Microbial process validation contributes significantly to ensuring that a food process or is capable of effectively mitigating a microbial hazard. The ability of a process to inactivate a target ...

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 ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official ...

Continued process verification for a cleaning validation program begins once the validation study is complete. Continued process verification (CPV) for a cleaning validation (CV) program begins once ...

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms. The AFI ...

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 ...