Discipline D Special Project - Track 2: NFSDX and ORAPP Integration

PAR-20-105：学科D-特别项目-轨道2：NFSDX和ORAPP 项目摘要 WSDA食品安全和消费者服务(FS&CS)实验室在#年为这一轨道寻求资金 以加强我们现有的数据系统，使我们能够以电子方式提交样本测试数据 给食品和药物管理局。我们要求提供一年的资金。我们希望在第一年完成这个项目。 实验室灵活资助模式，我们有以下成就和属性： WSDA FS&CS实验室于2012年通过了实验室信息系统。这个IT 项目是一个签约的设计系统，我们已经能够修改、改进和提高 这一制度已经实施了8年。它继续为我们提供良好的服务。 我们建立了我们的LIMS和eLexnet之间的通信。我们与FDA密切合作 就数据库通信问题提供信息技术咨询。我们通过电话会议和WebEx会面，以 成功地在我们的LIMS和eLEXNET之间提供链接，以便我们能够上传所有 将我们的实验室数据输入eLEXNET。 我们的实验室里有两名专职的LIMS管理员。他们接受了现场培训 在LIMS供应商的网站上。我们的两位管理员都经验丰富，擅长维护 数据库。 如果我们的第二轨道建议被接受，我们愿意并能够做到以下几点： 1.与FDA一起评估我们当前的IT能力。 2.通过与NFSDX集成或采用ORA合作伙伴门户来增强实验室IT系统 通过上传实验室数据文件。根据FDA的指导，我们将确定相关和 实验室交换数据所需的数据字段、文件格式和机制 美国食品和药物管理局。 3.参加数据交流会，填写FDA问卷。 4.经常参加与FDA NFSDX和ORAPP团队的协作会议 由FDA确定。 5.签订谅解备忘录和互联互通安全协议 (ISA)根据参与计划的要求与FDA合作。 华盛顿州农业、食品安全和消费者服务实验室

PAR-20-105: Discipline D – Special Projects - Track 2: NFSDX and ORAPP Project Summary The WSDA Food Safety and Consumer Services (FS&CS) Laboratory seeks funding for this track in order to enhance our current data systems to enable us to electronically submit sample testing data to FDA. We request funding for one year. We prefer to complete this project in Year 1 of the Laboratory Flexible Funding Model, and we have the following accomplishments and attributes:  The WSDA FS&CS Laboratory adopted a Laboratory Information System (LIMS) in 2012. This IT project was a contracted design system and we have been able to revise, improve and enhance the system for 8 years. It has continued to serve us well.  We established communication between our LIMS and eLEXNET. We worked closely with FDA IT consultants on database communication issues. We met via conference call and WebEx to successfully provide linkage between our LIMS and eLEXNET so that we are able to upload all of our laboratory data into eLEXNET.  We have two dedicated LIMS administrators in our laboratory. They have received onsite training at the LIMS vendor’s site. Both of our administrators are experienced and skilled at maintaining databases. If our Track 2 proposal is accepted, we are willing and able to do the following: 1. Assess our current IT capabilities in conjunction with FDA. 2. Enhance the laboratory IT system by integrating with NFSDX or adopting ORA Partners Portal by uploading laboratory data files. Based on FDA guidance, we will determine the relevant and required data fields, file formats and mechanism by which the lab can exchange data with FDA. 3. Participate in data exchange meetings and complete the FDA questionnaire. 4. Attend collaboration meetings with FDA NFSDX and ORAPP teams at the frequency determined by FDA. 5. Enter into a Memorandum of Understanding (MOU) and Interconnection Security Agreement (ISA) with FDA as required for program participation. Washington State Department of Agriculture, Food Safety and Consumer Services Laboratory