NuGenesis LMS
The U.S. Food and Drug Administration (FDA), San Juan Laboratory in the Office of Regulatory Science, Office of Medical Products, Tobacco, and Specialty Laboratory Operations, located at 466 Fernandez Juncos Ave., San Juan, Puerto Rico 00901 uses multiple types of data collection and management systems. As a Pharma Specialty Laboratory, the San Juan Laboratory needs a wide variety of analytical instrumentation and data acquisition systems that provide the versatility needed to perform a large variety of analytical methods. These include an existing NuGenesis ELN/SDMS (ELN, electronic laboratory notebook/ SDMS, scientific data management system) data system. NuGenesis allows the San Juan Laboratory to collect, store, and manage electronic data and reports from multiple types of instrument controller software. The electronic data can be included in results packages but does not currently have traceable user/analyst information. The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2005, ISO 9001:2008, and 21 CFR 11 standards for use under the current accreditation, as well as comply with the current ORA Laboratory Manual. Six additional named user licenses will give each analyst at the San Juan Laboratory an individual account that will allow each analyst the ability to make traceable annotations, data will be name/date/time stamped and can be signed using an individual's signature. This adds traceability to the records, audit trail, and final reported results. In addition, this allows analysts to secure and manage their own data, preferences, and reports with a unique user ID and login password.
This is being solicited as a brand name or equivalent requirement. The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The Contractor shall provide six (6) NuGenesis User Licenses for the San Juan Laboratory.
The Government intends to issue a firm fixed-price purchase order as result of this solicitation. Please see the attached RFQ for complete requirement details and quotation submission instructions.
Todd J Johnston, Contract Specialist, Phone 301-232-3770, Email Todd.Johnston@fda.hhs.gov
