9TECH OUTLOOKMay 2016even in the ballpark. The industry experts in data center management are doing an excellent job. At Jubilant, we have supported a "cloud-first" approach in recent years, and use the cloud extensively, to help us focus our premium IT talent on delivering key solutions for the next phase of our growth. In my experience, pharmaceutical CIOs are willing to adopt a similar strategy on their non-GMP systems. For GMP systems, that is far from true. About 15 months ago, we asked several cloud-service providers to present their experience in hosting GXP systems. There are several pharma applications available to leverage on cloud services from software/managed service providers. For example, we have used such options for complaints management, safety reporting, product label, product registration, eCTD filing, and others. All of these are validated systems, and we procure the hosting services, SaaS and similar models. The big cloud players have recently started offering GXP services, and are scrambling to better understand the regulatory requirements on computer systems in our industry. So, when we talk to them, alongside our quality assurance staff, some of them bring up theoretical aspects of GXP documentation and procedural practices. Recently, making a suboptimal decision on a vendor with no pharma validation experience, it cost an organization over 12 extra months to complete their validation, apart from the escalated costs. Such costly mistakes can often have much larger implications, including missing compliance goals, making projects unviable, and employee frustration.So, when we are looking for a cloud provider, we are very particular to understand what they really know, and what can they deliver. A case in point­I was asked for advice on taking up an ambitious plan to evaluate hosting a well-established ERP system, managing over 10 sites, on a private cloud. The team in this organization looked at 7 different options, and talked to customer references of these vendors. After being satisfied with the credentials of 3 companies, this team initiated more detailed conversations. It took another 6 months for this organization to ensure that internal stakeholders, especially Quality and Compliance, were satisfied with the knowledge and practices followed by the data center.The major challenge is to be assured that business-critical applications are being placed in the hands of experienced vendors, and we are not making a decision to fall of the cliff. When we look at a critical decision like this one, it is guaranteed to be a long-drawn decision making process to confirm the ability to get managed services for a GXP system from any cloud services provider. In a decision like ERP, the idea is to outsource not just the datacenter and infrastructure, but also the issues concerning access (via WAN links/ leased lines), connections to other printers/applications, and other basic services (like SAP Basis work).Bundling all related services over to one service provider in a managed services framework ensures that you have one-throat-to-choke, while freeing up time for strategic initiatives. It is a big decision to move a validated ERP system on the cloud, but we find comfort that there are some pharma companies who have also made such efforts. Maintaining validation in such environments can be challenging, especially as virtualization is a complex maze. By making some decisions, we were able to avoid having extensive programming-based validation-maintenance procedures. Most application software providers for pharma industry are now offering SaaS and hosted models. So we have been able to evaluate and implement several solutions for our business quickly, without the delays associated with traditional data centers. As we integrate some of these systems, we expect to encounter some challenges, but the business leaders seem much happier with speedy deployments.I would recommend my fellow IT executives to further explore these areas. The role of IT keeps evolving. The good news is that cloud service providers recognize this GXP challenge, and are bringing better options to the table. By understanding and leveraging these options, IT leaders stand to focus on the "information" aspects of "information technology", and how information could be used to build better drugs and healthy lives. Cloud service providers recognize the GXP challenge, and are bringing better options to the table
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