Special Project NFSDX Integration or ORAPP Adoption Analytical Track

提高能力和容量 微生物和化学检测支持 食品防务与食品安全一体化体系 特殊项目规程、NFSDX和ORAPP集成分析跟踪 项目摘要/摘要 俄亥俄农业部(ODA)消费者保护实验室(CPL)提议 加强其实验室信息管理系统(LIMS)，以允许直接转移 实验室结果提交给FDA国家食品安全数据交换(NFSDX)。这一增强功能 将允许立即访问实验室信息并将其链接到有效的FDA 通过监管事务办公室合作伙伴门户网站(ORAPP)进行调查。要完成 为此，oda-cpl的实验室和IT团队将与FDA NFSDX和ORAPP团队合作 以及他们的LIMS的开发供应商AcClaim，以确定报告字段中的差距或 需要调整的格式，提出最终的工作范围，授权所述工作并将 在项目年度结束前将成品投入生产。在此过程中，官方发展援助-- CPL将在会议上与NFSDX和ORAPP团队协作进行故障排除， 在项目实施阶段指导和确定紧急问题。 实验室将签署谅解备忘录和互联互通安全 根据项目参与的要求与FDA达成协议。最后，实验室将 参与数据交换入职会议，并完成与以下项目相关的FDA任务 NFSDX和ORAPP。

Increasing the Capability and Capacity of Microbiological and Chemical Testing to Support an Integrated Food Defense and Food Safety System Special Projects Discipline, NFSDX and ORAPP Integration Analytical Track Project Summary / Abstract The Ohio Department of Agriculture (ODA) Consumer Protection Laboratory (CPL) proposes to enhance their laboratory information management system (LIMS) to allow for direct transfer of laboratory results to the FDA National Food Safety Data Exchange (NFSDX). This enhancement will allow laboratory information to be immediately accessible and linked to active FDA investigations through the Office of Regulatory Affairs Partners Portal (ORAPP). To accomplish this, ODA-CPL’s laboratory and IT team will work with the FDA NFSDX and ORAPP Teams as well as the development vendor for their LIMS, Acclaim, to identify gaps in reporting fields or formatting that need adjusted, present a final scope of work, authorize said work and put the finished product into production before the end of the project year. During this process ODA- CPL will collaborate in meetings with the NFSDX and ORAPP Teams for troubleshooting, guidance and identification of emergent issues during the implementation phase of the project. The laboratory will enter into a Memorandum of Understanding and Interconnection Security Agreement with the FDA as required for program participation. Lastly, the laboratory will participate in data exchange onboarding meetings and complete any FDA assignments related to NFSDX and ORAPP.