to prepare their systems and meet DSCSA requirements, not as much leeway will be given by the FDA for those who aren’t ready.

How to Prepare for the DSCSA

While adhering to the requirements of the DSCSA may seem a bit overwhelming, here’s a few tips that will help simplify the process:

  1. Understand the law and exemptions: review materials pertaining to the DSCSA, including FDA guidances and the DSCSA itself, to ensure you and your trading partners understand what the law actually mandates. Understanding the details of the recent exemption (who it applies to, and until when) is also essential.
  2. Ensure interoperability of systems: make sure your systems are prepared to seamlessly exchange information with your trading partners. Interruptions in the digital exchange of information will interrupt the physical flow of product.
  3. Get tested: test data exchanges with your trading partners to address potential connectivity complications. Gateway Checker offers the only independent, GS1 Certified Conformance Testing Service, allowing trade partners to proactively identify and remediate conformance and interoperability issues.
  4. Communication: the HDA previously released a “DSCSA Lessons Learned’ Webinar, and a highlight of the conversation was the importance of communication. Given the complexity of the supply chain, different trading partners have different ways of ensuring compliance. Communicating these processes with your trading partners is key.
  5. Don’t Wait: compliance has moved from a future consideration to a present-day necessity. Wherever your progress is in reaching full DSCSA conformance, learn how Gateway Checker can help by visiting our website.