Types of validation AMV procedure and Limitations QMS system What's Challenge of QC Procedure of OOT/OOS Analyst Qualification

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The question is related to quality control and validation procedures in a senior executive role.

Types of validation include process validation, method validation, and equipment validation.
AMV (Analytical Method Validation) procedure is used to validate analytical methods used in quality control.
Limitations of AMV include the need for extensive resources and time, and the possibility of false results.
QMS (Quality Management System) is a set of policies, processes, and procedures used to ensure quality control.
The challenge of QC (Quality Control) is to maintain consistent quality standards and identify and resolve any issues or deviations.
OOT (Out of Trend) and OOS (Out of Specification) refer to situations where test results fall outside the expected range.
The procedure for OOT/OOS involves investigating the root cause, performing retesting if necessary, and documenting the findings.
Analyst qualification refers to the process of assessing and ensuring the competency and skills of analysts performing quality control tests.

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