אילן שעיה ilan Shaya

Test Incidents – Analysis, Logging & Classification

Test Incidents- It is important to fully record the details of all new test incidents and maintain an index of these incidents, this
article shows you how to analyse, log and classify test Incidents according to GAMP

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 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[…]