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

GAMP - Management of Test Incidents Exceptions

Management of Test Incidents Exceptions

Development life cycle of a system of product containing SW often involves unexpected incidents, predominantly in the testing phase. Whilst defects and failures are unlikely to ever be totally eliminated, occurring incidents should be promptly and correctly dealt with by the test team to minimize the likelihood of passage of avoidable defects intoproduction environment

אילן שעיה - ולידציה - URS Contents

ולידציה – GAMP – Definition of Terms

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 terms used within pharmaceutical and other life sciences (consistent with those used in GAMP 4), Information Technology (IT) industries, and control and automation industries, in order to facilitate understanding testing[…]

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