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, ...

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

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 ...

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

On January 30, 2023, CMS posted for inspection a final rule describing its Risk Adjustment Data Validation audit methodology (the Final RADV Rule). As we have discussed in prior alerts, 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.

However, effectively assessing their validation technique proved to be a challenge. "We are not evaluating a method, instead we are evaluating an evaluation. So, we had to step back, think carefully, ...

The Workshop is planned to highlight, review, and discuss issues related to the implementation of XRF methodologies, including addressing recommendations for compliance to technical requirements of ...

If chip design had a face, it would have a wrinkle or two, an especially deep one caused by the increasingly complex challenge of hardware and software verification. Until recently, these two elements ...