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
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.
