Quality Management AssurX QMS and Compliance Articles

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: Quality Management

AssurX Demonstrating Regulatory & Quality Management Solutions at 2019 RAPS Conference

By Stephanie McArdle

In Manufacturing Industries, Document Management, AssurX News + Success Stories, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management

Posted

AssurX Demonstrating Regulatory & Quality Management Solutions at 2019 RAPS Conference

Next week, AssurX will be exhibiting at the annual Regulatory Affairs Professionals Society (RAPS) Convergence Conference 2019 in Philadelphia. RAPS is the largest global organization for those [...]

Cybersecurity for Medical Devices – Who’s Accountable?

By Stephanie McArdle

In SaaS & Cloud Computing, Manufacturing Industries, Patch Management, eMDR, Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance Management, Risk Management

Posted

Cybersecurity for Medical Devices – Who’s Accountable?

Cybersecurity for Medical Devices is on the agenda for the U.S. Food and Drug Administration (FDA) September 10, 2019: Patient Engagement Advisory Committee. PEAC will be discussing and making [...]

Validation of a regulated computer system – what’s the big deal?

By Stephanie McArdle

In Manufacturing Industries, Quality Management, Regulatory Compliance Management, Uncategorized

Posted

Validation of a regulated computer system – what’s the big deal?

Anyone who has been part of a successful validation effort for a regulated computer system (IT system) should consider themselves lucky souls. Throughout my own personal development, this was [...]

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