Products for the pharmaceutical and medical technology industries are not only subject to extremely high quality requirements, but they must also satisfy laws and industry-specific regulations based on their intrinsic nature. Such laws and regulations are documented within FDA 21 CFR, GMP, for example.
The production processes of these industries are extremely diverse and include technologies that are applied in other industry sectors as well. However, there is one thing that all companies that manufacture pharmaceutical or medical technology products have in common: No matter what, they must ensure that the only products that leave the plant are absolutely flawless. With an IT-based support of the manufacturing process and the complete documentation thereof, including traceability as a result, any use of improper or defective materials can already be ruled out early during production.
The functions of the Manufacturing Execution System (MES) HYDRA integrate the GAMP 5 requirements. They are a valuable aid for manufacturing companies during validation. We have successfully assisted various HYDRA users with validation processes.