Michael Causey 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: Michael Causey

FDA Warning Letters Emphasize Document Control System Compliance

By Michael Causey

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

Posted April 3, 2017

FDA Warning Letters Emphasize Document Control System Compliance

First quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples. Both [...]

Cybersecurity Management Expectations Clarified By FDA

By Michael Causey

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

Posted March 14, 2017

Cybersecurity Management Expectations Clarified By FDA

The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been [...]

Increased QMS Compliance Inspections For International Life Science Manufacturers

By Michael Causey

In Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management

Posted March 6, 2017

Increased QMS Compliance Inspections For International Life Science Manufacturers

International QMS compliance inspections of pharmaceutical and medical device manufacturers by the FDA and MHRA are on the rise. FDA & MHRA Increase Inspections Both the Food and Drug [...]

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