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Soapbox

Automating Computer Systems Validation for Your QMS

By Davor Milosevic, Massimo Franza
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Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.

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Michael Earl
Michael Earl
Soapbox

Digitalizing Drug Delivery – What’s Next?

By Michael Earl
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Connected devices already enable remote patient monitoring by collecting real-time data, such as injection date and time. With time, these benefits are likely to grow. Following are three areas where manufacturers are exploring new uses of digitalization in drug delivery to better understand the needs of patients and healthcare professionals and create more effective devices.

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Jack Cronenwett, MD
Jack Cronenwett, MD
Reimbursement Report

How Real-World Evidence Helps Medical Device Manufacturers Drive Value

By Jack Cronenwett, MD
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More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.

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