ולידציה – URS Contents
26/07/2015
ולידציה – URS – מייצג את דרישות המשתמש, המאמר מפרט מה הן כוללות ומה יש לפרט עבור ביצוע הליך ולידציה
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
Installation Qualification (IQ) Protocol – Test Procedures. This article describes the test procedures for the installation of purchased software (SW) and application SW
ולידציה – Installation Qualification (IQ) Protocol – The Installation Qualification (IQ) protocol is part of the validation documentation that covers the verification of the proper installation and operation of the system under validation in the user’s facility
The Design Specification -DS is part of the validation documentation that provides information necessary to complete the design of the project. This document covers only the DCS side and integration with ELT-GHS-150-T3 Gas Heater skid.
