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Compliance

Playing by the Rules: The Critical Role of Compliance in Olympic Medical Device Use
Compliance ► August 7, 2024

Playing by the Rules: The Critical Role of Compliance in Olympic Medical Device Use

The health and safety of athletes are super important during any sporting event, especially at the Olympic Games, where the stakes are high, and the competition is intense. In recent years, technological advancements have enabled...

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QSR Transition to QMSR
Compliance ► December 13, 2023

QSR Transition to QMSR

In early 2022, the US Food and Drug Administration (FDA) issued its proposed rule for medical devices, the Quality Management System Regulation (QMSR). This proposed rule connects and aligns 21 CFR Part 820 Quality System...

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The 12 Days of Quality
Compliance ► November 30, 2023

The 12 Days of Quality

Deck the halls with boughs of…quality? That’s right! The holiday season is upon us, and while we’re busy spreading cheer and joy, let’s not forget to celebrate the unsung heroes of our industry – Quality...

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How a GLP Facility Can Go Digital in a Compliant Manner
Compliance ► July 10, 2023

How a GLP Facility Can Go Digital in a Compliant Manner

We recently completed a workshop on How a GLP facility can go digital in a compliant manner at a large multinational company. The 3-day workshop, led by Jackie Torfin and Brendan Hyland, started with a...

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Recent Posts

  • Printing Electronic Data Doesn’t Solve Data Integrity Issues—Here’s Why
  • Why the FDA’s LDT Rule Was Necessary—Even If the Court Disagreed
  • International Women’s Day – This One’s for the Girls!
  • From Team Member to Team Leader: Navigating the Challenges of Management
  • Training Effectiveness vs. Training Competence: Understanding the Nuances

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