Vantage Consulting Group Paves way for Drug Manufacturers to implement and demonstrate GS1 EPCIS 1.2 compliance for FDA’s DSCSA Track and Trace Requirements
QU4RTET 3.0 is first Level 4 Serialization Solution to Earn Drummond Certification per GS1 EPCIS 1.2 Conformance Program
Portsmouth, NH — March 9, 2020 —Drummond Group, the trusted leader in software compliance and interoperability testing, announced Vantage Consulting Group selected Drummond for the validation and certification of the Level-4 open source solution QU4RTET 3.0 in accordance to GS1 US Rx EPCIS Conformance Testing Program.
Drummond is pleased to announce that QU4RTET 3.0 has earned Drummond’s EPCIS 1.2 Certification seal. Vantage for implementation of QU4RTET so that these manufacturers can then earn their GS1 EPCIS 1.2 Trustmark’s for the Manufacturer Test Scenarios.
With GS1 US overseeing the program, Drummond validated QU4RTET’s compliance to all seven manufacturer role-based test scenarios as defined by GS1 EPCIS 1.2 Implementation Guidelines.
Vantage is taking a leadership role in ensuring EPCIS 1.2 messages between the manufacturer and the wholesaler are following the proper format and structure to support DSCSA track and trace requirements. Vantage recognizes the following advantages in bringing QU4RTET into compliance, the first L4 Software Solution to be validated and certified by Drummond for EPCIS 1.2.
- It is essential to demonstrate compliance to the FDA’s Drug Supply Chain Security Act (DSCSA) for traceability in the supply chain
- Earning the Drummond EPCIS 1.2 Certification seal is the first step in demonstrating compliance to DSCSA interoperability requirements for serialization. It is very important to us as a QU4RTET integration provider
to ensure our customers can implement a GS1 EPCIS 1.2 certified solution so that they can earn their GS1 Trustmark for their implementation of QU4RTET 3.0
“Drummond’s rigorous yet intuitive EPCIS Conformance Portal, a web-based compliance testing service, was key to providing us with a straightforward way to demonstrate QU4RTET compliance to GS1 EPCIS 1.2 Implementation Guidelines. This provides assurance to our customers that Vantage is committed to guiding pharmaceutical manufacturers toward meeting DSCSA track and trace requirements” said George Poltorak, Vantage Consulting Group CEO.
“Drummond was the first testing service to be certified by GS1 and we are pleased to announce QU4RTET 3.0 has been conformance validated against GS1 EPCIS 1.2 Implementation Guidelines, which define how GS1 standards can be used to meet DSCSA track and trace requirements in an interoperable way” said Aaron Gomez, Drummond, Principal, Supply Chain Security business unit.
Further, Drummond is committed to the GS1 EPCIS Conformance Program and we welcome any stakeholder in the pharmaceutical supply chain impacted by FDA’s DSCSA mandate to contact Drummond to learn more about this testing service and for inquires to discuss how to gain trial access and a request demonstration.
Drummond offers a comprehensive suite of services (including GS1 GDSN Data Pool Certification Testing), to help you achieve compliance with regulatory information security mandates and ensure critical business applications meet interoperability and application conformance. Increase trust, gain expertise and experience our proven methodologies and attention to detail as we partner with you for your long-term success. For more information visit: www.drummondgroup.com
About Vantage Consulting Group
Vantage is the manufacturing productivity company. For manufacturers facing safety, quality, or efficiency challenges, we provide strategic guidance and cost-effective execution of initiatives to improve serialization, packaging, inspection and more. Our team is seasoned, lean, on time and within your budget. www.vantage-cg.com.
QU4RTET is a collaborative track and trace software and an open-source platform. The code is perpetually open source once released and, thus, public domain.
QU4RTET proudly boasts historic support by capital investors and is bolstered by developer time and resources. The open-source code has been collectively created by experienced developers with decades of industry knowledge. QU4RTET supports EPCIS 1.2.