MasterControl Software-as-a-Service for Electronic Quality Management System
ID: NIAID-NOI-26-2277932Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIAIDBETHESDA, MD, 20892, USA

NAICS

Software Publishers (513210)

PSC

IT AND TELECOM - BUSINESS APPLICATION/APPLICATION DEVELOPMENT SOFTWARE AS A SERVICE (DA10)

Set Aside

No Set aside used (NONE)
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to procure MasterControl Software-as-a-Service (SaaS) for its Electronic Quality Management System (eQMS) to support the Clinical Quality Management System (CQMS) at the National Institute of Allergy and Infectious Diseases (NIAID). This procurement is intended to ensure compliance with federal and international regulations by managing controlled documents and quality processes related to clinical trials sponsored by NIAID. The MasterControl software has been utilized since 2019 and is critical for managing documentation, training, and regulatory audits, with a contract period of performance from January 1, 2026, to December 31, 2026. Interested vendors may submit their capabilities statements to Linda Smith at linda.smith2@nih.gov within 10 days of this notice, as the government intends to award a sole source contract based on the unique capabilities of MasterControl Solutions.

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