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 -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.

ולידציה - GAMP - Test Example - part 3Good Automated Manufacturing Practice (GAMP) - Test ExampleGood Automated Manufacturing Practice (GAMP) - Test Example

ולידציה – GAMP – Test Example – part 3

This article cover the third part of our Good Automated Manufacturing Practice (GAMP) test example. This part will cover the typical test phases for Factory Acceptance Test – FAT, Site Acceptance Test – SAT / Installation Qualification – IQ, Operation Qualification – OQand Performance Qualification – PQ

ולידציה - GAMP - Test Example - part 3Good Automated Manufacturing Practice (GAMP) - Test ExampleGood Automated Manufacturing Practice (GAMP) - Test Example