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 ...
The first part of this article discussed general strategies for validation extensions to other test method components, laboratories and even different test methods.1 This second part provides ...
Firms can use practical tools and criteria to implement advanced analytical test methods for biopharmaceuticals. They an also extend and maintain the validation status for a licensed test method from ...
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