D/3 and FlexBatch® Application in 21 CFR Part 11 and GAMP 5 Compliant Application in France

PUBLISHED ON Nov 20, 2009

NovaTech Automation recently sold the first-ever D/3 and FlexBatch system in France, winning the project over a competing HMI / PLC solution.  The production facility and the control system design and implementation must be in compliance with both the 21 CFR Part 11 and GAMP 5 standards.

To simplify the compliance and validation effort, NovaTech Automation has modified the D/3 and FlexBatch products.  These modifications will be incorporated into NovaTech Automation’s standard product offering so our entire customer base will be able to benefit from the new features such as Windows® authentication, detailed logging information, automatic generation of Master Recipe Versions when an existing Master Recipe is edited, etc.

The new line, scheduled to begin trial runs in September and make marketable product by the end of 2009, will produce intravenous bags containing parenteral nutrition supplements.  Since the new production will manufacture active ingredients intended for the U.S. pharmaceutical industry, it must be able to be validated by the FDA.

NovaTech Automation will provide an ongoing consulting role throughout the project life-cycle, helping to not only implement our products, but to help define clear requirements for several aspects of the project, including: project organization, responsibilities of the various team members, validation strategy, design/implementation methodology, and documentation.

This project is noteworthy for NovaTech Automation as it will be the first installation of the D/3 and/or FlexBatch in France, as well as the first D/3 pharmaceutical application in Europe.