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
Schedule of System Operation – SSO Turbine Air Inlet Cooling This article is an elaborated example of a schedule of system operaton – sso we
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
The Function Design Specification (FDS) is part of the validation documentation. In this article I will continue to elaborate the parts of the FSD of system function and the system facilities
ולידציה – Function Design Specification- FDSPreparation Overview
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 This article was written by Iian Shaya, validation,automation and control expert The FRS presents functional requirements for installing and operating a monitoring
URS – Regulatory & HMI Requirements cover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demands HMI Requirementscover the provisions demanded from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer’s contract with the supplie
ולידציה – URS – מייצג את דרישות המשתמש, המאמר מפרט מה הן כוללות ומה יש לפרט עבור ביצוע הליך ולידציה
User Requirements Specification (URS) and Functional Requirements Specification (FRS) -Introduction
