Farmington Hills, Michigan, April 30, 2019 – LSPediA Inc., a leading software and service provider for the pharmaceutical industry, today announced the addition of notification for recalled and suspect product investigation to its Investigator® solution, a Verification Router Service module.
“One out of every three drug product packages is likely to fail the barcode verification due to coding or scanning issues. In addition, recalled drugs or suspect products are creeping up in volume in the supply chain. Failing to identify these drugs and document their handling can be a serious liability for a wholesale distributor and the respective manufacturer,” said LSPediA CEO Riya Cao. “The primary responsibility of the FDA is to enforce the law of patient safety by removing the dangerous drugs out the supply chain.”
Drug products that can’t be verified can’t be resold. They require additional investigation to confirm their true authenticity. The added functionality of Investigator® manages the inbound and outbound notifications for negative verifications. The corresponding manufacturer receives an electronic alert when their product fails the VRS verification. Investigator® then facilitate a collaborative environment for suspect products handing and 3911 reporting as required under the Drug Supply Chain Security Act. All events are captured with a complete history for six years and are easily accessible for audits.
The verification requirements of the DSCSA for wholesale distributors requires that they verify all potentially saleable returned drugs, but that they also notify the FDA and trading partners when they find suspect or illegitimate products. Without a rock-solid workflow built into the verification process, wholesale distributors face the prospect of being forced to manually check and confirm their share of those 12 million units, a process that is sure to be expensive, time-consuming and confusing – all while being exposed to liability if anything is mishandled.
LSPediA’s Investigator® is a stand-alone and turnkey exception management solution that can be deployed as a “bolt-on” to other VRS platforms. It has emerged as the preferred platform for regulatory compliance in the areas of suspect product investigation and illegitimate product handling. It’s automated workflow and complete audit tails offer direct communications between trading partners with in-app camera enabling supply chain collaboration and interchangeability.
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About LSPediA – Life Sciences Solutions
LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solution RxChain enables pharmaceutical manufacturers, wholesale distributors, dispensers to manage data, distribute products, and track inventory at the serialized level. LSPediA’s Verification Router Service enables authorized trading partners to authenticate serialized products, verify returns, and deter counterfeiting.