Federal Supply Schedule Limited-Sources Justification Summary

This document is a Federal Supply Schedule Limited-Sources Justification for a modification to an existing contract. The FDA is extending the Quality Management Information System (QMIS) Bridge Contract (47QTCA20D00CG/75F40125F80091) with CWC Group, LLC for an additional three-month period from October 21, 2026 through January 20, 2027. The estimated value of this modification is $1,811,111.00, representing an increase of $644,200.00 to the original contract value. The extension provides time for the incumbent contractor to transition system information to a future cloud-based QMIS vendor and migrate existing data to a platform accessible by the new vendor. CWC Group, LLC is located at 16701 Melford Boulevard, Suite 400, Bowie, MD 20715.

The justification for limiting sources is based on the principle that this work represents a logical follow-on to the original Federal Supply Schedule order placed in accordance with applicable FSS ordering procedures. The QMIS is an on-premises system built on MasterControl Commercial Off-The-Shelf (COTS) software, and support services can only be obtained from CWC Group, LLC. The incumbent contractor, identified as an economically disadvantaged woman-owned small business, has operated and maintained the MasterControl on-premises Classic20 QMIS since approximately 2020. Oil has utilized QMIS since 2009, while CBER has relied on the system for five or more years. The pricing structure is firm-fixed price. The contracting officer determined the modification represents best value to the Government based on level of effort, independent government estimates, and non-certified cost and pricing information.