The Case for Cloud: Why Regulated Industries Should Pay Attention!

The Case for Cloud: Why Regulated Industries Should Pay Attention!

Kumud Bhattarai, Director of Software Development & Enterprise Architect, Pilgrim Quality Solutions

Cloud computing can be loosely defined as the process by which a set of data resources are housed somewhere remote and are accessed using the Internet. Traditionally, these resources have been housed inside the data owner’s own office building behind a firewall, providing very limited or no access from the outside, and thereby, protecting these resources from outside intrusion. But the pendulum is swinging again. Forty years ago it was in the form of time-share computing. Today, in the global marketplace, an increasing number of organizations are opting to move to the Cloud – which in many respects is today’s time-share computing environment, only faster, cheaper, highly secure, reliable, and more accessible.

What is driving the uptick in Cloud implementations? Let’s compare and contrast Cloud solutions with traditional on-premise software deployments to uncover the primary motivations driving this shift. What will these examinations reveal? Is the Cloud the Future? What is the experience of Company XYZ when it opts to deploy a Quality Management Solution (QMS) for one of its strategic operational locations, in the Cloud versus on-premise?

Costs considerations come first

Life Sciences Company XYZ assembles its Quality and IT teams to evaluate a QMS platform and deployment options. Their first step is to establish a project budget based on the estimated costs of required capacity, technical and human resources, the solution deployment infrastructure, and the software and implementation cost and time frame. These are upfront costs to the company. Upfront costs are not the lone criteria, however. Company XYZ must consider the total cost of ownership (TCO) of the QMS, which includes all maintenance and upgrade costs and resources.

The TCO picture will become clear when examining post-deployment scenarios. For instance, say Company XYZ’s on-premise deployment is complete and the system is live, but then there is power outage or other system failure, and some of the company’s in-house resources are not available. Or consider that there may be seasonal system administrator staffing fluctuations that prompt user complaints about the solution being slow. The company has to quickly determine how to scale the infrastructure, and how to make it redundant to prevent single points of failure. All of these activities add to the cost of service due to the downtime and actual physical procurement of new resources.

Following a Cloud deployment, Company XYZ would be covered in the disaster scenario, and resources would have no impact on the QMS’ performance. Typical Cloud providers offer such standard capabilities as automatic integration, backup and recovery, ongoing access to the company’s data, and continuous data protection.

Scalability is a practical consideration

Suppose that Company XYZ is looking to increase its product portfolio and add manufacturing sites in two additional countries to support product demand. In this scenario, when the QMS is deployed on-premise, software upkeep and data capacity may quickly become strained, reducing productivity, and requiring additional resources. In short, in an on-premise deployment, the exciting prospect of the company’s growth will be tempered by increased overhead costs.

Cloud deployment allows XYZ Company to scale its QMS easily as the company expands. Cloud environments typically allow for spontaneous growth and provide virtually unlimited processing power and storage space. In the Cloud, the QMS applications are more resilient and readily available through the availability of hosting and network redundancies. While enterprise expansion may still bear some costs, such as the addition of user licenses, they are reasonable when additional hardware, infrastructure, and management overhead and other unseen costs are removed.


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Security is an advantage, not a drawback

Based on cost alone, one would think Company XYZ would have no hesitation about implementing its QMS in the Cloud. So why is there still a reluctance among some organizations like Company XYZ to make the move? Perhaps the answer lies in a perceived lack of security that stereotypically shrouds hosted or Cloud environments. Or perhaps it is felt that if Company XYZ deploys its QMS on-premise, it will have complete control of the system. But will it be able to maintain control and support global users 24/7/365?

While it can be argued that some Cloud providers are more secure than others, almost all of them provide round-the-clock security measures such as intrusion detection to ensure data and intellectual property is protected, and performance and availability checks to ensure the software is running continuously. And without exception, it is rare that any Company has the ability or resources to invest in the levels of security and infrastructure that leading hosting and cloud providers have in place and maintain every day.

Compliance is a mandatory consideration

There is one more key consideration for Company XYZ to bear in mind. As a growing organization and leading player in a highly regulated industry, its leadership understands the critical nature of regulatory compliance. Undoubtedly, it takes every measure possible to ensure its operations are compliant with the latest standards and its regulatory audit record is clean. When it undertakes a QMS implementation initiative, Company XYZ will want to ensure its system is fully compliant as well, and that it remains so as regulations change over time.

Should it choose to deploy in the Cloud, 3rd-party compliance will be just as critical. Almost all Cloud-based systems today are certified compliant to frameworks like SOC, HIPAA, PCI, FIPS, etc., indicating that their frameworks have passed rigorous audits and are secure for use within any highly regulated industry. It’s table stakes. However, having platforms and solutions that are vendor-validated prior to release, as well as the ability to audit the vendor and data centers for one’s self, will ensure that regardless of risk profile, you are selecting the best QMS solution and host alternative.

The Pilgrim Cloud keeps the focus on Quality

Pilgrim Quality Solutions offers its SmartSolve® Enterprise Quality Management Software (EQMS) both on-premise and in the Cloud. The Pilgrim Cloud lets companies focus more on enhancing quality and compliance processes and less on managing the technology behind their quality management solution.

Pilgrim’s Cloud Managed Services not only monitors and supports customer’s ongoing operations, but performs platform and solution upgrades on behalf of our customers. With all of its deployment benefits, including performing the technical validation and all the up-front capital investments, the burden of maintaining the QMS rests with Pilgrim, and allowing clients to start realizing its benefits sooner.

Kumud Bhattarai

Director of Software Development & Enterprise Architect, Pilgrim Quality Solutions