Description
The Defense Health Agency Contracting Activity (DHACA) is seeking a contractor to provide Electronic Common Technical Document (eCTD) software licenses, maintenance, technical support services, and training for eCTD publishing and reviewing software products and modules. The contractor will be required to supply software licenses, provide technical support services, and offer training to users. The contract has a base period of 12 months, with four one-year renewable options and a six-month extension. The contractor must demonstrate their understanding of the requirements and provide a technical approach that meets the needs of the agency. Some key features of the required software include the ability to interface with OpenText Content Server 22.4, support for Microsoft Windows Server 2019 R2 (64-bit) operating system, and compliance with FDA 21 CFR Part 11 requirements.
• The contractor must provide eCTD software licenses and maintenance for 12 user accounts and up to 50 named reviewer accounts.
• The contractor must provide technical support services, including resolving application problems and providing training to users.
• The contractor must provide FDA-mandated submission templates and technical support for these templates.
• The contractor must provide non-personal services to support regulatory questions by eCTD publishers.
• The contractor must demonstrate their experience with similar projects and provide a management approach that ensures successful completion of the contract.
Attached files
Contact
Toloria DuVall