JOFOC FY26_Redacted.pdf

Contracting Officer.

☐ 41 USC 3304(a)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute / Brand

Name

IV. Demonstration that the proposed brand name product’s salient characteristics (specific features, qualities and/or the nature of the acquisition) requires use of the authority cited.

A. Name and address of the proposed contractor(s)

Global Cents

GCI LIVE, LLC

830 West Route 22, Suite 138 Lake Zurich, IL 60047

B. Describe why only the requested supply/service will meet the government’s needs

GCI PowerTools for Workflow and Deployments has been used since 2016 to assist with deploying document management and workflow solutions for NIAID and NIH. The GCI PowerTools Viewer is a versatile cost-effective solution for viewing and annotating documents directly within the OpenText Content Suite (OTCS) and Extended Enterprise Content Management platforms. The tool is an HTML5-based viewer that ensures high-quality dependable viewing for unlimited users eliminating the need for separate viewing servers and reducing associated costs. The GCI PowerTools Viewer supports Clinical Research and is critical for enabling regulatory compliance and data integrity for clinical trials artifacts in the Validated Enterprise Document Repository Management System (VEDRMS). The tool is integrated into VEDRMS to support clinical trials data and document management by allowing web-based, read-only viewing of clinical trials and research documentation. These documents are subject to regulatory audit and inspection and must maintain data integrity and audit trail for viewing at all times to meet regulatory requirements. This tool renders VEDRMS compliant with view-only access with no ability to download any data or artifacts from the repository which minimizes the risk of data being modified or disseminated without appropriate permissions. GCI PowerTools Viewer supports Clinical Research Studies by providing web-based, read-only viewing for controlled clinical trials artifacts and documentation to fully support regulatory compliance.

Clinical trial and research data must be kept in repositories that adhere to regulatory guidelines outlined by regulatory agencies like the Food and Drug Administration and the European Medical Association. These data and artifacts are controlled documents that require strict permissions and audit trails for 21 CFR Part 11 and Annex 11 compliance. All documents placed in this repository cannot be modified or will be at risk of compromising the clinical trials and research data contained within. The Viewer allows documents to be opened but not downloaded which nullifies the risk of document modification or non-controlled dissemination.

V . Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable Price reasonableness determination will be included in the acquisition file.

VI. Certification

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.