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ComplianceQuest insights and Perspectives

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…

Speed = Collaboration + Visibility

By Nikki Willett – CSO, ComplianceQuest Although medical device companies have been working closely with their supplier/partners in the past years, there has been an increased focus on Collaboration and Visibility.Because the pace of business has increased exponentially, businesses must be able to respond to new market demands with agility and innovation. Facing increasing demand…

ISO 9001: From Certification to Re-certification

ISO 9001 is a part of the ISO 9000 family of standards and the only standard that defines requirements for a Quality Management System (QMS). Organizations comply with standards like ISO 9001 to showcase their competence in offering products and services of good quality and to comply with laws and regulations of the government. One…

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