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ComplianceQuest insights and Perspectives

Data Quality Management for Business Growth

Among the many good things automation has enabled, such as improved efficiency across operational areas, better access to data is one of the most important. Data can provide insights that can help in developing focused strategies, be it in improving production, controlling costs or increasing customer success. However, organizations are not necessarily reaping these benefits.…

Transition Smoothly to 2016 in 2019

By Feb 28, 2019, medical device manufacturing companies should have completed their ISO 13485 transition to 2016 to maintain their certification. The transition brings with it several challenges requiring changes in processes and documents, introducing new ones being, and ensuring not to lose the momentum that could risk current certification. Improvements All Around The implementation…

FDA’s Case for Quality Pilot- How New Compliance Structure Helps in the Constant Improvement of the Model

Unlike the traditional audit approach where employees are instructed to address only questions asked and refrain from volunteering any extraneous details, the new FDA appraisal model relies on collaboration with employees to discover what’s happening inside the organization relative to best practices. The interactions take place between the appraisal team and “doers” who are responsible…

The Paradigm Shift in Quality Regulatory Standards- How it Helps Medical Device Companies Evolve

Compliance managers at prominent medical device companies are collaborating with the U.S. Food and Drug Administration to reinvent the methods for meeting quality regulatory standards. Supporting this vision, the next generation of cloud-based quality management systems brings modern, collaborative, web- and mobile-friendly productivity to help compliance professionals prepare for this new world.It won’t be easy…

FDA’s Pilot Program Helps Achieve Continuous Improvement of Product Quality for Improved Patient Safety as the Ultimate Outcome

Compliance managers at prominent medical device companies are collaborating with the U.S. Food and Drug Administration to reinvent the methods for meeting quality regulatory standards. Supporting this vision, the next generation of cloud-based quality management systems brings modern, collaborative, web- and mobile-friendly productivity to help compliance professionals prepare for this new world. A growing number…

Minimizing non-compliance

5 ways to minimize non-compliance In today’s globally connected marketplace, not only is it easy to have a distributed organizational setup, but it is also the preferred way option. Availability of skilled labor, access to critical resources, cost arbitrage, ease of setting-up plants – there are multitudes of business-cases to “right shore” various business processes.…

A (Regulatory) Affair to Remember

Guest Blogger, Natalia Olive Principal, Olive Safety LLC Quality & Regulatory Network Blogs Sponsored by ComplianceQuest Inc. Remember the good old days? Back when a “regulated product” meant one that was covered under FDA rules, and that was it? We had no idea what was coming… And come it did, especially starting in 2007 with…

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