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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, […]

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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 […]

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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 […]

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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 […]

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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 […]

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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, […]

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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 […]

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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, […]

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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 […]

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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 […]

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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 […]

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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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Operational Performance and Reliability in the Airline Industry

Operational performance (or operational reliability) is about running an airline like a well-oiled machine. Pun intended. It’s about on-time performance and completion rates. It’s about reducing involuntary denied boardings and the rate of mishandled bags. It’s ensuring that continuous improvements and efficiencies are always in motion. A smoothly run airline enhances customer perception, satisfaction, and […]

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Key Strategic Initiatives in the Airline Industry

If you listen closely to industry executives, you’ll note that many of them typically hone in on several key strategic initiatives. Naturally, there’s a crossover between them, and each one can affect the other. Operational performance or operational reliability is one. Customer satisfaction, customer loyalty, or brand strength is another. Last but not least are […]

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[Guide] 2018 State of the Airline Industry

The airline industry is scrutinized by passengers and analysts alike, mostly for two reasons. One, many people take one or more flights a year and have personal experiences that leave lasting impressions. Two, the industry’s economic impact is unprecedented. According to the Federal Aviation Administration (FAA), “Aviation accounts for more than 5% of our [United […]

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Top 5 Pharma & Medical Device Blog Posts From June 2017

Now that July is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in June – they’re ranked in order of popularity, with number one being the most viewed piece. What Exactly Is An “Adverse […]

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How To Determine Whether Your IT System Is Regulated

A couple weeks back, I launched a brief blog series about assessing and mitigating risk with regulated IT systems. This week’s post will cover the first part in a four-part approach you can use to do just that: assess and mitigate risk. Part One: System Regulated Status The first step is to determine whether a […]

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Gartner Projects Overall Worldwide IT Spending To Increase

Gartner, a leading information technology research and advisory company, released the findings of its Worldwide IT Spending Forecast. The report, which is released quarterly, is an indicator of trends across a variety of markets, including data center systems, enterprise software, devices, IT services, and communication services. According to its latest forecast, Gartner projects that overall worldwide IT spending […]

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Need To Trim The Budget? Decommission Your Old GxP Systems

  We’ve been getting a lot of requests, lately, to help companies decommission their old GxP systems. The systems were once validated and still contain GxP data that might someday need to be reviewed or analyzed, but they’re no longer being actively used. They’re just sitting there, taking up server space, undergoing basic IT maintenance, […]

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FDA Wants To Hear About Innovative Technology In Clinical Trials

  Over the last decade, the life sciences industry has gone from running clinical trials on paper or, in many cases, in Excel, to leveraging comprehensive web-based systems, such as electronic data capture (EDC) and clinical trial management systems (CTMS). But, in more recent years, the widespread use of mobile technology has enabled even more […]

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