אוטומציה ובקרה - Create the Generic PLC Model
ולידציה - FRS for Compliance with 21 CFR Part 11
ולידציה – Operation Qualification – OQ- part 2

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)

ולידציה - GAMP - Test Example - part 3Good Automated Manufacturing Practice (GAMP) - Test ExampleGood Automated Manufacturing Practice (GAMP) - Test Example
ולידציה - Installation Qualification (IQ) Protocol - 2

ולידציה – Installation Qualification (IQ) Protocol

ולידציה – Installation Qualification (IQ) Protocol – The Installation Qualification (IQ) protocol is part of the validation documentation that covers the verification of the proper installation and operation of the system under validation in the user’s facility