White Papers | AssurX

NERC and the Grid

Managing registration and self-certification requirements.

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

A closer look at the regulation and the importance of compliance.

How to Respond to an FDA Warning Letter or 483 Observation

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

Show Your True Quality

The Importance of an Enterprise-wide Quality Management System

6 Elements of a Modern Change Management System

Requirements for a Modern Change Management System

Complaint Handling and Regulatory Reporting System Requirements Matrix

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

Benefits of Cloud Computing in the Life Sciences Industry

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

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.

AssurX FDA 21CFR Part11 Compliance Bulletin

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

Taking the Complexity out of Computer System Validation

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

Energy & Utilities: Leveraging a Culture of Compliance

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

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.

AssurX System Integration

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

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

Tips for efficiently controlling records for compliance and security.

Focus on HACCP Issues

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

AssurX Web Services

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

Summary

White Papers

Article Name

White Papers

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Gain in-depth knowledge about quality management systems, FDA regulatory insights, NERC Compliance, industry topics.

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Assurx

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Assurx

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