Posts Tagged ‘PaaS’

This is the final post in our series on maintaining regulatory-compliant IT systems in the cloud. In this post, we’ll go over the key takeaways from the series and then we’ll send you on your way! Regardless of how much control you have over your IT systems, if you are using them for regulatory purposes, […]

As we’ve learned in the previous posts in this series, having a thoughtful, thorough cloud vendor qualification process and intelligent SLAs in your cloud vendor contracts will help you maximize the value of the cloud while maintaining regulatory compliance. In addition, here are some tips and best practices to help you knock it out of […]

In my previous post in this series, we discussed how to qualify cloud vendors. Once that process is complete, the second step to maintaining compliance is to document your specific regulatory requirements in a contract with the cloud vendor, usually in the form of service-level agreements (SLAs). In this blog post, I include a range […]

We recently completed a 21 CFR Part 11 gap analysis engagement for a client that was largely using SaaS applications, but had no cloud vendor qualification process in place. They had just been allowing each business unit to select the applications that met its user requirements, accept whatever validation documentation the cloud vendor supplied (if […]

Any time you take advantage of a cloud service – infrastructure, platform, or software – for a regulated purpose, you are ultimately responsible for its regulatory compliance, not the cloud vendor. This is critical for you to remember. So, how can you ensure regulatory compliance of a software system you did not build, you do […]

As we continue our series on maintaining regulatory-compliant cloud systems, let’s touch on a few key terms. Below are explanations of the primary cloud-hosted offerings available in the market. Infrastructure-as-a-Service (IaaS) When you purchase a software system and opt to have a vendor host it for you instead of installing it on servers you own, […]

If your company makes drugs, medical devices, or biologics (vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins), it is regulated. If your company is regulated, then every IT system you use to design, develop, conduct trials, manufacture, package, label, store, distribute, install, or service your products is also […]

The benefits of cloud hosting – including Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and Software-as-a-Service (SaaS) – are very clear: less upfront capital, faster implementations, scalability and elasticity, and no need for individual companies to maintain physical space, hardware, and/or technical staff for support. But there are also several risks to consider, including physical and technical security, […]

Five Tips for Creating New Oracle Analytics Cloud Services (OACS) Instances Recently, I have been assisting customers with creating new Oracle PaaS instances – specifically OACS – and I have come up with a few tips for those new to the process. Tip #1:  Keep a copy of the certificate pair you generate. PaaS instances […]

Oracle Cloud BI solutions have been available for a few years now and have evolved significantly over the past couple years. If you have been using OBIEE or OBIA (Oracle BI Applications), you are in a pretty good position to start migrating to Oracle Analytics Cloud (OAC). The reason: OAC relies on a similar underlying […]

In the world of Big Data, Data engineers always strive to find a way or method to analyze, process, and compute the Volume, Velocity, and Variety of data, and to provide Data scientists with a resilient backbone to conduct their analysis. Before the introduction of the cloud platforms, all the big data processing and managing […]

A noticeable trend lately in enterprise technology is in the Platform-as-a-Service arena. PaaS is the middle layer of the cloud, above infrastructure and below applications, including software (SaaS). Middle layer technologies, or “middleware”, include 10 different categories including application servers, databases, portals, messaging, business process management (BPM), and middleware technologies. Over time, many of these […]