ולידציה - FRS - Regulatory & HMI Requirements

ולידציה – FRS – Regulatory & HMI Requirements

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

ולידציה - URS - Regulatory & HMI Requirements

ולידציה – URS – Regulatory & HMI Requirements

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 and HW/SW Type and Maturity

ולידציה -Testing and HW/SW Type and Maturity

ולידציה -Testing and HW/SW Type and Maturity – GAMP

Process automation systems generally comprise several elements. Categorizing these elements according to those described in GAMP 4 can assist in targeting testing and validation effort.

ולידציה - GAMP - Test Example - part 3Good Automated Manufacturing Practice (GAMP) - Test ExampleGood Automated Manufacturing Practice (GAMP) - Test Example

ולידציה – GAMP – Test Example – part 3

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

ולידציה - GAMP - Test Example - part 3Good Automated Manufacturing Practice (GAMP) - Test ExampleGood Automated Manufacturing Practice (GAMP) - Test Example