This Government Contract opportunity from Iowa was posted on May 4, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Regulatory Compliance and Validation Services
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
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The contract requires comprehensive validation of a Laboratory Information Management System to ensure full compliance with regulatory standards set by the FDA, CLIA, CAP, and AABB. This includes the development of detailed validation protocols, execution of rigorous test scripts, and thorough documentation of audit trails to demonstrate system integrity and data reliability. All activities must be performed in alignment with industry best practices and regulatory expectations to support laboratory operations in clinical and biological testing environments. The subcontract is issued by the University of Iowa under NAICS code 541611 and is open for response until June 9, 2026. The work is expected to be performed without specified geographic restrictions, and the solicitation is not set aside for any specific small business category. Interested parties must submit their proposals by the stated deadline to be considered for award, with all deliverables focused on achieving and maintaining regulatory compliance through structured, auditable validation processes.
General Info
Agency
NAICS
Place of Performance
IA, USASet-Aside
Documents
This scope was carved out of RFI 18597.
The full solicitation package (3 documents), including the RFP, is on the prime solicitation, not on this scope.
Request For Information: Tissue and Cellular Therapy Laboratory Information Management System
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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