Posts Tagged ‘SaaS’

According to Gartner, “It is impossible to provide the platform for any digital strategy and run an effective API program to benefit from the API economy, without full life cycle API management.” Digital platforms such as mobility and IoT require businesses to establish an API platform strategy that supports new computing models such as hybrid […]

Enterprises will move beyond cheap fixes and instead seek innovative app services in order to modernize their businesses in 2019, according to Forrester’s “Predictions 2019: Cloud Computing” report. Forrester believes that 2019 is the year that the cloud comes to the forefront for enterprises. Many companies look set to decide that now is the time […]

Oracle continues to update EPM Automate on a regular basis. Today, we’re going to take a look at what some of recent updates have to offer Oracle Enterprise Performance Management Cloud customers.   What is EPM Automate? Before we touch on the latest enhancements, let’s explain EPM Automate’s purpose. EPM Automate is a command line […]

Editor’s Note: This guest blog post comes courtesy of Gail Cole with Avalara. Variable in all states, sales tax laws can appear mercurial at times. Washington state’s on-again, off-again taxes on candy and bottled water, for example, could make a person’s head spin. Yet tax laws can also seem horribly rooted in the past, as is often the […]

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, […]