Lspedia 及其合作者开展 DSCSA 例外试点
LspEdia启动了一项试点计划，旨在为供应链中的DSCA异常管理开发改进的解决方案和流程，来自处方药供应链的参与者和观察员也加入了该计划。该程序旨在针对复杂的数据错误得出与系统无关、可操作的调查结果，这些错误可能会在产品易手时中断流动。
例外情况是由于数据不正确、数据缺失、产品缺失或货件差异而无法接受已配送的产品时发生的数据错误。这样的错误在DSCSA的实施中已经是不可避免的，因为EPCIS数据交换对许多贸易伙伴来说是新事物。这些错误会阻止产品移动，增加复杂性，增加员工工作量，增加劳动力和成本。它们造成的延误可能使药物无法送达患者。
Since November 2023, data needs to accompany regulated pharmaceutical products every time it changes hands. This led to an explosion in EPCIS file exchanges and exceptions increased right along with them. To prevent these disruptions, LSPedia collaborated across the industry, launched and led this pilot program designed to foster deep understanding of new problem scenarios before they occur widely, in order to define the solutions, procedures, and best practices to keep prescription drugs moving through the supply chain.
该试点项目为整个供应链提供了不可知的例外解决方案，并为不同的业务类型提供了有针对性的流程和程序。它涵盖了与EPCIS数据、数据交换和物流有关的一系列问题，并纳入了HDA的 “DSCSA例外指南” 中的例外类别。其中包括没有数据的商品、没有商品的数据、包装或标签问题以及其他差异。Exceptions Guidelines for the DSCSA.” Which included product without data, data without product, packaging or labeling problems, and other discrepancies.
The group compiled a comprehensive list of error scenarios and design methods to resolve them. Metrics were developed to evaluate each method, reach consensus on how they should be applied, and recommend best practices.
合格的参与者是制造商、批发分销商、配药商和医疗保健提供商，包括LSPedia客户和非客户。Pilot成员将每月开会两次，讨论当前结果，确定新的例外情况，为已发现的问题提出解决方案，交流与异常管理相关的想法和实际业务需求。该小组将于美国东部时间星期三下午2点开会。该计划预计将于2023年5月结束。 DSCSA exceptions management pilot was a crucial step in ensuring compliance with the regulations by bringing together industry leaders, real EPCIS data, and effective resolutions. By testing and refining solutions with actual data and input from industry leaders, pilot participants collaborated to develop a comprehensive and effective solution that helps companies maintain DSCSA compliance and improve the efficiency of their supply chain operations.
我们的 DSCSA 异常管理试点是确保遵守法规的关键步骤，因为它汇集了行业领导者、真实的 EPCIS 数据和有效的解决方案。通过使用行业领导者的实际数据和反馈来测试和完善我们的解决方案，我们能够开发出全面有效的解决方案，帮助公司保持DSCSA合规性并提高其供应链运营的效率。Investigator is a module of its OneScan Suite that can cut the resolution time for an exception from days to minutes by automatically alerting users to EPCIS errors and guiding them through the resolution process enabling them to locate a problem before it can stop business. Its notifications include live hyperlinks allowing the point of contact to quickly view the issue and apply necessary fixes.
Investigator is now the industry's leading go-to exceptions management solution for the FDA’s Enhanced Supply Chain Security 2023 requirement, a mandate under the Drug Supply Chain Security Act (DSCSA). It manages the errors and failures that arise from new DSCSA transactions including EPCIS and VRS.
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