Posts Tagged ‘hosting’

Is It Time to Consider Oracle Lift-and-Shift?

Are you one of those Oracle E-Business Suite (EBS) customers who are not quite ready to go to Oracle ERP Cloud, but your servers are long since out of warranty? Have you lost the desire or expertise to continue buying and maintaining your own hardware, but you don’t want to give up control or take […]

Deploying Application Request Routing (ARR) on Multiple Platforms

In Hosting Services, we get custom requirements depending on project needs. I will share one such requirement that was unique in nature, considering the customer’s available infrastructure and the phase the project was in when the change request was raised. The Challenge On one of our website redesign projects – almost in the middle of […]

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, […]

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 […]

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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