Computer System Validation – Business as Usual?

A colleague asked me earlier today what were the big issues at the moment in computer system validation – and I couldn’t really think of any.


After more than twenty years introducing computer system validation to a lot of companies, consulting on Part 11, getting ready for Y2K, responding to Part 11, addressing infrastructure qualification and adopting a risk-based approach to validation the question is very much ‘where next?’.

To some extent it depends on what happens with risk-based validation. As the results from our webcast polls show, many Life Sciences organisations are still struggling to adopt a justifiable risk-based and cost effective approach to computer system validation.

At the moment it does appear to be business as usual – we still see computer system validation issues cited in FDA Warning Letters (and anecdotally reported by other regulatory agencies) but its justified and at a reasonable level in comparison to other more pressing topics – very much what we were used to around a decade ago.

However, if companies continue to use taking a risk-based approach as an excuse for simply doing less – rather than providing a real risk-based rationale for shifting resources to areas of the greatest risk – things may change. Some regulatory agencies have already commented that they are getting wise to ‘risk-based’ equating to ‘simply doing less’ and companies simply adopting GAMP® 5 as a flag of convenience for reducing spending on computer system validation without any clear rationale for doing less. Some inspectors have warned that they will take enforcement actions unless there is a clear and sound risk-based rationale for reducing the level of validation. Efficiency savings are fine, but only when the same goals are met.

There is then a possibility that we could see an increase in enforcement actions in response to Life Sciences companies taking the cost savings too far, but hopefully common sense will prevail as more individuals and organisations really start understand how to achieve the same objectives with less time and effort.

That leaves us with the other ‘big issue’ – which is how the industry is looking to changes in IT - such as cloud computing, virtualization, outsourcing and the like – and wondering how to apply risk-based principles to new technology and different business models.

While many Life Sciences companies are still relatively slow to change others are quietly moving ahead and the immediate future is probably one of evolution and not revolution. That’s not to say however that such evolution isn’t exciting – there is great potential to leverage newer technologies and models to deliver enhanced business performance, reduce costs and help restore the bottom line. If we can seize these opportunities and also address the compliance and validation issues in a cost effective manner then we’re in for a very interesting time – even if it’s not quite as exciting as when the regulators were giving everyone a hard time.