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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

NERC Compliance Energy & Utilities Industry Regulatory Compliance Management Risk Management

Blog Home MONTH: April 2022

What is a Quality Management Review and Why Do You Need Them?

In FDA Regulated Industries, Quality Management, Regulatory Compliance Management

Posted April 28, 2022

What is a Quality Management Review and Why Do You Need Them?

This is the first installment of a two-part series focusing on the importance of a quality management review for companies in regulated industries. What is a quality management review (QMR)? A [...]

Understanding FDA Alignment of ISO 13485 with Quality System Regulation

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

Posted April 20, 2022

Understanding FDA Alignment of ISO 13485 with Quality System Regulation

The FDA’s official proposal to align its Quality System Regulation (QSR) with ISO 13485:2016 was long in coming, but worth the wait. Regulatory authorities consider it necessary to improve [...]

FDA Warning Letters Highlight Food Safety Compliance Issues

In Food & Beverage Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance Management

Posted April 7, 2022

FDA Warning Letters Highlight Food Safety Compliance Issues

The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters to date in 2022, also announcing resumed inspections after pausing them amid the Omicron surge. Furthermore, a [...]

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