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[…]

SSO for Turbine Air Inlet Cooling

ולידציה – SSO for Turbine Air Inlet Cooling

   Schedule of System Operation – SSO Turbine Air Inlet Cooling This article is an elaborated example of a schedule of system operaton – sso we did for one of our clients. Of course the actual documents contain all the operational and alarm parameters                   Scope This Schedule[…]

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[…]