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Computer Sytems Validation

Computer Sytems Validation

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Published by iabureid7460
Approach to be followed for computer system validation in regulated industry (pharmaceutical)
Approach to be followed for computer system validation in regulated industry (pharmaceutical)

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Published by: iabureid7460 on Oct 11, 2008
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05/28/2013

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Computer System ValidationGuide
 
Introduction to the Computer SystemValidation
T
his guide was developed as a resource document to assist regulated industryValidation, Quality Assurance, Technical Services, and regulated industry professionals to identify and adapt "best practices" in their management of validationand qualification of computer systems, software, hardware and developmental practices and activities.This guide was developed to be a concise, step-by-step set of management aids, whichare consistent with industry standards. They are designed to guide implementation tothe minimum recommended level of practices and standards. Local management, atits discretion, may decide that these recommended levels are insufficient for localconditions and needs and therefore require more stringent practices and controls.The practices within the guides, when fully implemented will serve to ensure secureand cost effective operation and evolution of protocol implementation.Suggestions for improvement to this guide are always welcome. This document isintended to be living document and will be upgraded and adapted as ‘better practices’emerges.Email All CommentsJohn F Cuspilich, Senior Editor, GMP Publications, Inc.Senior Consultant, FDA.COM 
Introduction
This introduction provides an overview of the Computer SystemValidation Corporate Computer System Validation (CSV) Guide.
ProcessValidation
In 1987 the Food and Drug Administration published a documententitled
 FDA Guidelines
 
on
 
General 
 
 Principles
 
of 
 
 Process
 
Validation’.
It states the following:
 Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined  specifications and quality attributes.
 
Note:
This definition indicates that validation can apply to any process including process managed/controlled by computer systems.
 2
 
Validation
Validation is applied to many aspects of the healthcare and other regulatedindustries and businesses.
Examples include: 
services equipment computer systems processes cleaning
In each case, the objective of validation is to produce documentedevidence, which provides a high degree of assurance that all partsof the facility will consistently work correctly when brought intouse.
Note:
Validation requires documented evidence, if the validation process is not documented then it cannot be proved to haveoccurred.
Scope
This guide looks at computer systems validation only. Computer systems validation includes validation of both new and existingcomputer systems.
 
Definition of computersystem
For the purposes of this guide, a computer system is defined as:
any programmable device including its software, hardware, peripherals, procedures, users, interconnections and inputs for theelectronic processing and output of information used for reporting or control.
 
Examples of computersystems
Examples of computer systems include:
· automated manufacturing equipment· control systems· automated laboratory equipment· laboratory data capture system· manufacturing execution systems· computers running laboratory, clinical or manufacturing database systems
 
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