BLOG
ComplianceQuest insights and Perspectives

How Next Generation Electronic Quality Management Systems Equip Medical Device Companies to Handle FDA’s New Approach to Quality Regulations- Part IV

In a future shaped by data and connectivity, modern EQMS stands out. While not required to participate in FDA’s Case for Quality pilot, EQMS makes collecting, processing, and analyzing the required data faster and more reliable compared with disparate or legacy QMS systems, spread sheets, or paper documentation. The value of automation within a centralized…

How Next Generation Electronic Quality Management Systems Equip Medical Device Companies to Handle FDA’s New Approach to Quality Regulations- Part III

Compliance managers using EQMS are understandably concerned about how legacy systems will stand up to the changes introduced by FDA’s Case for Quality. At a recent webinar about the FDA initiative, an audience member asked, “For EQMS, how does this appraisal approach impact what companies can expect in the future?” While not endorsing any brand…

How Next Generation Electronic Quality Management Systems Equip Medical Device Companies to Handle FDA’s New Approach to Quality Regulations- Part II

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…

How Next Generation Electronic Quality Management Systems Equip Medical Device Companies to Handle FDA’s New Approach to Quality Regulations- Part I

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 “rightshore” various business processes. But,…

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…

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…

Driving Organizational Efficiency and Performance through Effective Training Metrics

Regulatory authorities such as FDA and ISO require organizations to maintain certain standards in processes and quality to stay compliant. These requirements are sometimes complex to un-derstand and implement. Complying with requirements specified by these standards involves making changes to several processes and controls in an organization. Organizations invest enor-mous time and money in meeting…

×