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5 Pillars of Modern Enterprise Quality Management Systems

Energy & Utilities Industry FDA Regulated Industries Regulatory Compliance Management

AssurX BlogQuality, compliance and risk management straight talk for regulated industries.

Take Action for ISO 13485:2016 Certification Preparedness

FDA Regulated Industries Regulatory Compliance Management Risk Management

AssurX BlogQuality, compliance and risk management straight talk for regulated industries.

2017 Recap: FDA Warning Letter Observations and Trends

Quality Management Regulatory Compliance Management

NERC Reliability Standards Require Centralized Data Management

NERC Compliance Energy & Utilities Industry Regulatory Compliance Management

Configuration vs. Customization For Enterprise QMS Software

eMDR Medical Device Industry FDA Regulated Industries Pharmaceutical Industry Quality Management Regulatory Compliance Management

FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus

FDA Regulated Industries Pharmaceutical Industry Quality Management Regulatory Compliance Management

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FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus

In FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management

Posted May 30, 2017

FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus

After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batch of warning letters focused on pharmaceutical manufacturing quality issues in the first quarter of 2017. Examples [...]

Prioritize QMS Process Automation or Risk Failure

In eMDR, Food & Beverage Industry, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management

Posted April 17, 2017

Prioritize QMS Process Automation or Risk Failure

A common pitfall in QMS process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at once and streamline the [...]

Avoid QMS Automation Failures with the Right Implementation Team

In eMDR, Food & Beverage Industry, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management

Posted March 20, 2017

Avoid QMS Automation Failures with the Right Implementation Team

Even after decades of eQMS availability, a staggering number of projects still suffer when the QMS implementation team isn’t right, ready and responsible. Regardless of your QMS software [...]

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