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 ...
In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...
• Analytical method validation quality standards, touching on MCERTS and ISO 17025 as examples, leading in to an introduction to method accreditation Various case studies are used throughout the ...