With over 6 years of experience in Pharmaceutical Industry, Anoop expertise lies in validation and qualification, investigation of OOS/OOT/Outliers, deviation handling, change control, quality risk management, and data integrity compliance.

Traditionally, financial services and pharmaceutical organizations are not early adopters of the cloud. Just over 5 years ago, one would see frowns and dismissive eyes, when cloud vendors would present their value proposition. The world has since, moved on. Some interesting attempts about cloud-adoption suggest that we are willing to decide in favor of the cloud, and some pharmaceutical companies are not holding back. Emails on the cloud (aka Office 365) are common in Pharma, notwithstanding the perceived risk that critical information about products, strategy and litigation is sprinkled all over business email messages.

Commercial systems that contain customer contract information, pricing, rebates and charge backs are being hosted on external data centers, and often on the cloud. So, clearly, technology leaders have assessed that the risks to sensitive business information are not increased by moving them to the cloud. In fact, several companies may have found their in-house data centers rank lower on infrastructure quality, security, vulnerability and disaster recovery. Of course, parameters like up-time, performance and latency are not even in the ballpark. The industry experts in data center management are doing an excellent job.

At Jubilant, we are presented a “cloud-first” approach in recent years, to help us focus our premium IT talent on delivering key solutions for the next phase of our growth. It is common to hear pharmaceutical CIOs willing to adopt a cloud-first strategy on their non-GMP systems.

For GMP systems, that is far from true. In one of my stints, several cloud-service providers were asked to present their experience in hosting GXP systems. Many of the providers have made several pharma applications available to leverage on the cloud. For example, pharma companies have used such options for complaints management, safety reporting, product label, product registration, eCTD filing, and others. All of these are validated systems, and can be procured on hosted, SaaS and similar models, with references in pharma.

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 you talk to them, alongside your 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 you are looking for a cloud provider, you would be very particular to understand what they really know, and what can they deliver. A case in point – a CIO 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 seven different options, and talked to customer references of these vendors. After being satisfied with the credentials of three companies, this team initiated more detailed conversations. It took another six 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.

Cloud service providers recognize the GXP challenge, and are bringing better options to the table

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 data center 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 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, an organization is able to avoid having extensive programming-based validation-maintenance procedures.

Most application software providers for pharma industry are now offering SaaS and hosted models. In my last 10 years in association with Pharma, companies have been able to implement several solutions quickly, without the delays associated with traditional data centers. As you integrate some of these systems, you can 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.