A Validation Survival Guide for the New Millennium

A positive attitude is essential to beating the validation blues This does not mean, however, that managers and practitioners will not come across problems when validating computer systems. In such situations, it is often useful to focus on why validation is needed and reflect on the following advice  

Do not assume validation has an intrinsic value—it has none. But your core product or service does. Can you quantify the benefits of validation for your business  

Aim to build the principles of validation into the culture of your organization. It was never intended to be a separate function. 

Mold the principles of validation to suit your own working practices. It is often more cost-effective to use the services of an outside consultant than your own in-house staff. 

Err on the side of caution when estimating the cost of validation. During projects, do not be complacent challenge any overspending or project slippage. Resist making changes to project requirements that are not really necessary, as these could considerably increase costs. 

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