SSO for Turbine Air Inlet Cooling

ולידציה – SSO for Turbine Air Inlet Cooling

   Schedule of System Operation – SSO Turbine Air Inlet Cooling This article is an elaborated example of a schedule of system operaton – sso we did for one of our clients. Of course the actual documents contain all the operational and alarm parameters                   Scope This Schedule[…]

ולידציה - FRS - Regulatory & HMI Requirements

ולידציה – FRS – Regulatory & HMI Requirements

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

ולידציה – FRS Contents

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 and control system, in response to and compliance with the user’s requirements For example, the FRS may propose to fulfill the URS requirements using a system that includes a PC[…]

ולידציה - FRS for Compliance with 21 CFR Part 11