WHITE PAPERS & SPECIAL TOPICS

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

FDA Importer Guidance for Medical Devices

Examine the FDA’s roadmap for producing safe products & placing the duty for more quality control on manufacturers. Learn how to meet the agency’s requirements.

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The New FDA Drive for Food Safety

The FMSA focus on prevention and food importer and manufacturer accountability.

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NERC and the Grid

Managing registration and self-certification requirements.

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AssurX Issue Brief: FDA Part 820 Quality System Regulation for Medical Devices

A closer look at the regulation and the importance 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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Show Your True Quality

The Importance of an Enterprise-wide Quality Management System

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Complaint Handling and Regulatory Reporting System Requirements Matrix

Medical device companies: before you invest in a system, read this document.

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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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When is Zero Client Not Zero Client?

The zero client validation breakthrough for FDA regulated systems.

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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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Taking the Complexity out of Computer System Validation

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

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eMDR eBook - 3rd Edition

Leveraging the benefits of eMDR (Electronic Medical Device Reporting)

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An FDA Look at CAPA and Quality Systems

FDA inspectors are demanding stronger programs. Learn what they look for.

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Energy & Utilities: Leveraging a Culture of Compliance

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

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AssurX System Integration

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

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Food for Thought: The FDA Gets Serious on Electronic Records Maintenance

Deciphering the rules for transporters and non-transporters.

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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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AssurX Web Services

How AssurX uses Web Services Technology. An 11 page in-depth technical discussion.

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Web Services in Pharmaceutical Manufacturing

How this technology efficiently solves application integration problems.

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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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