FDA Warning Letters Archives - Quality Management Software + Regulatory Compliance | QMS Software | AssurX

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: FDA Warning Letters

2017 Recap: FDA Warning Letter Observations and Trends

In Quality Management, Regulatory Compliance Management

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2017 Recap: FDA Warning Letter Observations and Trends

FDA Warning Letters: First Half of 2017 Trends

In Quality Management, Regulatory Compliance Management

Posted

FDA Warning Letters: First Half of 2017 Trends

The FDA released 225 FDA warning letters in the first half of the year. AssurX, a QMS software provider, provides a quick snapshot detailing the FDA’s activity. Top 3 FDA Warning Letter [...]

FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus

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

Posted

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 [...]

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