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