Implementing a systematic and structured approach ensures that the validation process is consistent, traceable, and compliant with regulatory requirements. This means that validation activities should be planned, executed, and documented throughout the entire system’s lifecycle, from concept and development to retirement. Lifecycle Approach within QMS: The second principle advocates for the adoption of a lifecycle approach to computer system validation within the Quality Management System (QMS) of an organization.By gaining a deep insight into the product’s intended use, critical quality attributes, and associated manufacturing or operational processes, organizations can make informed decisions regarding system design, qualification, and validation. ![]() This understanding is crucial for effectively validating computer systems that are integral to these products and processes.
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