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Opinion: 3 Reasons to Consider SaaS for Quality Management Software

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AssurX BlogQuality, compliance and risk management straight talk for regulated industries.

The Importance of Documenting Enterprise QMS Process Requirements

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NERC Reliability Standards Require Centralized Data Management

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Take Action for ISO 13485:2016 Certification Preparedness

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NERC to Expand CIP Reliability Standards

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Blog Home CATEGORY: Risk Management

How to Simplify CAPA Management with a Cloud-Based QMS

In Manufacturing Industries, Food & Beverage Industry, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Risk Management

Posted July 13, 2021

How to Simplify CAPA Management with a Cloud-Based QMS

Corrective and preventive action (CAPA) violations are the most frequently cited non-compliance in FDA 483 inspection observations. In 2020, nearly 200 violations were cited among medical device [...]

Deviation vs. Nonconformance: What’s the Difference?

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

Posted June 8, 2021

Deviation vs. Nonconformance: What’s the Difference?

Recent headlines over wasted COVID-19 vaccines reveal shocking instances of lab workers not following key procedures, leading to contamination of millions of doses. Is this event a deviation or a [...]

Elements of an Effective Supplier Scorecard

In Manufacturing Industries, Document Management, Complaint Management, Quality Management, Regulatory Compliance Management, Risk Management

Posted April 6, 2021

Elements of an Effective Supplier Scorecard

Imagine if your plant is starting work on a big order. You’ve just been advised that a supplier has placed a key material on backorder. To fulfill the contract with your customer, you’ll need to [...]

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