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

学科 D 特别项目 - 第 2 轨：NFSDX 和 ORAPP 集成

• 批准号: 10173387
• 负责人: Yong Liu
• 金额: $ 2万
• 依托单位: WA STATE DEPARTMENT OF AGRICULTURE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10173387
• 关键词: Discipline; Special; Project; Track; NFSDX

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

PAR-20-105：纪律D - 特殊项目 - 轨道2：NFSDX和ORAPP 项目摘要 WSDA食品安全和消费者服务（FS＆CS）实验室在此轨道上寻求资金 为了增强我们当前的数据系统以使我们能够电子提交样品测试数据 到FDA。我们要求一年的资金。我们更喜欢在第1年完成该项目 实验室灵活的资金模型，我们有以下成就和属性： WSDAFS＆CS实验室在2012年通过了实验室信息系统（LIMS）。 项目是一个合同的设计系统，我们能够修改，改进和增强 该系统已有8年。它继续为我们服务。 我们在LIMS和Elexnet之间建立了沟通。我们与FDA紧密合作 IT顾问数据库通信问题。我们通过电话会议和Webex见面 成功地在LIMS和ELEXNET之间提供联系，以便我们能够上传所有 我们的实验室数据进入Elexnet。 我们的实验室中有两个专用的LIMS管理员。他们接受了现场培训 在Lims供应商的网站上。我们的两个管理员都经验丰富，并且擅长维护 数据库。 如果我们的曲目2提案被接受，我们愿意并且能够做以下操作： 1。与FDA一起评估我们当前的IT功能。 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指南，我们将确定相关和 所需的数据字段，文件格式和实验室可以与之交换数据的机制 FDA。 3。参加数据交换会议并完成FDA问卷。 4。参加频率与FDA NFSDX和ORAPP团队的合作会议 由FDA确定。 5。进入理解备忘录（MOU）和互连安全协议 （ISA）与计划参与所需的FDA。 华盛顿州农业，食品安全和消费服务实验室