This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms ...

Trinity Solutions and Services provides asset management, maintenance, validation, and technical staffing services for regulated industries. With a focus on execution, lifecycle alignment, and ...

In highly regulated industries, quality and validation procedures can be make or break, and getting them right requires working with system integrators who have industry-specific experience. My first ...

Despite their frequent interchangeable use, understanding the distinction between validation and qualification is critical in pharmaceutical environments. Validation is a broader concept encompassing ...

How has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future? General guidelines regarding ...

The course provides an overview of the concept of qualification and validation as described in Annex 15 to Eudralex Volume 4. It covers responsibilities and terminology (qualification, validation and ...

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 ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...