eMDR Archives - Page 2 of 10 - 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 CATEGORY: eMDR

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 [...]

Risk Management + Adverse Event Reporting: FDA Guidance

In eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management

Posted December 16, 2016

Risk Management + Adverse Event Reporting: FDA Guidance

Risk management and adverse event reporting protocols for medical device manufacturers have been addressed by a new FDA guidance. Producing and controlling electronic records will be critical to [...]

By Michael Causey

In eMDR, Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance Management

Posted July 14, 2015

FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures

It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for – and often finding – during their visits in the first half of 2015 We start [...]

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Quality Management Software

AssurX Quality + ComplianceA single versatile software system can improve quality, compliance and streamline workflow.

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