With concern about compliance at the top of the agenda, the pharmaceutical industry is often hesitant about being the first to adopt new IT technologies, including cloud-based computing. NNIT’s Torben Thorhauge and Jens Maagøe discuss how the GxP Cloud can change this mindset.Despite the benefits of flexibility, agility and efficiency, the issue of compliance and security has, until now, prevented the pharmaceutical sector from joining the cloud. The thought of passing on information to external vendors and possibly losing control over compliance, is, for an industry as regulated as pharmaceuticals, somewhat unnerving. “It’s a conservative sector in relation to IT,” says Torben Thorhauge, head of NNIT’s life sciences consulting unit. “Due to the requirements for validation, any solution needs to be under strict change control and configuration management.” Jens Maagøe, director of products and technology, agrees: “It’s the loss of control that worries the life sciences. When you talk about the cloud in general terms, you hear about data centres where records are floating around without your knowledge.”
NNIT, which is based in in Søborg, north of Copenhagen, Denmark, offers a range of services across the project lifecycle, from initial consultation through to implementation, operations and support. The company has long experience in providing compliance solutions to the pharmaceutical industry and believes that with the GxP Cloud, the time has finally come for the industry to lay its reservations to new technologies to rest."Not only can NNIT reduce validation costs by 80%, but it can also do so in a way that shortens the time it takes to get products to market. "“We believe that if you can provide standard applications out of a cloud with the same security and privacy measures that a company has in its traditional IT infrastructure, then we can go a long way,” says Maagøe. “With NNIT’s GxP Cloud, you get all the benefits of traditional cloud computing, such as elasticity, availability and pay per use, but with security, compliance and full data control.” One of the main ways that NNIT can cater for the pharmaceutical industry’s compliance needs is by making data centres more readily available for audits and inspections. “Our main competitive advantage is that with us you know where the data is located.” Maagøe explains. “It’s in specific data centres where our customers can come and audit us. We have built the system to have full traceability, which means you can see which specific hardware the virtual system is running on. In other words, our customers are in full control knowing they can gain access to all changes.”
NNIT is also quick in adapting to the regulatory changes that can prove so costly to the pharmaceutical industry. When the European Medicines Agency (EMA) recently introduced a requirement that pharmaceutical companies submit all product information to the EMA site, NNIT quickly developed software with a partner that could translate all the data required. “This is an urgent requirement that hundreds of life sciences companies must fulfil,” says Maagøe. “Rather than each of them individually starting a project, NNIT took the software from an independent company and made it available through our cloud.”
The GxP Cloud’s entire platform infrastructure and software as a service come pre-validated so that all that NNIT’s clients need to do is train end-users in the business processes. This is crucial in an industry where validation costs can be as much as 20% more expensive than other sectors. Not only can NNIT reduce these costs by around 80%, but it can also do so in a way that shortens the time it takes to get products to market. “It’s much easier to validate IT systems using standardised cloud computing than unique custom-built applications,” says Thorhauge. “Within a short time, we can deploy a pre-validated platform for the client and generate a precise specification. All of that will be tested according to the highest regulatory authorities, like the FDA and GAMP, the best practice standard.” When combined with the usual benefits of standardised IT technology, the GxP Cloud’s focus on regulation and compliance gives the life sciences industry a great opportunity to join the cloud in a safe, trustworthy and cost-efficient environment.