White Papers | AssurX Quality Management and Regulatory Compliance

Energy & Utilities: Leveraging a Culture of Compliance

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

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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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6 Elements of a Modern Change Management System

Requirements for a Modern Change Management System

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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

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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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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