Amendment 1 to Quality Management Information System (QMiS) Admin Support

****Statement of Work, dated 13 May 2020, is deleted. Statement of Work, dated 19 May 2020, is added**** *********Please see the attached Amendment 1 with answers to all questions submitted on time.************** Background The U. S. Food and Drug Administration (FDA), Office of Testing and Research (OTR) in St. Louis, MO focuses on creating and maintaining a quality management system (QMS) with the laboratory that is compliant with the international standards for testing laboratories, specifically ISO 17025. This focus has increased the need for managing and accessing information critical to the operation of the laboratory. Managing a QMS plays a critical role in assuring the accuracy and precision of laboratory results so that they are reliable, interpretable, repeatable, and defensible. The laboratory is in need of a software platform for automating and effectively managing quality processes critical to regulatory compliance, otherwise known as a Quality Management Information System (QMiS). Objective OTR in St. Louis intends to place a firm-fixed price order for the maintenance services and additional technical support services to the Quality Management Information System (QMiS). The required professional services from the contractor to provide system administrator support to ensure the QMiS is managed effectively. Instructions to Quoters This solicitation is issued under FAR Part 12 and 13.5 procedures. This is a small business set aside procurement. The NAICS code is 518210. The small business size standard is $35 Million. Quoters responding to this RFQ must be registered with an Active status in the System for Award Management (SAM): www.sam.gov. Please submit separated technical and business responses to this requirement: Volume One – Technical Brief narrative description of the Quoter’s understanding and approach to meet all technical requirements. Staffing plan. This should include the availability and names of the individuals, a description of their roles in performing the work required, and the amount of time that you anticipate the individuals will dedicate to this requirement. It should also indicate which, if any, personnel are employees of the prime or subcontractor. Volume One shall not exceed 10 pages in length. Volume One shall not include any pricing information. Volume Two – Pricing Quotes must be firm fixed price. Total pricing for the acquired services, including cost of travel needed to visit OTR site in Silver Spring, MD. Any notes or assumptions shall not conflict with the RFQ. Partial/incomplete pricing or pricing with omissions may not be considered for award. Quoters shall certify their quotes to be valid for 30 days. Please submit questions to Min Jie (Terry) Zeng via email at [email protected] by May 15, 2020, 12PM Eastern Time. Please submit quotes to Min Jie (Terry) Zeng via email at [email protected] by May 22, 2020, 12PM Eastern Time. Evaluation Criteria The Government will award a contract resulting from this solicitation to the responsible quoter as a firm fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation should contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.