HT9425-25-NOI-LBA02.pdf

Notice of Intent to Sole Source (HT9425-25-NOI-LBA02)

Title: Validation Lifecycle Management System (VLMS)

NAICS: 541511

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. This notice does not represent a commitment by the Government to pay for costs incurred from the preparation and/or submission of data in response to this notice.

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).

This contract will be issued on a sole source basis. The North American Industry Classification System (NAICS) code for this requirement is 541511 – Custom Computer Programming Services. Any sources that believe they are eligible and capable of providing this product must respond in writing. Responses must be supported with clear and convincing evidence articulating the ability to provide the items outlined above. A request for documentation will not be considered an affirmative response. Information received will be considered solely for the purposes of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects fifteen

(15) days after the publication of this notice, the modification will be awarded without further remark.

This notice is provided solely as information to the marketplace.

CONTACT INFORMATION: Questions may be submitted to Lindsey Arthur, Contract Specialist at lindsey.b.arthur2.civ@health.mil.

mailto:lindsey.b.arthur2.civ@health.mil