Introduction to the Computer System Validation

This guide was developed as a resource document to assist regulated industry Validation, Quality Assurance, Technical Services, and regulated industry professionals to identify and adapt "best practices" in their management of validation and 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, which are consistent with industry standards. They are designed to guide implementation to the minimum recommended level of practices and standards. Local management, at its discretion, may decide that these recommended levels are insufficient for local conditions and needs and therefore require more stringent practices and controls.

The practices within the guides, when fully implemented will serve to ensure secure and cost effective operation and evolution of protocol implementation.

Suggestions for improvement to this guide are always welcome. This document is intended to be living document and will be upgraded and adapted as ‘better practices' emerges.  




This introduction provides an overview of the Computer System Validation Corporate Computer System Validation (CSV) Guide.


Process Validation

In 1987 the Food and Drug Administration published a document entitled
FDA GuidelinesonGeneralPrinciplesofProcessValidation'.

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.



Validation is applied to many aspects of the healthcare and other regulated industries and businesses.

Examples include:


services       equipment      computer systems      processes      cleaning

In each case, the objective of validation is to produce documented evidence, which provides a high degree of assurance that all parts of the facility will consistently work correctly when brought into use.

Note: Validation requires documented evidence, if the validation process is not documented then it cannot be proved to have occurred.



This guide looks at computer systems validation only. Computer systems validation includes validation of both new and existing computer systems.


Definition of computer system

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 the electronic processing and output of information used for reporting or control.


Examples of computer systems

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



The purpose of this guide is to help you:

· identify computer systems that require validation

· determine how to validate, and the extent of validation required, for the computer systems that have been identified

· comply with the validation requirements documented in the (CSV) in accordance with your Company's Software Systems Development Master Plan (SDMP). 



This guide is intended for:

· Information Resources, Services and Technology members

· all concerned managers, auditors and regulatory personnel

· all developers of computer systems applications

· all personnel involved in computer systems procurement

· all users of computer systems involved in validation activities



This guide is divided into:

· 11 chapters

· Reference material

Chapter 1 looks at who is responsible for validation activities

Chapter 2 looks at the things you need to do before you perform a system validation

Chapters 3 outlines the validation process

Chapters 4 to 11 take a more detailed look at the validation process

The Reference material consists of a glossary, references and standards.

Note: The Glossary consists of a lexicon of validation terms.


Use of Standard terms

The terms and meanings in the Glossary have been adopted as a standard for use within this guide.

Consistent use of these terms will facilitate communication about computer system validation throughout the Company.


Introduction to CSV Validation Responsibilities Before You Start Validation The Process Establish Teams(s) Determine Activities
Write the Protocol System Development Details Perform Qualification Activities Develop &  Review  Procedures Certify the System Review Periodically