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 ...

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 ...

If new digital capabilities and top-notch data are critical to process efficiency and competitive advantage, it makes no sense to leave validation (proof that they fulfil what’s required) until the ...

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 ...

With data integrity regulatory violations on the rise, there is a need for better and more consistent validation management practices. Unreliable data leads to unreliable validation execution. Quality ...

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 ...