To qualify and validate a pharmaceutical manufacturing facility, one must carefully review the facility design for compliance with good manufacturing practices and manage project scope definition, ...

The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

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 ...

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 ...

A Cairns company behind much of the city’s most recognisable architecture has been awarded a contract for a major stage in the Barlow Park upgrade project. Queensland’s Department of Public Works has ...

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 ...

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 ...