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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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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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Increasing Cloud Use [Trend To Watch]

Gartner recently put out a press release that is quite memorable. It begins with: “By 2020, a corporate ‘no-cloud’ policy will be as rare as a ‘no-internet’ policy is today.” The chances are low that many companies maintain such success-hindering policies, but there are plenty of companies out there that are slow adopters, especially in […]

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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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Top 5 Life Sciences Blog Posts From March 2017

Now that April 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 March – they’re ranked in order of popularity, with number one being the most viewed piece. Oh My, Where Has The Time Gone? […]

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Consolidating IT Applications To Cut Costs In Banking

Cost reduction remains a priority among financial institutions. Aside from re-negotiating contracts with vendors, consolidating IT applications is an ongoing trend in the industry. When speaking on the topic of expense reductions, Ralph W. Babb, chairman and CEO of Comerica, said, “We will enhance our technology capabilities, while reducing our overall spend by optimizing our […]

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4 More DevOps Considerations for 2017

Software development and DevOps trends are front and center for 2017 enterprises ready to put their customer engagement into overdrive. As we have seen over the past month, more and more trends are pointing towards an increased interest. One of the major surveys to hit the market in the recent week is RightScale’s State of […]

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Gartner’s List Of 5 Cool Vendors In Life Sciences

If there’s one list that gets a lot of touch attention in life sciences, it’s Gartner’s Cool Vendors in Life Sciences. While the name of the list helps grab attention on its own, the companies it features are typically just as interesting. This year’s list happens to carry a few companies that we’ve blogged about, […]

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4 Technology Initiatives At J.P. Morgan

  When J.P. Morgan speaks, most financial institutions listen. A recent Wall Street Journal article outlined the US bank’s $9.4 billion technology spending plan, 40% of which will be allocated to new investments and technology. While new investments and technology are essential, part of the company’s plan is to also trim excess cost. 

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Gartner And IDC Predict Growth In Cloud Spending, Even In Pharma

  Key findings in a new Gartner report showed that cloud computing is likely to grow 16.5% in 2016, reaching $204 billion in spending. According to Sid Nag, director, cloud technologies at Gartner Research, “The market for public cloud services is continuing to demonstrate high rates of growth across all markets and Gartner expects this […]

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The Industry Cloud Landscape Infographic That Caught My Attention

  Gordon Ritter, co-founder and general partner of Emergence Capital, wrote an article in TechCrunch the day after Thanksgiving in which he spoke about the prowess of “industry cloud companies” – companies that develop software for specific verticals. “These companies might not be well-known outside specific industries, but ask anyone within an industry vertical and […]

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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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A Dose Of Technology At CVS’ MinuteClinic

  It was exciting, fast, and, surprisingly, painless. Let me tell you take you back to last week. I got out of my car, walked a few hundred feet, and entered through the glass double doors. Behind the shelves of candy and healthcare products, what do I see? A MinuteClinic. No one was there to […]

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