{"id":35523,"date":"2015-09-02T06:39:50","date_gmt":"2015-09-02T03:39:50","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35523"},"modified":"2015-09-02T06:39:50","modified_gmt":"2015-09-02T03:39:50","slug":"%d7%95%d7%9c%d7%93%d7%99%d7%a6%d7%99%d7%94-validation-case-study-part-1","status":"publish","type":"post","link":"https:\/\/smartlogic.co.il\/staging_new\/%d7%95%d7%9c%d7%93%d7%99%d7%a6%d7%99%d7%94-validation-case-study-part-1\/","title":{"rendered":"\u05d5\u05dc\u05d3\u05d9\u05e6\u05d9\u05d4 – Validation case study – part 1"},"content":{"rendered":"

\u05d5\u05dc\u05d3\u05d9\u05e6\u05d9\u05d4 -1 Validation Requirements –\u00a0case study- part<\/h2>\n

\u00a0This article was written by Iian Shaya, validation,automation and control expert<\/p>\n

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>), a Programmable Logic Controller (PLC<\/a>), virtual hardware (HW<\/a>), software (SW<\/a>), and other components designed to maintain the user's facility in proper conditions specified by the user.<\/p>\n

Validation Requirements Document Contents<\/h3>\n

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.<\/p>\n

The main chapters and sections of a Validation Requirements document are:<\/p>\n

Responsibility<\/p>\n

Validation Requirements<\/p>\n

Documentation for Initial Tender<\/p>\n

Documentation for Design Review<\/p>\n

Documentation Prior to Factory Acceptance Test (FAT) or Pre-Delivery Inspection –\u00a0PDI<\/p>\n

Commissioning<\/p>\n

Documentation For Installation and Operational Qualification (IQ<\/a> and OQ<\/a>) – to be checked at PDI\/FAT<\/p>\n

Design Qualification (DQ<\/a>) Protocols (Including PC\/PLC<\/a>) Architecture<\/p>\n

<\/a> Installation Qualification (IQ<\/a>) Protocols (Including PC\/PLC<\/a><\/p>\n

<\/a> Operational Qualification (OQ<\/a>) Protocols (Including PC\/PLC<\/a><\/p>\n

Performance Qualification (PQ) Protocols<\/p>\n

<\/a> Computerized System Validation<\/p>\n

Responsibility<\/h3>\n

This section lists the responsibilities of contractor, the user, and the required contents of the documents composing the validation file<\/p>\n

The contractor is responsible for creation and performing the DQ<\/a>, Design Review, Commissioning, IQ <\/a>and OQ<\/a> validation protocols<\/p>\n

The user is responsible for creation and performing the PQ validation protocols<\/p>\n

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<\/a> and BOD documents<\/p>\n

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<\/p>\n

Commissioning Execution (CE) of the system will be documented and checked only by the contractor. This document will check system readiness for \u00a0OQ<\/p>\n

Installation Qualification –IQ<\/a><\/p>\n

IQ will establish documented evidence that the system is installed according to the manufacturers\u2019 specifications and user requirements, and assure that the environment is appropriate for its intended purpose<\/p>\n

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<\/p>\n

Operational Qualification –\u00a0OQ<\/a><\/p>\n

OQ will establish documented evidence that the system is operated according to manufacturers\u2019 specifications and user requirements, and assure that the environment is appropriate for its intended purpose<\/p>\n

OQ will establish documented evidence that the system is operated according to manufacturers\u2019 specifications<\/p>\n

.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<\/p>\n

Performance Qualification-\u00a0PQ<\/p>\n

PQ will establish documented evidence that the system performs according to manufacturers\u2019 specifications and user requirements, and assure that the environment is appropriate for its intended purpose<\/p>\n

The PQ protocols are user's responsibility<\/p>\n

\u00a0This article was written by Iian Shaya, validation,automation and control expert<\/p>\n