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

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 - FRS for Compliance with 21 CFR Part 11
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.