ואילן שעיה Iilan Shaya ולידציה - Validation case study

ולידציה – Validation case study – part 2

The second part of our case study deals with the Validation Requirements of Documentation for Initial Tender,Documentation for Design Review,Documentation Prior to FAT or Pre-Delivery Inspection – PDI& Commissioning

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 - FRS contents

ולידציה – FRS Contents

ולידציה -FRS Contents  This article was written by Iian Shaya, validation,automation and control expert The FRS presents functional requirements for installing and operating a monitoring and control system, in response to and compliance with the user’s requirements For example, the FRS may propose to fulfill the URS requirements using a system that includes a PC[…]

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