eCTD Cloud Vendor Selection Q&A

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GlobalSubmit recently held an educational webinar entitled Regulatory and the Cloud Vendor Selection.

Software as a service (SaaS, typically pronounced [sæs]), often referred to as “cloud technology” or “on-demand software,” is a software delivery model in which software and its associated data are hosted centrally, typically in the Internet.

The combination of ever-more-abundant bandwidth, increasingly powerful processors, and inexpensive storage is broadening the choices for designing, deploying, and using software. Software as a Service (SaaS)—meaning delivering software over the Internet—is increasingly popular for its ability to simplify deployment and reduce customer acquisition costs.

There are several benefits for life sciences companies to shift their technology operation to the cloud, but in order to realize those benefits it is imperative that your company chooses the right vendor to meet its needs. If you were able to join us, we hope that you now have a better understanding of how to choose the right cloud vendor to meet your regulatory needs.

We received some great questions during the webinar, and have provided these questions and answers below.
Q: How does GS ensure that their solution meets validation requirements?
A: Validating applications deployed in a cloud environment follows basically the same process for validating applications deployed in-house. We develop the same set of documentation and follow the same procedures for testing to ensure the production system performs as expected and documented in our requirements. Additionally, we work with our clients to ensure the system is validated and managed in a controlled environment following their internal procedures, as needed. As indicated in the presentation, extensive due diligence is performed in order to select the right cloud vendor to ensure they have the necessary documentation and processes in place to be able to demonstrate a controlled and secure environment. For example, a qualified cloud vendor will already have adequate and tested back-up and restore procedures and a disaster recovery plan in place in order to bring a validated system into production and maintain it accordingly.

Q: What is your definition of a cloud and how does it differ from server-client architecture?
A: Cloud computing uses network access to connect to a pool of computing resource (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal effort.

Q: How do your cloud cost benchmarks compare to adding virtual servers in-house?
A: On the cloud side, you need to calculate the size of the server and number of hours of usage. On the in house-side, you have to ask what level of capacity do you have for your server, what is the cost and the cost of your staff per server, and compare the two. Cloud vendors often report a 4 to 1 savings. This cost is usually born from personal cost and increased server utilization on the Cloud. If your servers are all running at 100% utilization and your datacenter is large enough to attract the talent to maintain those server, an in-house datacenter would be cheaper.

Thank you again to all of those who participated in the webinar. For your reference, the webinar slides are now available for download here.

We look forward to seeing you at future events.

Author: GS

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