Data integrity is key to the success of any cell therapy program. CDMOs can implement robust data management systems for ...

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...

MasterControl, a leading provider of quality, manufacturing, and asset management software solutions for regulated industries ...

Whether you're making cookies or computers, your product should provide consistent high quality to your customers. The term "quality assurance" describes all the processes and procedures involved in ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

As part of the United States Food and Drug Administration's (FDA's) Critical Path Initiative to medical product development (http://www.fda.gov/oc/initiatives ...

In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...

Achieving this level of reliability requires more than just heavy machinery; it demands a scientific approach to polymer chemistry and a disciplined manufacturing process. The Foundation of Batch ...

Adam Hayes, Ph.D., CFA, is a financial writer with 15+ years Wall Street experience as a derivatives trader. Besides his extensive derivative trading expertise, Adam is an expert in economics and ...

A recent change in outlook at the U.S. Food and Drug Administration (FDA) — the government body that regulates the use of devices and substances in medical care — has escalated the already rigorous ...

Investopedia contributors come from a range of backgrounds, and over 25 years there have been thousands of expert writers and editors who have contributed. Robert Kelly is managing director of XTS ...