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, ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

Continuous compliance: Rather than preparing for audits, agents continuously monitor validation completeness, test coverage, ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...

With the ever-increasing pace of biological research, there is a plethora of headlines describing novel and fascinating discoveries about our natural world. What’s easy to overlook, however, is the ...

Months after announcing a new program to validate self-reported nursing home quality data, the Centers for Medicare & Medicaid Services has begun notifying providers of their selection.

For January’s Method of the Month I have selected the method presented by Kezzia S. Jones and colleagues in their recent reports article. The method utilizes binding to a surrogate protein (named ...