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MasterControl Software-as-a-Service for Electronic Quality Management System   2

ID: JA-NIAID-24-2216266 • Type: Justification • Match:  85%
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Description

See attached sole source justification.

Background
The National Institute of Allergy and Infectious Diseases (NIAID) requires the MasterControl Software-as-a-Service (SaaS) for its Electronic Quality Management System (eQMS) to manage controlled documents and quality processes as a Sponsor of clinical trials.

This service is crucial for maintaining regulatory compliance across multiple groups within NIAID.

Work Details
The contract involves providing MasterControl Qx Complete SaaS licenses, which include full and view-only licenses that require annual renewal.

The software automates the lifecycle of quality-related documents, manages quality processes such as audits and training, and supports multiple NIAID divisions with specific process workflows.

It is a FISMA/FedRAMP certified solution that ensures regulatory compliance.

Period of Performance
July 1, 2024 – June 30, 2025

Place of Performance
NIAID facilities

Overview

Agency
National Institutes of Health (NIH) [HHS]
Award Date
July 1, 2024
Response Deadline
None
Posted
July 1, 2024, 5:32 p.m. EDT
Set Aside
None
NAICS
513210 - Software Publishers
PSC
DA10 - IT And Telecom - Business Application/Application Development Software As A Service
Place of Performance
Rockville, MD 20852 United States
Source
Open
Current SBA Size Standard
$47 Million
Pricing
Likely Fixed Price
Est. Level of Competition
Sole Source
Est. Value Range
Experimental
$500,000 - $1,500,000 (AI estimate)
On 7/1/24 National Institutes of Health issued Justification JA-NIAID-24-2216266 for MasterControl Software-as-a-Service for Electronic Quality Management System.
Primary Contact
Name
Tamara McDermott   Profile
Email
tamara.mcdermott@nih.gov
Phone
None

Documents

Posted documents for Justification JA-NIAID-24-2216266

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Opportunity Lifecycle

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > NATIONAL INSTITUTES OF HEALTH > NATIONAL INSTITUTES OF HEALTH NIAID
FPDS Organization Code
7529-00310
Source Organization Code
100188096
Last Updated
July 31, 2024
Last Updated By
tamara.mcdermott@nih.gov
Archive Date
July 31, 2024