Description
The FDA is seeking information from potential vendors for a Karl Fischer Titrator (KFT) or equivalent system to replace an older KFT system. The system must meet specific requirements, including compliance with ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR Part 11. The system should be a modular design, controlled by instrument controller software, and include various components such as a Dynamic Dosing Unit, titration stand, and solvent and waste bottles. The vendor must provide a complete workstation, installation, training, and maintenance services.
• The system must be a newly manufactured unit, not used or refurbished.
• The vendor must provide all necessary hardware, software, and documentation.
• The system must be delivered, installed, and qualified within 90 days of contract award.
• The vendor must provide on-site operator training and maintenance services.
• The system must be warranted for at least one year from FDA acceptance.