INTEGRATION | LABORATORY INFORMATICS GUIDE 2015
capture, the intellectual property capture, and the actual process development concept that goes all the way through, and connects all these departments up.’
THE PAPERLESS LAB AND QUALITY BY DESIGN Two concepts permeate this drive to integration: one is the paperless laboratory and the other is Quality by Design. According to Shah, the concept of
paperless lab has been enthusiastically adopted by the pharmaceutical industry in Europe. But, he warned: ‘The reality is that paperless lab is not one thing or one solution; it is really a goal that the organisation has to try to achieve.’ In many ways, he continued, paper is just a stand- in for a manual process: ‘In other words, if paper is involved, then a human being is involved. Then the chances of errors creep in. Removing paper is really removing the human being from that process step, and improving the quality and velocity of your data.’ For Denny-Gouldson, attention to process
is critical also: knowing what pieces of data have to be transferred is one element, but the second one is understanding and
re-engineering the process by which that data moves. ‘In so many cases, we have seen paper systems being used to drive these environments and there is no knowledge of what is going on. We have been able to map those processes and the data requirements into a holistic environment.’ It’s not just paper: ‘Excel is a data
graveyard,’ he remarked. But the point of integrating the analytics and having a real-time reporting of the analyses is that
Two concepts permeate this drive to integration: one is the
paperless laboratory and the other is Quality by Design
it allows the production plant to ‘build up a knowledge base: one of the questions in biologics is “do we understand our process to the point that, when we see a deviation – e.g. the temperature goes too high – do we know what that’s going to do downstream?” They can apply their process knowledge more effectively to get quality by design – you design in the quality because you know so much about the system you are running.
Once in place, our system allows people to optimise their process much more easily than in a paper or Excel-based workflow.’ But such a re-design does not mean
that a regulated workflow would be done in a different way and then have to be revalidated. According to Trish Meek, director of product strategy for the informatics division of Thermo Fisher, all companies want to preserve, as much as possible, the investments they have made in their existing technologies. The points at which the different elements of the process are connected together will be dependent on software systems already in place as well as the process itself. ‘Our tools are flexible – people can tailor to make the appropriate connection points for their process. You’re not looking at a one-size-fits-all system,’ she said. She stressed: ‘It is not realistic to say “you
need to throw out this or that system”. You have to look at the tools you have already implemented and invested in, and how do you get the best out of them. What is the process today, and how can we optimise it given those systems and constraints?’ The business value lies in making those
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