SMART quality & compliance
How is a system validated?
Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and vocabulary. A Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. Validation: Confirmation, through the provision of objective evidence, that the specified requirements for a specific intended use or application have been fulfilled. Qualification: Process to demonstrate the ability to fulfill specified requirements In general : Validation: For systems or general topics: process, systems, etc. Qualification: For single or individual items within your system, process: Equipment, lab methods, etc Below is a simplified process diagram on how to validate a system…
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