This article provide overviews of the main test procedures and verification, and their purposes. This OQ procedure is generic, and relevance of the test procedures and verifications provided below depends on the composition of the system under validation
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 – Testing Process Automation Systems – Testing Responsibilities Supplier and User
ולידציה -Testing and HW/SW Type and Maturity – GAMPProcess automation systems generally comprise several elements. Categorizing these elements according to those described in GAMP 4 can assist in targeting testing and validation effort.
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
This article cover the second part of our Good Automated Manufacturing Practice (GAMP) test example. This part will cover the typical test phases for supplier’s application SW Module Testing, supplier’s Module Integration Testing and the supplier’s Integration Testing (cont’d) .
This article cover the first part of our Good Automated Manufacturing Practice (GAMP) test example.
Installation Qualification (IQ) Protocol – Test Procedures. This article describes the test procedures for the installation of purchased software (SW) and application SW
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
מהי ספציפקציה פונקציונאלית וכיצד היא צורה שבה הספציפיקציה הפונקציונלית משתלבת בתהליך הפיתוח
ולידציה- GAMP – Test Environments – Test Data Sets
ולידציה – GAMP – Hardware & Software Test Environments.HW can be categorized according to both GAMP 4 HW category (standard or custom) and its function within the test environment.. Test SW can also be categorized according to both GAMP 4 SW category and its function within the test environment
