SOURCES SOUGHT
D -- Electronic Laboratory Notebook / Laboratory Information Management System
- Notice Date
- 10/27/2011
- Notice Type
- Sources Sought
- NAICS
- 541512
— Computer Systems Design Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- P12-001158
- Point of Contact
- Darren H. Liu, Phone: 301-496-1199
- E-Mail Address
-
darren.liu@nih.gov
(darren.liu@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought/Market Survey Notification The National Institutes of Health, Clinical Center (NIH CC) Positron Emission Tomography (PET) Department in Bethesda Maryland is conducting a market survey/sources sought to help determine the availability and technical capability of qualified small businesses, veteran-owned small businesses, service disabled veteran-owned small businesses and/or HUBZONE small business capable of serving the needs mentioned below. This market survey/sources sought announcement is not a request for proposals and the Government is not committed to award a contract pursuant to this announcement. The information from this market research is for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research and the Government will not entertain questions concerning this market research. The Government will not pay for any costs incurred in the preparation of information for responding to this market survey. The NIH PET cGMP Production Facility located on the Bethesda campus needs a commercially available software based program for its clinical PET Drug manufacturing and testing facility. This electronic solution shall be a Laboratory Informatics System. Such a system shall be customizable, be able to capture laboratory data electronically and re-populate the information dynamically into electronic forms. It shall be interactive and user friendly with minimum learning curve. Parties interested in responding to this market research survey shall demonstrate the qualifications to perform required work by providing information on personnel, equipment, facilities, supplies, and technical capabilities, to provide the following system and support: System Requirement - FDA Regulatory Compliance - To Ensure the PET cGMP Production Facility is 21 CFR Part 11 Compliant. - Dynamic Field Entry, Dynamic upload of data - Production and QC data must be captured into the e-worksheet(s) as lab data becomes available. - Form Generation - User friendly and fillable e-forms capable to accommodate the short turn around time from start of production to final product release. - Administration - Low maintenance and user friendly interface to accommodate in-house administration and support. Creation and revision of electronic process and e-worksheets and e-forms should be simple and user friendly. - Batch Tracking - Ability to track sample batches via an alpha numeric naming convention for each batch (e.g. FDP 235). - Multiple Nodes of Entry - Ability to be accessed by multiple people simultaneously for the same and/or different products. - PET Drug Tracking - Batch tracking with ability to provide a status screen to indicate the live flow for each batch at all times during the process. - Chemical Inventory - Ability for inventory tracking, send reminders for low supplies or near expiration. Should also include the ability to document the preparation and track the use of all solutions and buffers prepared in house. System should also be able to create customizable barcode labels for easy entry of sample information. - Reporting - System should be able to parse data from existing reports (e.g. PDF) or instrument generated raw data files (Microsoft *.rpt file, *.csv file, etc). System should have calculation abilities similar to Excel. It should have the ability to assign pass/fail check based on established specification limits in order to generate a Certificate of Analysis type report. The system should be able to generate an investigation/ OOS report upon failure to meet one or more of the specifications or upon deviation from accepted method. - Analog Data Capture - Ability to download /communicate with analytical instruments (balances and pH meters) to capture data generated by these instruments through instrument serial output. - Calibration Check - To keep track of calibration, verification, and suitability of instruments used within the production and QC laboratories. The system should be able to maintain the equipment calibration information, in addition to suitability and maintenance records. - Document Control - Keep track of final approved and old versions of Standard Operating Procedure (SOP), forms and other controlled documents. The System should also be able to route controlled documents for review and approval process. - Training - To provide training to all personnel and track training requirements. The System should set reminders, and keep a record of personnel trainings. - Support and Maintenance - Provide telephone or onsite support to isolate and resolve problems System Support and Related Service Duration System support and related service will be performed for a year and the Government may extend the service up to four additional years with the use of annual options in accordance with FAR Subpart 17.2. The vendor response shall also include any other specific and relevant information related to the requirements of this project that will enable the Government to determine the capabilities of the interested party to perform the specialized requirements described in this synopsis. Interested organizations must demonstrate and document in any response submitted, to this market survey extensive experience with and the ability to perform all of the specialized requirements elsewhere described. This notice is a market survey and is for information and planning purposes only and does not commit the Government to any contractual agreement. THIS IS NOT A REQUEST FOR PROPOSALS. The Government will not award a Purchase Order or Contract based upon Vendor responses to this announcement. The Government shall not assume any costs for preparing or submitting any information in response to the market survey or the Government's use of the information. Any proprietary information should be clearly identified as "proprietary information". Vendors must send written capability responses by November 10, 2011 to the Contract Specialist at the following e-mail address darren.liu@nih.gov. The written responses must also indicate the size of your firm- small businesses, veteran-owned small businesses, service disabled veteran-owned small businesses and/or HUBZONE small business for any questions, please contact the Contract Specialist, Mr. Darren Liu at (301) 496-1199.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/P12-001158/listing.html)
- Place of Performance
- Address: National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02613892-W 20111029/111027234247-180350e0539ce3783dcc87ce5385ddcd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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