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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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Join Us At Oracle Industry Connect 2018

Perficient is sponsoring Oracle Industry Connect April 10-11 in New York City, and we would like our valued clients to be there. Several key representatives from our life sciences practice will be available to discuss any of your ongoing or upcoming initiatives. Mike Grossman, General Manager Dennis Dougherty, Business Development Executive Rudolf Coetzee, Business Development […]

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FDA Ciphers Update: What To Consider If You Have Argus Safety

The FDA has decided that it will update the ciphers for their Electronic Submissions Gateway (ESG), but what does this mean for you? Here is the message that was received: FDA Electronic Submissions Gateway (ESG) will update ciphers and SSL protocols in Production on Saturday, January 20, 2018 at 9:00 PM EST. Please make sure […]

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Argus Safety 8.1.1 – 2 Things To Know

Oracle Argus Safety 8.1.1 was officially released today, so I thought I would share a question that came up recently from a hosting customer. The customer asked us what the difference between Argus Safety 8.1 and 8.1.1 is. While there are your standard bug fixes and improvements, there are two significant changes that companies should […]

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3 Insights Into The Cloud From Oracle’s Q3 2016 Earnings Call

  Oracle’s third quarter 2016 earnings call was peppered with strong revenues and big wins in various categories. But what was most striking was the incredible progress the enterprise software powerhouse has made with regard to the cloud. Between CEO Safra Catz, CEO Mark Hurd (yes, they’re both CEOs), and Executive Chairman of the Board […]

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Importance of the Cloud: Scaling, IaaS, PaaS

There’s always been a level of redundancy built into large Production or even smaller mission critical systems. Scaling out is the answer to both by adding additional compute resources as well as increase the overall uptime reliability of a system. This principle is no different when it comes to the cloud, than it is on-premises. […]

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First Quintiles, Now PPD. Oracle Siebel CTMS Is Rockin’ It

  These days, it appears as if most of the big contract research organizations (CROs) are using Siebel CTMS, Oracle’s clinical trial management system. In June of this year, I wrote about Quintiles’ use of Oracle Health Sciences applications, including Siebel CTMS. Now we’re talking about PPD, another top-5 CRO. 

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Yes, Perficient Is Looking To Hire People Like You

  As long as you have the experience listed in the job descriptions. But, to put it simply, if you’ve worked in the life sciences industry, you’re already ahead of the game. Check out the job openings we have on our life sciences team and apply if you’re interested. We’ll keep your application secret. Promise. […]

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Can We Integrate Clinical And Safety Systems In The Cloud?

  In our last “cloud fact or fiction” post, we discussed the ability to migrate clinical and pharmacovigilance data to the cloud. Let’s jump right in and talk about system integrations in the cloud. Claim #7: Clinical trial software in the cloud cannot be integrated with other systems. 

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Are Hosted Systems Open Or Closed Under 21 CFR Part 11?

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: When Argus is hosted by Perficient, is it considered an open or closed system for the company that contracted Perficient to host? 

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