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, ...

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

Generative AI in medtech raises questions on safety, validation, and regulatory challenges, explored in MD&M West's "GenMLP" ...

Introduction: Why Data Quality Is Harder Than Ever Data quality has always been important, but in today’s world of ...

The semiconductor industry is at an inflection point. The convergence of advanced multi-die architectures, AI-driven workloads, and rapidly evolving interface protocols is creating unprecedented ...

Cryopreservation Freezer Market Size The global Cryopreservation Freezer Market was valued at USD 568 Million in the year 2024 and ...

An important aspect in software engineering is the ability to distinguish between premature, unnecessary, and necessary ...

The Oura Ring isn’t FDA approved as a medical device. It’s considered a general wellness product. This means it’s designed ...

Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

Manufacturing SOP creation is breaking down as critical process knowledge remains trapped in training videos and ...

Purpose-built electronic quality management systems are a better fit for CGT production than traditional technologies.