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ComplianceQuest insights and Perspectives

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…

The Power of Watermarking

The earliest use of a watermark was around the year 1800. Watermarking was used to ensure the originality of the document. It typically consisted of an image, an emblem, or just plain text that appeared in various shades of lightness/darkness. It was sometimes created manually when the paper was manufactured by introducing variations in thickness…

CAPA – More Than What You Think It Is

Achieving greater quality in manufacturing, you need a means to implement improvements to an organization’s processes so that they eliminate causes of non-conformities or other undesirable situations. This process is commonly referred to as CAPA or Corrective and Preventive Actions. One cannot achieve compliance to ISO 9001, ISO 13485, GMP and myriad other quality standards…

A Fast Path to New Employee On-Boarding

Compliance standards set up by authorities such as Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA) and International Organization for Standardization (ISO) aim at enabling organizations to conduct their operations with good business practices. Quality management is one of the critical components of these standards. A need for trained and competent personnel…

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