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 - URS - Regulatory & HMI Requirements

ולידציה – URS – Regulatory & HMI Requirements

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 – Operation Qualification – OQ- part 2

ולידציה – Operation Qualification – OQ- part 2

This article provide overviews of the main test procedures and verification, and their purposes. This OQ procedure is generic, and relevance of the test procedures and verifications provided below depends on the composition of the system under validation