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Cloud GxP Validation Series – Chapter 1 – Article 1 – Top Reasons to Move

This is the first article in a series about cloud GxP validation considerations, best practices and tools .  Every day, enterprises grapple with the challenges of learning to do business faster, at scale, and reduced cost. In response, they are embracing cloud solutions throughout the enterprise to meet this need, but there are risks to address when the application is intended to support GxP processes. This series explores various cloud architectures along with the associated risk. Follow to gain actionable guidance and insights into selecting, implementing, validating, and managing cloud GxP solutions to drive organizational performance, quality, and compliance. Whether you are considering a cloud GxP solution, in the process of implementing, or already live, there is something for you in this series.  The series is organized into three chapters:


    • Chapter 1: Cloud landscapes and GxP Considerations
    • Chapter 2: CSV best practices for cloud GxP solutions
    • Chapter 3: A story of digital CSV



Chapter 1

This chapter explores various cloud architectures along with the associated risks. Gain actionable guidance and insights into identifying, assessing and mitigating the risks involved with cloud GxP solutions.

    1. Top reasons to move to the cloud
    2. Architecture
    3. Advantages
    4. Risks
    5. Validation
    6. Vendor Management
    7. Agreements



Top Reasons to Move to the Cloud












Speed Time to Value

Experts tout the cloud as a means of achieving multiple business benefits, including IT cost savings, faster time to value, and better service levels. Now, more than ever, businesses measure the value of IT by its ability to meet business needs in a timely fashion. With cloud infrastructure, platform, and software, IT is closer to measuring up; however, reaping the intended benefits of cloud services takes time. There is a learning curve that is often overlooked by teams enthusiastic about delivering, and the type of cloud models employed will influence your ability to capture expected results. Our experience indicates that security and compliance are the top-cited barriers requiring specialization and expertise beyond the existing team’s knowledge. Next is business complexity, followed by application sprawl, and general lack of cloud skills within the organization. It sounds antithetical, but the speed to value takes time. Understanding your barriers and performing a gap fit analysis is a must in any successful cloud strategy. 




 A variety of cloud platform and software providers provide specialized experience in both horizontal and vertical segments. These vendors offer dedicated solutions to solve specific business problems. Horizontal options are often presented in the form of platforms, providing solutions for generic needs such as business intelligence (BI) and analytics platforms. Specialized SaaS providers will typically go a step further and offer vertical expertise, for example, a SaaS BI solution with pre-built models for pharmaceutical sales operations analytics. Specialized solutions can not only lead to faster time to value, but often, they lead to the adoption of industry standards contributing to lower business and IT costs.



Data Security



Data security takes significant financial resources and specialized talent and continuous monitoring to get right. Most IT departments don’t have the money or staff to keep pace with today’s security threats, and the cost of poor security is enormous. Cloud technology gives you agility and efficiency to instantly roll out new services and expand your infrastructure. But what about physical control, data security, user management, geographic regulatory requirements, and other security and compliance requirements Fortunately, most good cloud vendors provide the tools to implement and maintain trusted and compliant environments, solving the critical challenges of data governance, control, and ownership – no matter where you store your data. With these providers, cloud customers often gain industry-leading security, data encryption, monitoring, and constant upgrades to prevent breaches.



Software Validation



Computerized system validation (CSV) is the documented process of assuring that a software system works as intended consistently. If you are implementing a cloud-based GxP solution, one of the first things you will want to do is qualify the platform from three different perspectives (infrastructure, Network, and Application). Most cloud providers active in regulated industries will provide evidence of software validation to leverage in your organization and reduce validation costs. 



Software Updates



Cloud technology provides enterprises with the ability to deliver value faster, as well as the ability to update and deploy new features customers demand swiftly. Some vendors push updates on a regular schedule while others allow for a pull option at your discretion.  It’s important to ask for the frequency of updates especially if they are automated by the vendor.  You’ll need advanced notice inlcuding release notes in order to understand the regulatory impact to your organization.  



Economies of Scale



Companies adopting the cloud are benefiting from economies of scale. From faster implementations and data loads to fast scaling to keep pace with sudden spikes in growth. With economies of scale, companies can now imagine the previously impossible. For example, retailers can now scale up analytics in anticipation of holiday spikes and scale back afterward. Think super bowl. It happens only once a year, yet the marketing campaigns are enormous for a short period.





All the Right Reasons


Look for a leading cloud provider to make the most of your business and IT investment. Make sure you perform a gap fit analysis for capabilities, security, skills, and maintainability. If you are looking for a specialized solution, choose a provider that is comfortable in your space and has extensive experience in handling similar cloud-based projects.











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