medical device Articles - Perficient Blogs
Blog

Posts Tagged ‘medical device’

  • Topics
  • Industries
  • Partners

Explore

Topics

Industries

Partners

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, […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more

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, […]

Read more

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 […]

Read more

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, […]

Read more

Top 5 Pharma & Medical Device Blog Posts From March 2018

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. Collaboration In Pharma Is Surging […]

Read more

Collaboration In Pharma Is Surging

There is probably no headline that comes out of a pharmaceutical company more frequently than one relating to collaboration. Collaboration between pharmaceutical companies and academia, hospitals, start-ups, and large pharma has been happening for a long time. However, the focus on collaboration has intensified in recent years, and for the right reasons. In fact, you […]

Read more

Top 5 Pharma & Medical Device Blog Posts From February 2018

Now that March 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 February – they’re ranked in order of popularity, with number one being the most viewed piece. Interest In AI And Cognitive […]

Read more

Philanthropy Continues To Increase In Pharma

It’s true that life sciences companies are in the business of developing medicines, devices, and other therapies to treat medical conditions. It’s also true that hearing stories of patients who have been helped by the use of medicines and medical devices can be incredibly rewarding. However, many successful companies feel the urge to take more […]

Read more

Sustainability Is More Important Than Ever In Pharma

The business of sustainability remains an important aspect of pharmaceutical and medical device companies for a number of reasons. A recent report from the Boston Consulting Group found that pharmaceutical companies that have more ethical operations are more profitable and valued than their competitors. In fact, to reduce the risks associated with environmental, social, and […]

Read more

Innovation And Digital Are Changing Life Sciences

The industry continues to flex its muscle when it comes to innovation through the use of digital technology. While life sciences companies over the years have tended to be laggards in this respect as compared to other industries, they’ve really come to understand the importance of using digital technology. It’s a necessity. It’s an integral […]

Read more

Top 5 Pharma & Medical Device Blog Posts From January 2018

Now that February 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 January – they’re ranked in order of popularity, with number one being the most viewed piece. [Guide] 2018 Pharmaceutical And Medical […]

Read more

Building Better Safety Profiles With Real-World Data & Evidence

The use of real-world data has exploded in recent years and will continue playing a crucial role in 2018. Almost every major pharmaceutical and medical device company conducts real-world studies to build better safety profiles for their products, as well as support initial study findings. Real-world data can come from a variety of sources including […]

Read more

[Guide] 2018 Pharmaceutical And Medical Device Industry Trends

Knowing for certain what the future holds is impossible. Trends, on the other hand, are more predictable. In fact, there’s probably no better indicator of emerging or future trends than recent history. That is exactly how we determined the trends we anticipate seeing in the pharmaceutical and medical device industries in 2018. This guide does […]

Read more

6 Applications And 1 Real-Life Example Of IoT In Life Sciences

I recall hearing Michael Farrell, the CEO of ResMed, speak about how important the Internet of Things (IoT) is to his company. There’s probably not a better case study of IoT in life sciences than ResMed. The medical device company specializes in sleep apnea products and solutions. They also happen to be the makers of […]

Read more

Consider This When Migrating To Argus Safety

When I’m approached by clients to discuss safety projects, it is generally about implementing Oracle’s Argus Safety, upgrading the system, or discussing their ability to comply with regulatory requirements. Recently, I was asked about migrating from a legacy drug safety database to Argus. We discussed the methods available, such as leveraging an Oracle dump, a […]

Read more

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 […]

Read more

Subscribe to the Weekly Blog Digest:

Sign Up