3 October 2011| Article by Birgitte Agergaard
Article by Birgitte Agergaard, Marketing Consultant, NNIT
After a couple of years of following the cloud debate from the sidelines and mentally walking the mile from “Cloud what?” to “Cloud how”, it is now time for life science companies to walk that walk, seize the new opportunities and take advantage of the cloud. With the introduction of NNIT’s GxP Cloud, reservations and concerns, such as security and compliance, are about to become archaic.
GxP defines the life science industry. The very concept of GxP being meticulous control and even meta-control to achieve unconditional quality may appear to be in conflict with the perception of the cloud: speed, agility and flexibility – the latent nightmare of any QA. No wonder the GxP issue is one of the principal reasons why many life science companies have refrained from migrating applications to the cloud.
NNIT’s GxP Cloud is an enhanced cloud, as it takes the GxP-dimensions into consideration. When engaging with the GxP Cloud, your business can take advantage of the general cloud economy such as scalability, elasticity, pay-per-use and availability and still fulfil the GxP requirement – without any compromises.
In fact, it is our hypothesis that the next level of GxP IT solutions is facilitated by the cloud with its automated controls. Cloud is a logical step in the GxP environment.
Automation enhances control
The key signifier of cloud is automation. When you combine automation with GxP and the immanent requirement of immaculate quality and pervasive control, you have a perfect match. The vast majority of IT incidents are linked directly to employees unknowingly causing errors – also, in a GxP environment characterised by gates, checks and double checks. In the GxP cloud, this source of error is neutralised as processes are automated, minimising human intervention. This is also why the GxP cloud may be even more secure and in control than current solutions, as the risk of human error on physical machines is minimised.
Compliance in the cloud
In the life sciences, it is all about control and compliance. Out of control and out of compliance means out of business. In the GxP Cloud, compliance is achieved through prequalified processes and components, which also means that the organisation, as well as the cloud platform, is constantly ready for regulatory inspections.
All components and workflows are aligned with GAMP5 and FDA/EMA and are qualified using the V-model:
• URS, FRS and TDS
• IQ, OQ and PQ
Full control of data and its location
Many companies are concerned about whether they will lose control of their data in the cloud. However, this is not the case in NNIT’s GxP cloud, as all processes regarding the handling of data are completely transparent. In case of major patching of applications, the company is notified and the process is not initiated prior to approval.
Your virtualised data are safeguarded in Danish-located data centres, subject to EU-legislation and operated by a highly experienced and GxP-certified staff.
Suitable for all regulated applications
By design, the GxP cloud can handle all regulated business applications even with high impact classification. At an initial phase, some applications are more likely candidates than others, but ultimately which application you choose to place in the cloud depends on your need for flexibility and your own risk assessment. To name a few we suggest:
• Capa
• Adverse Event
• Training systems
• Audit systems
Competitive advantage from cloud computing
The automation feature, in combination with the pre-validated components, is what makes the GxP Cloud a genuine business enabler for the life science industry.
We estimate that a saving of roughly up to 80% of the validation cost can be achieved when using cloud. More importantly, the GxP Cloud time to market as services can be ready within a day. In the long term, any in-house IT set-up would find it difficult to replicate this performance.
Also, the GxP Cloud provides an unprecedented access to the latest computer technology and a series of relevant applications, which can boost efficiency and, when properly used, create a real competitive advantage.
More information about the GxP Cloud?
Call us if you would like to know more about how to take advantage of the business enablement inherent in the cloud. Please contact Esben Schnurre, Solution Manager, NNIT here or on +45 3075 3331.