FDA Sources Sought: Quality Management Information System (QMiS) Licenses and IT Professional Services

Notice ID:  75F40124Q00270

Background:   This is Sources Sought Request for Information (RFI) to identify potential small businesses who are interested and capable to meet Food and Drug Administration’s requirements of seeking Commercial Off-the-Shelf software licenses and professional IT services to enhance and support the current Quality Management Information System (QMiS) iterations in Office of Pharmaceutical Quality (OPQ), both laboratory based and non-laboratory based, as well as merge the two systems and transition to the Cloud environment. Please review Attachment 1 – Draft Statement of Work for detail information on the requirements.

This Statement of Work (SOW) is for Software and Services to support the enhancement and maintenance of a Quality Management Information System (QMiS) for the Office of Pharmaceutical Quality within the Food and Drug Administration (FDA) to ensure compliance with FDA Standard Manual Guide (SMG) 2020, FDA Quality System Framework for Internal Activities. The purpose of this initiative is to:

• Promote standardization
• Improve process consistency
• Increase efficiency
• Provide a comprehensive approach to quality and compliance by continuing to operate with:
• Commercial off-the-shelf (COTS) QMiS software known as MasterControl that can interoperate and scale to support OPQ
• Professional services to configure, deploy, train, validate, migrate existing documents, and support FDA’s use and adoption of the QMiS.

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government, as needed to perform this Statement of Work.

Scope.  The scope of this procurement is to acquire Commercial Off-the-Shelf software licenses and professional IT services to enhance and support the current QMiS iterations in OPQ, both laboratory based and nonlaboratory based, as well as merge the two systems and transition to the Cloud environment. The system is built for use by OPQ that can be expanded for us by other CDER offices in the future. For OPQ, the QMS governs the core processes (Assessment, Surveillance, Research, Policy, Inspection) within the office, and will be used by all staff (approx. 1400) when fully implemented.

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