Adverse Event Handling Archives | Quality Management Software | AssurX

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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.

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

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Blog Home TAG: Adverse Event Handling

FDA to Sunset Alternative Summary Reporting (ASR) Program

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

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FDA to Sunset Alternative Summary Reporting (ASR) Program

The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible. The ASR program originally launched in [...]

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

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

Posted

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

FDA regulation 21 part 822 lays out the process, the rules, and the products that require postmarket surveillance. The process is an active, systematic, scientifically valid method of [...]

Risk Management + Adverse Event Reporting: FDA Guidance

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

Posted

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 [...]

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