United States Army Medical Research and Development Command

Buyer requires a Validation Lifecycle Management System (VLMS) to streamline FDA compliance and validation lifecycle management. The system should be a SaaS solution covering the entire FDA computing system validation lifecycle. Buyer needs professional services for configuration, training, and ongoing maintenance. The solution must comply with FDA 21 CFR Part 11 requirements and DHA NIST compliance standards.

• 10/18/2024 - Proposal Due Date

• Provide SaaS solution for FDA computing system validation lifecycle management
• Implement paperless solution for electronic management of validation execution and approval
• Configure product for eIT PMO use
• Offer professional services for initial setup and configuration
• Provide training for basic end users and product administrators
• Ensure compliance with FDA 21 CFR Part 11 requirements
• Implement role-based security for authorized user access
• Create integrations with other software packages like Gitlab, Leapwork, and Jira
• Maintain software with major and minor releases and patch management
• Provide data backup and retention strategy