SOLICITATION NOTICE
66 -- NuGenesis LMS
- Notice Date
- 7/19/2019
- Notice Type
- Combine Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 4041 Powder Mill Road Beltsville MD 20705
- ZIP Code
- 20705
- Solicitation Number
- FDA-19-RFQ-1217373
- Response Due
- 7/26/2019
- Point of Contact
- Todd J Johnston, Contract Specialist, Phone 301-232-3770
- E-Mail Address
-
Todd.Johnston@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- 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. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (19-JUL-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-19-RFQ-1217373/listing.html)
- Record
- SN05375905-F 20190721/190719230029 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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