Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

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 year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. A year’s worth of FDA warning letters suggest ...

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015. To ensure that biotech manufacturing processes can consistently deliver high quality ...

The integration of advanced microprocessors and sophisticated software has transformed these instruments. Modern magmeters ...

Each year, the Central Processing System (CPS) will randomly select a portion of all aid applications for the verification process. The selection process is controlled by the Federal Government and is ...