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
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
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
The third part of our Validation case study includes Documentation for IQ and OQ – to be checked at PDI/FAT, DQ Protocols Including PC/PLC, IQ Protocols Including PC/PLC, OQ Protocols Including PC/PLC, PQ Protocols Including PC/PLC
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
This is the first part of Validation Requirements – case study, it covers Document Contents & Responsibility
ולידציה – Function Design Specification- FDSPreparation Overview
ולידציה – URS – מייצג את דרישות המשתמש, המאמר מפרט מה הן כוללות ומה יש לפרט עבור ביצוע הליך ולידציה
This is how to create the generic PLC model
Functional Requirements Specification -FRS Regarding Requirements for Compliance with 21 CFR Part 11
ולידציה – Testing Process Automation Systems – Testing Responsibilities Supplier and User
ולידציה -Testing and HW/SW Type and Maturity – GAMPProcess automation systems generally comprise several elements. Categorizing these elements according to those described in GAMP 4 can assist in targeting testing and validation effort.
