Tag Archives: compliance

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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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From The Editor's Desk

Regulatory Intelligence: Meeting the Demands of Today’s Global Regulatory Market

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The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and international pre-market and post-market requirements, as well as key pain points in achieving regulatory compliance throughout the product lifecycle.

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Risk Logic

In Search of Flawless Devices

Risk Logic

Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks), effective (performing as expected), and state of the art (compared to industry benchmarks).

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Sinisa Belina, Amplexor
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Beyond Compliance: The Business Case for Smart, Real-Time Quality Monitoring in Life Sciences Manufacturing

By Siniša Belina
Sinisa Belina, Amplexor

The pandemic put unprecedented pressure on drug and medical device production, underlining the growing challenge of monitoring, analyzing, reporting and acting on quality. It became clearer than ever before that the more fragmented processes become, the more critical it is that they can be assessed and managed for consistent quality. At the same time, innovative tools and best practices have emerged.

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