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 ...

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 ...

Design of experiments enables engineers to demonstrate or understand a process while providing information required for achieving regulatory compliance. A valuable method for predicting process ...

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 ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...

T he new AI-automated tool ensures that critical paperwork — from C ertificates of O rigin to Bill s of Lading — is accurately validated within seconds rather than days, streamlining operations and ...