Quality Management 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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A Guide to Automating Quality Management Systems: Essential Strategies for Success and Pitfalls to Avoid

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

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GMP Audits: Moving from an Adversarial to a Cooperative Process Whitepaper

Common reasons why GMP audits fail, and strategies to improve your audit process for greater efficiency and quality improvement.

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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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Dispelling Common Misconceptions About Software Validation

This AssurX solution brief addresses common myths and misconceptions about computer system validation.

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This document provides an overview and guide of what to consider when evaluating an automated compliance management system.

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AssurX FDA 21CFR Part 11 Compliance Bulletin

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

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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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AssurX System Integration White Paper

This AssurX System Integration white paper details and compares methods for AssurX enterprise quality system integration.

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