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.

How to Respond to an FDA Warning Letter or 483 Observation

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

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6 Elements of a Modern Change Management System

Learn the 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 mandatory.

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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, including companion Implementation Checklist.

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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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AssurX FDA 21CFR Part11 Compliance Bulletin

Take 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

Learn tips for efficiently controlling records for compliance and security.

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Focus on HACCP Issues

Take a closer look at HACCP and where FDA inspectors are focused.

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