Applying DOE and Risk-Assessment Methods Early Eases Process Validation However innovative or compelling a novel manufacturing process may be, its value depends on the ability to validate the process ...

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

CRISPR technology has not yet been FDA approved for Cystic Fibrosis or Muscular Dystrophy and is still being investigated for use against these diseases. Gene editing has enormous potential to address ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...