Validation Lifecycle Management System (VLMS)
ID: HT9425-25-NOI-LBA02Type: Presolicitation
Overview

Buyer

DEPT OF DEFENSEDEFENSE HEALTH AGENCY (DHA)ARMY MED RES ACQ ACTIVITYFORT DETRICK, MD, 21702, USA

NAICS

Custom Computer Programming Services (541511)

PSC

IT AND TELECOM - BUSINESS APPLICATION/APPLICATION DEVELOPMENT SOFTWARE AS A SERVICE (DA10)

Original Source

https://sam.gov/opp/7679f4aa6fb64ea2a49fabbfb1c4248f/view
Timeline
    Description

    The Department of Defense, through the Defense Health Agency (DHA), is seeking to award a sole source contract for a Validation Lifecycle Management System (VLMS) to ValGenesis, Inc. This procurement aims to streamline validation lifecycle management processes and enhance compliance with FDA regulations, addressing the complexities of current methods that involve multiple applications and manual processes. The VLMS is critical for ensuring efficient audits and regulatory compliance, and ValGenesis is the sole authorized provider of this software, having met necessary compliance evaluations. Interested vendors must provide evidence of their capability to deliver similar services within 15 days of this notification, and inquiries can be directed to Lindsey Arthur or Justin Pickett via their respective emails.

    Point(s) of Contact
    Lindsey Arthur
    lindsey.b.arthur2.civ@health.mil
    Justin Pickett
    justin.h.pickett.civ@health.mil
    Files
    Title
    Posted
    HT9425-25-NOI-LBA02.pdf
    The United States Army Medical Research Acquisition Activity (USAMRAA) intends to award a sole source contract to ValGenesis, Inc. for a Validation Lifecycle Management System (VLMS). This decision stems from the need to streamline validation lifecycle management and enhance FDA compliance, as current methods involve multiple applications and manual processes, complicating audits and regulatory compliance. ValGenesis is identified as the sole authorized provider of this software, having passed necessary compliance evaluations. The Government emphasizes that procuring the VLMS from any other source could jeopardize critical research milestones and would not be cost-effective, thus justifying the sole source selection. Interested vendors must provide evidence of their capability to deliver similar services within 15 days of this notification to be considered for competitive procurement. Questions regarding the contract can be directed to the listed contract specialist.
    Lifecycle
    Title
    Type
    Validation Lifecycle Management System (VLMS)
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