What is validation & gamp category 5

Question

Accepted Answer

Validation is the process of ensuring that a system or process meets predetermined requirements. GAMP Category 5 refers to software applications that are configurable and require minimal customization.

Validation is the process of confirming that a system or process meets predefined specifications and quality standards.
GAMP (Good Automated Manufacturing Practice) is a set of guidelines for the validation of automated systems in the pharmaceutical and healthcare industries.
GAMP Category 5 refers to software applications that are commercially available, configurable, and require minimal customization.
These applications are typically validated by the end-user through a risk-based approach, focusing on critical functionalities and potential impact on patient safety and product quality.
Examples of GAMP Category 5 software include commercial off-the-shelf (COTS) applications used in pharmaceutical manufacturing, laboratory information management systems (LIMS), and electronic document management systems (EDMS).

Accepted Answer

the act of confirming something as true or correct: The new method is very promising but requires validation through further testing.GAMP® 5 aims to provide a comprehensive explanation of how pharmaceutical companies should validate their computer systems. In practice, this means that these recommendations apply both to the users of automated pharmaceutical products, as well as the manufacturers who create and market them.

What is validation &amp; gamp category 5

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What is validation & gamp category 5