ValGenesis Clinical Validation Lifecycle Management Software Licenses and Support Renewalview on SAM.gov

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, redesi…