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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: Archives

Configuration vs. Customization For Enterprise QMS Software

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

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Configuration vs. Customization For Enterprise QMS Software

The simple fact is that no enterprise QMS software will ever meet 100% of a company’s needs “as is.” Experience shows that unless you’re a small business with limited resources, you can’t work [...]

Five Form Design Mistakes To Avoid When Automating Your QMS

In Archives, Quality Management, Regulatory Compliance Management

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Five Form Design Mistakes To Avoid When Automating Your QMS

Automated process management systems are the workhorses of every modern company. These systems guide operations and improve quality and efficiency. Hidden away in the core of each automated [...]

Medical Device Manufacturers Warned For CAPA Non-Compliance

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

Posted

Medical Device Manufacturers Warned For CAPA Non-Compliance

Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical device inspection investigative focus. CAPA non-compliance is a top [...]

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