Special Project NFSDX Integration or ORAPP Adoption Analytical Track

提高…的能力和容量

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.