ולידציה – GAMP – Definition of Terms
30/09/2015
Good Automated Manufacturing Practice (GAMP) Definition of Terms Definition of Terms Used in Testing Environments This document provides a definition of a set of testing
Good Automated Manufacturing Practice (GAMP) Definition of Terms Definition of Terms Used in Testing Environments This document provides a definition of a set of testing
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
This is the first part of Validation Requirements – case study, it covers Document Contents & Responsibility
FRS – Regulatory Requirementscover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demandsHMI Requirementsare intended to provide the URS demands from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer’s contract with the supplier
URS – Regulatory & HMI Requirements cover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demands HMI Requirementscover the provisions demanded from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer’s contract with the supplie
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)
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 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
