ValGenesis Clinical Validation Lifecycle Management Software Licenses and Support Renewal

This is a Notice of Intent and not a request for competitive quotations. The Government intends to solicit and negotiate directly with ValGenesis, Inc. No competitive solicitation is contemplated. The Department of Health and Human Services, Office of Mission Acquisition Solutions, on behalf of the National Institutes of Health, National Institute of Allergy and Infectious Diseases, intends to award a firm-fixed-price purchase order to ValGenesis, Inc. for the renewal of the ValGenesis Validation Lifecycle Management System software licenses and associated support services. The purpose of this requirement is to renew NIAID s existing subscription to the proprietary ValGenesis Validation Lifecycle Management System. ValGenesis VLMS provides NIAID with a centralized, controlled, secure, and auditable platform for managing Computer System Validation and Computer System Assurance activities associated with regulated, quality-sensitive, and mission-supporting systems and processes. The ValGenesis platform supports validation planning, risk assessments, requirements traceability, test protocol development and execution, deviation tracking, controlled document management, audit trails, reporting, and retention of validation records. The software enables NIAID to standardize validation activities, maintain data integrity, reduce the risk of human error, and demonstrate that clinical and mission-supporting systems are fit for their intended use and compliant with applicable regulatory and quality requirements. The requirement includes the following: ValGenesis VLMS Subscription Renewal Quantity: One annual subscription Named User Licenses Quantity: 40 Named User Licenses Read/Approve Licenses Quantity: 10 Read/Approve Licenses Software Maintenance and Technical Support Includes the associated maintenance, updates, patches, and technical support required to maintain NIAID s existing ValGenesis environment. Period of Performance: August 12, 2026 through July 31, 2027. Justification for Sole Source ValGenesis, Inc. is the developer, owner, sole provider, and only authorized source for the proprietary ValGenesis VLMS software licenses and associated support services. ValGenesis has confirmed that it does not license the software or provide support services through resellers, distributors, or other third parties. Accordingly, ValGenesis, Inc. is the only entity qualified and authorized to provide the required licenses and product-specific support services. NIAID s validation lifecycle processes, configurations, templates, records, workflows, user practices, and controlled documentation are currently aligned with the ValGenesis VLMS environment. Continued use of the existing platform is necessary to maintain compatibility with NIAID s current configurations, validation records, operational workflows, audit trails, historical documentation, and validated system state. Transitioning to another platform would require substantial data and document migration, redesign and reconfiguration of established workflows, system testing, user retraining, cybersecurity review, and partial or complete revalidation of affected processes and system controls. These activities would result in substantial duplication of cost, unacceptable schedule delays, increased compliance and data-integrity risks, and potential disruption to ongoing NIAID operations. Although other vendors may offer validation, quality management, or document management products, those products cannot provide the proprietary ValGenesis platform, vendor-controlled subscription rights, authorized maintenance, product updates, technical support, or direct continuity with NIAID s existing validated environment. Market research determined that no other source can satisfy the Government s actual requirement without substantial duplication of cost, unacceptable delay, and increased performance and compliance risk. Authority This acquisition is being conducted under FAR Part 12, Acquisition of Commercial Products and Commercial Services, and FAR Part 13, Simplified Acquisition Procedures. Pursuant to FAR 13.106-1(b)(1), for acquisitions not exceeding the Simplified Acquisition Threshold, a contracting officer may solicit from one source when the contracting officer determines that the circumstances of the contract action make only one source reasonably available. Contracts awarded using FAR Part 13 simplified acquisition procedures are generally exempt from the competition requirements of FAR Part 6. Submission of Capability Statements Interested parties that believe they are capable of providing the exact ValGenesis VLMS licenses and associated support services described in this notice must submit a capability statement electronically. Capability statements will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government to proceed with the intended sole source acquisition, based upon responses to this notice, is solely within the discretion of the Government. Capability statements must demonstrate the party s ability to provide the exact ValGenesis VLMS subscription, including 40 Named User Licenses, 10 Read/Approve Licenses, and all associated software maintenance, updates, patches, and technical support. Responses must also include documentation demonstrating that the responding party is authorized by ValGenesis, Inc. to provide the required proprietary software licenses and product-specific support services. Responses proposing an alternative software product without demonstrating the ability to provide the exact proprietary ValGenesis VLMS licenses and authorized support services will not satisfy the Government s requirement. Deadline: August 10, 2026, at 1:00 PM Eastern Time Submit to: Vera Nordalm Contract Specialist Office of Mission Acquisition Solutions (OMAS) Email: vera.nordalm@hhs.gov The email subject line must reference ValGenesis Clinical Validation Lifecycle Management Software Renewal NOI 7571TE26Q00162.