The United States Army Medical Research and Development Command (USAMRDC) has issued a Request for Information (RFI) seeking proposals for a Validation Lifecycle Management System (VLMS) to enhance its validation lifecycle and ensure FDA compliance. The current validation processes are fragmented, relying on various applications and manual workflows. The preferred system is a Software as a Service (SaaS) solution that enables electronic management and improves regulatory audits. Key requirements include comprehensive software features to cover FDA validation processes, role-based access control, a secure central document repository, and the ability to raise alerts for overdue tasks. The vendor must provide professional setup, training, and ongoing software maintenance, including major and minor updates. Additionally, the system must adhere to FDA 21 CFR Part 11 regulations and pass the Defense Health Agency's NIST compliance requirements. Interested parties are encouraged to submit a Capability Statement by October 18, 2024, outlining their qualifications and complying with specific format guidelines. This RFI serves to gather market knowledge and does not constitute a formal solicitation. Confidentiality is emphasized, prohibiting the inclusion of sensitive information in responses. The underlying aim is to procure a cohesive solution to streamline validation operations within the USAMRDC.