The third part of our Validation case study includes Documentation for IQ and OQ – to be checked at PDI/FAT, DQ Protocols Including PC/PLC, IQ Protocols Including PC/PLC, OQ Protocols Including PC/PLC, PQ Protocols Including PC/PLC
ולידציה – URS – מייצג את דרישות המשתמש, המאמר מפרט מה הן כוללות ומה יש לפרט עבור ביצוע הליך ולידציה
This is how to create the generic PLC model
Functional Requirements Specification -FRS Regarding Requirements for Compliance with 21 CFR Part 11
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)
This article cover the first part of our Good Automated Manufacturing Practice (GAMP) test example.
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
HVAC and AHU control systems. How do they work, theory and examples.
המאמר מסקר שתי מערכות בקרה תעשייתיות מובילות SCADA ו – DCS וההבדל בשימוש בכל אחת מהן .
