Posts Tagged ‘Systems’

Key Takeaways About Compliant IT Systems In The Cloud

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, […]

Tips And Best Practices For Compliance In The Cloud

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 […]

How To Use Contracts For Regulatory Compliance Of Cloud Systems

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 […]

How To Qualify Cloud Vendors

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 […]

Who Is Responsible For The Compliance Of Cloud Systems?

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 […]

Cloud-Hosted Terminology: Types Of Systems

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, […]

Refresher: Which IT Systems Are Regulated

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 […]

Maintaining Regulatory-Compliant Cloud Solutions

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, […]

Essential in the Airline Industry: Vision and Commitment

While the term “business transformation” has been floated around for decades, digital and the deployment of modern technology remain the cornerstone of today’s investment decisions. Customer expectations have changed greatly in recent years. Strong brands like Facebook, Amazon, Apple, Netflix, and Google, which investors often refer to as FAANG, have changed consumer behavior. Not only […]

The Backbone of Operations in the Car Rental Industry

Digital transformation can absolutely be thought of as improving a website through which a car rental company sells its used vehicles – an important source of revenue for the company. It can also be thought of as enhancing a mobile app that enables customers to make, modify, or cancel reservations, view a car’s mileage and […]

Cost-Cutting and Technology Investments in the Airline Industry

Cutting unnecessary costs and investing in technology (e.g., digital, planes) to support the business is a complex task, but certainly a requirement for long-term growth. Fuel costs – the number-one non-labor expense for airlines – can only be hedged to the degree the petroleum market allows and that is by and large outside the control […]

Customer Satisfaction in the Airline Industry

Customer satisfaction is always top of mind for airlines. Unhappy or disengaged customers naturally mean fewer passengers and less revenue. It’s important that customers have an excellent experience every time they travel. On-time flights, good in-flight entertainment, more (and better) snacks, and more legroom might be the obvious contributors to a good experience and more […]

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