20 Feb 2013

2013 Trend: Smarter Computer Validation

by Fran Nolan

Having been around when dinosaurs roamed the earth and computer validation was “invented,” I am sorry to say that things haven’t changed that much across the industry. Validation of computer systems was originally expected by regulators and subsequently introduced in the manufacturing (cGMP) and lab systems (GLP) arenas. Clinical departments were loath to adopt validation requirements and, to this day, still seem reluctant to accept these requirements.

Over the years, the “validation community” (QA, IT, business functions, etc.) has been very well intended, with many members attempting to promote the ideas that good software development life cycle (SDLC) practices—including documented testing—made good business sense and we shouldn’t look at computer validation as simply a regulatory requirement. Unfortunately, the validation community as a whole generally failed to get this message across; and to this day, many companies, including many software development organizations within those companies, see validation as a necessary evil to be avoided or minimized at all costs.

Those companies, such as Medidata, who have adopted a more enlightened approach to validation have reaped the benefits of more effective and efficient software development practices and most importantly, higher quality software solutions. In particular, great success has been seen in incorporating validation principles within the SDLC process itself, rather than treating validation as a separate exercise. In addition, more modern development and testing practices, such as those based on the agile methodology, result in higher quality solutions, while still generating the necessary documentation expected by regulators.

In 2013, I see even more companies adopting this smarter approach to computer validation and reaping the benefits of a more effective and efficient validation practice.

More on Fran Nolan

Related posts

Computer System Validation: Let’s Green Light More Effectively

The time has come for the industry to take a ...

Congratulations to our own DIA Service Award Winner – Fran Nolan

One of the best parts of my job is seeing ...

Predicting the Future of Clinical Site Monitoring: Will We Move Towards a Risk-Based Approach?

Medidata and INC Research co-hosted two seminars in California last ...

Reduce Site Monitoring Costs with a Risk-Based Approach

Following a joint seminar with Medidata Services Partner INC Research, ...


Comments in this post

  • Nick Hargaden
    1 year ago

    HI Fran

    I agree that we would all be better off if we can stop seeing validation or SQA as an “FDA thing”, or a “GAMP thing” and challenge ourselves to be the experts in our fields. In fact we should apply that idea to all our activities!

    I’d be interested to hear more on how you are incorporating validation principles within the life cycle. I would also be interested hear how you have found external parties have received agile approaches. My experience is that it still creates some concern and confusion.


Leave a reply


TransCelerate and Medidata Explore ...

It’s no secret that clinical tria ...

Investigative Sites Crave Metrics ...

http://youtu.be/g5jUgcT5N6Q The ...


What happens in Vegas, stays in Veg ...

The ABC’s of Risk-Based Monitoring

http://youtu.be/p_8bVA4YwUQ Medi ...

EDC and ePRO Come Together at SCDM

http://youtu.be/nWJybTdHDWU I’ ...

Joe on Mobile Patient Data Capture — A Huge Step Forward
Nailed it.

john anstey on Ni Hao from Shanghai! 上海的你好
Great article. Exciting times ahead. I believe that China will award us the rare opportunity of applying our platform as...

Kajol on Data Management, Safety Systems and How Technology Can Improve Clinical Development Processes
It is a nice blog. It contain good information on clinical data management

Laurie Meehan on Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
Agreed - a new term would have been preferable, but we of course have the benefit of hindsight. We’re...

Steve Young on Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
Thanks Laurie for your thoughts. I agree with your concern regarding the "re-definition" of SDV by TransCelerate - particularly...