Manufacturing Industries AssurX Quality Management Solutions Blog

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Opinion: 3 Reasons to Consider SaaS for Quality Management Software

Medical Device Industry Pharmaceutical Industry FDA Regulated Industries 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 CATEGORY: Manufacturing Industries

Tips for Preparing for an ISO Certification Audit

By Stephanie Ojeda

In Manufacturing Industries, Document Management, Medical Device Industry, Quality Management, Regulatory Compliance Management

Posted January 31, 2023

Tips for Preparing for an ISO Certification Audit

Recent ISO data shows a growing number of certificates being issued across all standards. A notable increase is especially seen in ISO 9001 (Quality Management), ISO 14001 (Environmental [...]

An Overview of the FDA Draft of CSA Guidance for Quality Systems

By Stephanie Ojeda

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

Posted January 19, 2023

An Overview of the FDA Draft of CSA Guidance for Quality Systems

In September 2022, the (FDA) released draft computer systems assurance (CSA) guidance clarifying software validation requirements for medical device manufacturers. The guidance significantly [...]

6 Common Reasons External Quality Audits Fail

By Stephanie Ojeda

In Manufacturing Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management

Posted January 12, 2023

6 Common Reasons External Quality Audits Fail

In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, and activities are effectively aligned with desired objectives. The FDA and [...]

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