Featured Articles
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Small Regulatory Steps For AI In SaMD
12/28/2021
Recently released guiding principles for good machine learning practice in medical devices and other regulatory documents, are giving medical device companies an indication of what regulations might look like.
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Medtech Manufacturing: From Disruption To Evolution
12/16/2021
Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.
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3 Ways To Rethink Regulatory Change In Personalized Medicine
12/14/2021
The landscape for the regulation of personalized medicine evolves as innovation in personalized medicine increases. Here are a few ways to approach regulations as opportunities, not obstacles.
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What You Need to Know About Phase-Appropriate Quality Requirements
12/9/2021
A discussion on implementation of a phase-appropriate QMS, the importance of starting early in the product development life cycle, and the advantages of digital QMS over a manual approach.
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7 Steps To Ensure CAPA Success
12/9/2021
Product development in the life sciences is a multimillion-dollar process. With this level of money on the line, good corrective action/preventive action (CAPA) processes are essential. In this blog we give a general overview of the seven steps companies need to take to successfully complete and document CAPA.
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Planned Deviations Vs. Unplanned Emergencies: Real-Time Manufacturing Intelligence Is The Difference
12/6/2021
Today’s top life sciences manufacturers are dramatically reducing deviations with real-time intelligence. Going digital gives you the power to track and control deviations. Our webinar will show you how.
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ISO Standards: Turning Hopes Into True Quality Objectives
11/22/2021
Aligning your company’s quality management practices with the applicable quality principles found in the ISO 9000 family of standards is a proven approach for turning aspirations into actual quality objectives. Here, we review key quality principles addressed in ISO 9001 and examples of ways the standard can be leveraged to reach the kinds of objectives your organization may be looking to achieve.
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FDA Inspection Preparation: SOPs, Process Maps, And Gap Analysis
11/22/2021
Process mapping and gap analysis can help manufacturers not only show the FDA that an organization is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.
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Simplifying Commercial Software Validation In Medtech Manufacturing
11/21/2021
Commercial off-the-shelf (COTS) software has dramatically enhanced medical device manufacturers’ ability to accelerate production, integrate processes, and manage quality effectively. Learn more about FDA guidelines on the horizon for COTS software and tips on how to approach validation until such guidelines are finalized.
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How Electronic Batch Records And Device History Records Close The Digital Manufacturing Gap
11/21/2021
We need to remedy the fact that the vast majority of life science manufacturers are still on paper. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.