Notice ID: HT9425-25-NOI-LBA02
Related Notice: HT9425-25-RFI-LBA02
The United States Army Medical Research Acquisition Activity (USAMRAA), on behalf of the United States Army Medical Research and Development Command (USAMRDC) Enterprise Information Technology Project Management Office (eIT PMO) is issuing this notice of intent to award a new contract on a sole source basis. This is not a request for proposals.
The Government intends to award a sole source firm fixed price contract to ValGenesis, Inc (ValGenesis). The USAMRDC eIT PMO requires the procurement of a Validation Lifecycle Management System (VLMS) to streamline and improve its approach to validation lifecycle management and FDA compliance. Currently, this work is accomplished using a variety of applications and manual processes. Information is stored in different locations and formats making audits and overall regulatory compliance more challenging. The eIT PMO requires a single integrated solution to streamline the process and has found Software as a Service (SaaS) as a solution. Professional services are also required to properly configure the product for use. ValGenesis is the sole authorized licenser of the software and provider of maintenance and support for the VLMS. Additionally, ValGenesis has already successfully went through the DHA NIST Compliance Checklist and received their certificate to represent their self-certification. Failure to obtain VLMS and services directly from ValGenesis can lead to loss of on-going mission critical research milestones and data. The branded VLMS and annual services are the only item that will meet the current requirement. Award of this contract to any other contractor would result in unacceptable delays in USAMRDC’s research efforts and would not be cost effective, thereby justifying the limit source selection.
Required Capabilities: The VLMS must have the Minimum Essential Characteristics (MECs) as listed in the Request for Information (RFI)…
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