DHA Sources Sought: Enterprise Information Technology Project Management Office (eIT PMO) Validation Lifecycle Management System (VLMS) with Maintenance, Technical Services and Support

Notice ID: HT9425-25-RFI-LBA02

The 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.

Minimum Essential Characteristics:

• Software License & Maintenance
  • Software shall be able to cover the entire FDA computing system validation lifecycle.
  • Software shall be a paperless solution for electronic management of validation execution and approval.
  • Software shall be able to accept test scripts in MS Word and convert them to paperless testing.
  • Software shall be a central system and provide web-based interface …

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