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

Opinion: 3 Reasons to Consider SaaS for Quality Management Software

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

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

Elements of a Modern Change Management System

Energy & Utilities Industry Medical Device Industry FDA Regulated Industries Pharmaceutical Industry Quality Management Regulatory Compliance Management

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

The Importance of Documenting Enterprise QMS Process Requirements

Energy & Utilities Industry FDA Regulated Industries Regulatory Compliance Management

NERC Reliability Standards Require Centralized Data Management

NERC Compliance Energy & Utilities Industry Regulatory Compliance Management

Take Action for ISO 13485:2016 Certification Preparedness

FDA Regulated Industries Regulatory Compliance Management Risk Management

NERC to Expand CIP Reliability Standards

NERC Compliance Energy & Utilities Industry Regulatory Compliance Management Risk Management

Blog Home TAG: Quality

FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus

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

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

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

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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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