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ולידציה – Operation Qualification – OQ- part 1

The Operation Qualification (OQ) protocol is part of the validation documentation that covers the verification of the proper operation of the system under validation in the user’s facility. This OQ protocol is generic, and the system may include a PC with Human/Machine Interface (HMI), a Programmable Logic Controller* (PLC), pressure, temperature and humidity transmitters, and other monitoring and control components designed to maintain the user’s facility in proper environmental conditions (temperature, pressure and humidity)

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ולידציה – GAMP – Test Example – part 3

This article cover the third part of our Good Automated Manufacturing Practice (GAMP) test example. This part will cover the typical test phases for Factory Acceptance Test – FAT, Site Acceptance Test – SAT / Installation Qualification – IQ, Operation Qualification – OQand Performance Qualification – PQ

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ולידציה – GAMP-Test Execution

GAMP-Test Execution. After a test is written, reviewed, perhaps rewritten, and finally approved, it is then ready for execution.Before commencing tests using individual Test Cases or Test Scripts, pre-requisites for the test phase should first be verified and recorded

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