ולדיציה - Validation case study - part 1
This is the first part of Validation Requirements - case study, it covers Document Contents & Responsibility
פורסם:
ולדיציה -1 Validation Requirements - case study- part This article was written by Iian Shaya, validation,automation and control expert Validation Requirements is a document which may be part of the validation documentation that describes the validation strategy for a system or subsystem. This document is generic; the system or subsystem may include a PC with Human/Machine Interface ( HMI ), a Programmable Logic Controller ( PLC ), virtual hardware ( HW ), software ( SW ), and other components designed to maintain the user's facility in proper conditions specified by the user. Validation Requirements Document Contents This document is structured in a relatively standard fashion, with predetermined chapters and sections, where the final contents are tailored according to the type and size of the system under validation. The main chapters and sections of a Validation Requirements document are: Responsibility Validation Requirements Documentation for Initial Tender Documentation for Design Review Documentation Prior to Factory Acceptance Test (FAT) or Pre-Delivery Inspection - PDI Commissioning Documentation For Installation and Operational Qualification ( IQ and OQ ) - to be checked at PDI/FAT Design Qualification ( DQ ) Protocols (Including PC/ PLC ) Architecture Installation Qualification ( IQ ) Protocols (Including PC /PLC Operational Qualification ( OQ ) Protocols (Including PC/ PLC Performance Qualification (PQ) Protocols Computerized System Validation Responsibility This section lists the responsibilities of contractor, the user, and the required contents of the documents composing the validation file The contractor is responsible for creation and performing the DQ , Design Review, Commissioning, IQ and OQ validation protocols The user is responsible for creation and performing the PQ validation protocols Design Qualification (DQ) - The design of the system will be documented and checked in the Design Specification. This specification will include details of the system and must be traceable to the URS and BOD documents Mechanical Completion Check Report (MCCR) of the system will be documented and checked only by the contractor. This document will check system readiness for the IQ Commissioning Execution (CE) of the system will be documented and checked only by the contractor. This document will check system readiness for OQ Installation Qualification - IQ IQ will establish documented evidence that the system is installed according to the manufacturers’ specifications and user requirements, and assure that the environment is appropriate for its intended purpose Each IQ protocol will include an appendix of deviation report, which describes the deviations (if they existent) of the specific system, and the contractor will be responsible to correct them Operational Qualification - OQ OQ will establish documented evidence that the system is operated according to manufacturers’ specifications and user requirements, and assure that the environment is appropriate for its intended purpose OQ will establish documented evidence that the system is operated according to manufacturers’ specifications .Each OQ protocol will include an appendix of deviation report, which describes the deviations (if they existent) of the specific system, and the contractor will be responsible to correct them Performance Qualification- PQ PQ will establish documented evidence that the system performs according to manufacturers’ specifications and user requirements, and assure that the environment is appropriate for its intended purpose The PQ protocols are user's responsibility This article was written by Iian Shaya, validation,automation and control expert