Posts Tagged ‘Life Sciences’

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 […]

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 […]

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 […]

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, […]

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 […]

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, […]

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 […]

Artificial intelligence (AI), cognitive computing, and machine learning are becoming more common in the industry. The need to scour and analyze large sets of data is giving life sciences companies new intelligence that would never have been realized before. The technology is making a big impact on healthcare decisions and patients. When it comes to […]

When it comes to drug approvals, 2017 was a great year for the pharmaceutical industry. According to Reuters, the number of drugs approved in the United States was the highest number in 21 years. In fact, the 46 novel drugs that were approved was more than double what was approved in 2016. This figure doesn’t […]

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 […]

We’re all intrigued by rankings and flock to them for good reason. When it comes to ranking companies by market capitalization, you can assume that the named companies are leaders in their own right. They never stop innovating. They never stop changing. They never stop investing in their business. These are companies that we can […]

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 […]