Our team of highly experienced Field Service Engineers understand cGMP regulations and validation requirements. They provide the expertise you need to set up and validate your system quickly and easily at optimal performances.
Factory Acceptance Testing (FAT) is the most cost-effective means to ensure your system operates correctly – before installation.
Quality control, visual inspection, functional evaluation, and documentation verification are all part of Millipore’s Factory Acceptance Testing. FAT is performed at one of Millipore’s state-of-the-art facilities by our technical experts -- in accordance with design specification and current Good Manufacturing Practices (cGMP).
Developed by our team of technical experts who understand cGMP regulations and validation requirements, Millipore’s protocol contains procedures and acceptance criteria to ensure your system is fully operational and easily validated on-site.
Aimed at shortening validation time and reducing paperwork, our protocols assist in saving time of your busy QA departments.
Our protocols contain all the information and necessary result worksheets you need to support the organization, execution and recording of the validation step by step.
When you need additional support at your site location to execute our protocols, our field service engineers can assist you.
This service includes one on-site visit by a trained Millipore field service engineer to perform the Commissioning, Installation and Operational Qualification according to our Protocol. The protocol is executed in compliance with cGMP regulations.
This service also includes basic user training, enabling operators to efficiently use the equipment immediately following setup.
Millipore can also offer on-site support for determination of Performance Qualification (PQ) tests and data analysis.
Support the development and compliance needs of your personnel with Millipore’s extensive selection of high quality training and certification courses. Training includes workshops, lectures, hands-on exercises, and case studies conducted in our worldwide training centers, and at your facility.
Courses range from 1-5 days, and are designed to help biopharmaceutical manufacturers meet critical needs for process efficiency and cGMP compliance
Our technical support groups are there when you need them, offering over-the-phone advice on applications and systems use. If you require an on-site visit, Millipore Field Service Engineers are located around the world – ready and available to visit your site.
To learn more, contact us today.