Computerized System Validation
17/09/2015
Computerized System Validation – the final part in our validation case study
Computerized System Validation – the final part in our validation case study
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
DQ – Design Qualification is for Design Review by verifying that the system has been designed as specified in the URS -User Requirements Specification, FDS – Functional Design Specification, and relevant equipment specifications satisfying all GMP requirements
Functional Requirements Specification -FRS Regarding Requirements for Compliance with 21 CFR Part 11
