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What is validation?

Much of the equipment we use today relies on sophisticated technology to work. DVD players, satellite television decoders and mobile phones all process and interpret our actions using software and built in computing power.

Whenever we use these, we expect them to function correctly and in a predictable manner. Pick up the phone, dial a number and we take it for granted that it will ring the person we want. Play a DVD and we assume our player will faithfully and accurately reproduce the encoded pictures and sound for us each time, every time. Our expectation of these devices is only possible because domestic equipment undergoes extensive development and testing and is used by millions of people.

Similarly, in the work environment, packing lines, laboratory analytical instruments and production control systems all have some form of control system. But how can we automatically expect this type of equipment to function correctly, and in a predictable manner?

Whether it depends for its operation on a custom-designed chip, desktop computer, programmable logic controller, networked server or an antiquated mainframe computer, it is a ‘computerised’ system and the process we can go through to maximise the chances of our system functioning correctly, and in a predictable manner, is known as validation.

More formally, the US Food and Drug Administration (FDA) defines validation as:

“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”

(Source: FDA Guidelines on General Principles of Process Validation, 1987)


What is involved in Computer System Validation (CSV)?

The Services section describes this in more detail so, in general terms, to ensure you have a quality computerised system you need to Specify it, Test it and Prove it.

To Specify it when it is a new system to be purchased from a vendor for example, you will need a User Requirements Specification (URS). This document forces you and your future users to consider and agree what it is you expect the system to do. A URS contains a wish list of what you want in standard English, rather than how it can be achieved in technological terms.

After the URS has been agreed (approved), you need a Functional Specification (FS). This is the vendor’s response to your URS, telling you what they are going to provide (in technical terms). It might not necessarily match all your requirements in your URS, but it should be comprehensive enough for you to know precisely what you will be receiving. Whilst the details of the FS will be dictated by the type of system, it should include information relating to system performance and security, data access and capacity and any interfaces to other systems etc.

Having agreed precisely what the system is going to comprise, you now need to ensure it will deliver on all its promises. You need to Test it.

Hardware testing demonstrates you have the correct pieces of kit and that these match the specifications your vendor has stated in the FS. Software testing helps to show not only that the system works as described in the FS, but also that it handles errors in a predictable way and is not liable to crash or mysteriously hang. In other words, that the system is fit for normal usage, and - when challenged - can cope with non-routine or inappropriate usage.

Specifications and test scripts help to show you are serious about making sure your system is compliant. They demonstrate you know what the system is designed to do, and have thought about how to test that it behaves acceptably under all the conditions it might conceivably meet.

However, you need to Prove it and the ultimate proof your system operates correctly are written test results, observed by an independent witness. These will demonstrate you have followed the test scripts properly and will provide detailed evidence of your testing to external agencies and inspectors, both now and in the future. They will show what you did to the system, how it responded and your conclusions as to whether the responses were acceptable or not.

To the uninitiated, computer validation can often seem complicated and mysterious. However, with over a decade of experience it is a process we know extremely well!


To see how we can help your company refer to Services.

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