The purpose of this requirement is to determine and prioritize functional and technical requirements that meet the regulatory and compliance needs of the National Institute of Allergy and Infectious Diseases (NIAID) Intramural and Extramural Divisions and to understand the technology system and tool landscape for electronic Quality Management Systems and electronic Trial Master Files.
Specifically, NIAID is seeking:
- Commercial off-the-shelf (COTS) Electronic Quality Management System (eQMS) that can scale to support multiple divisions within NIAID.
- COTS Electronic Trial Master File (eTMF) that can scale to support multiple divisions within NIAID.
- Professional services to configure, deploy, train, validate, migrate existing documents, and support NIAID’s use and adoption of the eQMS and eTMF systems.
- Ongoing support including maintaining compliance with changing regulatory requirements and mitigation of security vulnerabilities.