Practical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen. Validation failures, just like out-of-specification (OOS) ...
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 ...
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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