MODIFICATION
D -- Quality Management Information System
- Notice Date
- 6/27/2016
- Notice Type
- Modification/Amendment
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-16-QMIS
- Archive Date
- 7/26/2016
- Point of Contact
- Jody L. OKash, Phone: 2404024996
- E-Mail Address
-
jody.okash@fda.hhs.gov
(jody.okash@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A SOURCES SOUGHT NOTICE FOR INFORMATION AND ACQUISITION PLANNING PURPOSES ONLY. This is not a request for quote or proposal. This notice does not constitute a commitment by the Government to issue an RFP, RFQ, contract, or order. The Government will not pay for any effort expended or any material provided in response to this announcement. Requests for a solicitation will not receive a response. This Sources Sought is being issued by the Food and Drug Administration (FDA) for the purchase, configuration, implementation, and support of a Commercial-Off-the-Shelf (COTs) Quality Management Software solution that will assist the FDA with the following high-level requirements: a. Capture, track, and trend Work Product Non Conformance b. Capture, track, and trend Corrective and Preventative Actions c. Compile Audits and Assessments d. Follow and implement industry best practices e. Store Standard Operating Procedures The interested vendors must submit a completed requirements capability matrix with their capability statement (see attachment 1). The matrix provides selections that will allow the vendor to identify to what extent the proposed COTS Quality Management Software can meet the features and functionalities out of the box or if additional configurations / customizations are needed. The interested vendor shall identify any additional features / functionalities the recommended product can provide that are not identified in the attached requirements capability matrix. In addition, the interested vendor shall identify to what extent the COTs tool is capable of complying with the following 508 Standards by submitting a completed Product Accessibility Template (PAT): SECTION SUBSECTION STANDARD DESCRIPTION 1194.21 a, b, c, d, e, f, g, h, i, j, k,l Software applications and operating systems 1194.22 a, d, e, f, g, h, I, j, k, l, m, o, p Web-based intranet and internet information and applications 1194.41 a, b, c Information, documentation, and support. The contractor shall also provide the following Business Information for both the seller and manufacturer of the product (if different): 1. Company's experience conducting Agile Development 2. Company's experience supporting users of the recommended COTs Quality Management Software stationed across multiple geographic areas 3. Company's experience implementing the recommended COTs Quality Management Software. 4. DUNS Number 5. Company Name 6. Company Address. 7. Company Point of Contact, phone number and email address 8. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. 9. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 10. Current GSA Schedules appropriate to this Sources Sought 11. Current Government Wide Agency Contracts (GWACs) 12. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. 13. Any applicable Socio-Economical Classification(s): 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, Women-Owned and Small Disadvantaged Business. 14. The interested vendor is encouraged to submit any commercial / catalog pricing for their recommended solution. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. SUBMISSION INSTRUCTIONS Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email. Please note, the Government reserves the right to schedule interviews and / or product demonstrations with vendors. Responses shall be limited to 15 pages. Responses must be received in writing, no later than Monday July 11, 4:30 PM, Eastern Time. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Jody OKash at Jody.OKash@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-16-QMIS/listing.html)
- Place of Performance
- Address: To be determined, United States
- Record
- SN04162744-W 20160629/160627234428-a5b71237716cc6a2f23efe293d8e84b0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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