White Papers and Special Topics

Gain in-depth knowledge about quality management systems, FDA regulatory insights,
NERC Compliance, industry topics, special features information and much more.

Energy & Utilities: Leveraging a Culture of Compliance

How to create, and the benefits, of a culture of compliance.

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How to Respond to an FDA Warning Letter or 483 Observation

Understanding 483s and Warning Letters, and how to develop a cohesive response.

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6 Elements of a Modern Change Management System

Requirements for a Modern Change Management System

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Taking the Complexity out of Computer System Validation

Computer System Validation isn’t just testing…it’s a mandate.

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EU MDR Clinical Data Checklist eBrief

This eBrief provides a brief list of items to consider before embarking on a design change to a medical device planned for distribution to one of the European Union member states.

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Benefits of Cloud Computing in the Life Sciences Industry

Make critical data more accessible while remaining secure, and improving operations and efficiencies.

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Benefits of Cloud Computing in Regulated Industries

Learn the surprising benefits of cloud-based quality and compliance management systems. Remain secure and improve operational efficiencies while keeping critical data accessible.

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Automating Your Quality Management System | Pitfalls + Essential Strategies for Success

Learn essential steps, strategies and pitfalls to avoid when planning and implementing automation within your QMS. Includes companion Implementation Checklist.

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AssurX FDA 21CFR Part11 Compliance Bulletin

A detailed look at how the quality system complies with FDA requirements.

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AssurX System Integration

Details and compares seven integration methods for connecting with other systems.

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Record Retention Management Policies: It's all in the timing

Tips for efficiently controlling records for compliance and security.

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Focus on HACCP Issues

A closer look at HACCP and where FDA inspectors are focused.

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White Papers - Quality Management and Regulatory Compliance | AssurX
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White Papers - Quality Management and Regulatory Compliance | AssurX
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Gain in-depth knowledge about QMS, FDA regulatory insights,NERC Compliance, industry topics with AssurX white papers and special topics.
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