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

Customer satisfaction determines customer loyalty, customer purchase intentions and in turn, a company's revenue stream. Product quality improves customer satisfaction. Reducing variation in both key ...

The manufacturing process is a complex one that can be impacted by many factors: supplies, equipment, factory overhead, the need for special parts, and the people who work at all points in the process ...

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.

An important aspect of Quality by Design (QbD) is to establish meaningful and realistic specifications. Well-defined specifications control the performance of products, as they derive from ...

The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution. All measurements are ...

Voestalpine Additive Manufacturing has earned certification to American Petroleum Institute’s Specification 20S, qualifying ...