IT organisations in the life sciences are under pressure to cut costs while adapting to emerging technologies, supporting new business models, developing new skills, and dealing with an explosion in data. This is quite a task as there are also GxP requirements to consider. Torben Thorhauge, vice-president of NNIT and responsible for life sciences infrastructure outsourcing, explains how the GxP cloud is part of the solution.
"Traditionally, many life science businesses have handled infrastructure by themselves," says Torben Thorhauge, vice-president of IT advisory, development and outsourcing company NNIT. "In comparison with other industries, life sciences have been conservative when it comes to IT outsourcing, but the trend towards it is now increasing."
The outsourcing tendency is spurred by businesses’ increasing demands on IT. With mobility, big data, and cloud services, the genuine business value that IT can lend to companies is accelerating. However, parallel to this development, the complexity of the underlying infrastructure increases. This, in turn, collides with the fact that many IT departments are forced to focus on operation instead of development.
Over time, this may cause a sluggish and insufficient infrastructure, which will be increasingly challenged by the need for innovative IT solutions, agility, and trustworthy data. It also creates a gap between the business’s expectations of IT, and IT’s ability to meet those expectations.
"It is very hard to meet business objectives with a rigid infrastructure unfit to handle changes, and with an overhead to comply with GxP regulations, and it is very difficult to be innovative if daily operations consume all of the resources," says Thorhauge.
"CIOs are turning to infrastructure outsourcing as a solution: you get continuous technology renewal, you get scalability according to varying needs, enhanced data quality, and you free up valuable resources from routine work – and, with NNIT, you get compliant infrastructure and a service provider that understands GxP."
Compliant GxP cloud services
According to Thorhauge, compliant GxP cloud services are also coming more into the focus of life science CIOs.
"We launched NNIT GxP cloud in 2011 and usually customers start with a pilot project; that is to say, a less critical application," he says.
"When they feel comfortable with the GxP cloud and can see that it is fully compliant with GxP requirements even though the cloud runs in a virtualised environment, they are then ready to move on to more sensitive systems. We saw the same skepticism when operating system virtualisation became available. Today, no one is afraid to run GxP systems on a virtualised platform."
Torben Thorhauge believes that the same rationale will apply for cloud solutions, but the perception of the GxP cloud still needs to mature.
"We have experienced an increased interest in NNIT’s GxP cloud but everyone is waiting for one of the big life sciences companies to venture into cloud with more than a pilot project," he says.
"On the other hand, I believe that if a company does so today, it will have a clear competitive advantage, not only on the costs side, but also, more importantly, because they become more agile. Instead of running an IT project for two to three years, they can, within a few months, launch a solution that can grow with time – this provides new business opportunities."
NNIT is also involved in the work of developing guidelines for GxP cloud solutions as part of the International Society for Pharmaceutical Engineering’s good automated manufacturing practice (GAMP) guidelines.
"Moving to the cloud is a difficult challenge for life sciences companies with many regulatory obligations," Thorhauge explains. "It is only natural, that the industry awaits guidelines on the use of cloud technology and white papers that describe possible solutions, as there are many practicalities involved when contemplating a move to the cloud.
"It may take a couple of years before the compliant GxP cloud services become mainstream, but we definitely see that companies are looking for a competitive advantage," he adds.
