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Whitepapers, Technical Discussions & Special Topics

Gain in-depth knowledge about quality management systems, FDA regulatory insights, NERC Compliance, eMDR, special features information about AssurX software products and much more. We offer numerous papers on a variety of topics. All papers are provided to you in Adobe PDF format. Come back often for newly released publications.

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eMDR eBook 3rd Edition

eMDR eBook 3rd Edition: Leveraging the Benefits of eMDR (Electronic Medical Device Reporting) with details about the FDA's push for eMDR & their new unified IT systems
FDA Importer Guidance for Medical Devices

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
An FDA Look at CAPA & Quality Systems

NEW! An FDA Look at CAPA & Quality Systems: FDA inspectors are demanding stronger programs. Learn what they look for
New FDA Drive for Food Safety

NEW! The New FDA Drive for Food Safety: FMSA focus on prevention + food importer and manufacturer accountability
Energy & Utilities

Energy & Utilities: Leveraging a Culture of Compliance How to create, and the benefits, of a culture of compliance
NERC and the Grid

NERC and the Grid: Managing registration and self-certification requirements
CATSWeb System Integration

CATSWeb System Integration: Details & compares 7 integration methods for connecting with other systems (10pgs)
AssurX Issue Brief: FDA Part 820 Quality System Regulation for Medical Devices

AssurX Issue Brief: FDA Part 820 Quality System Regulation for Medical Devices A closer look at the regulation and the the importance of compliance
Food for Thought: The FDA Gets Serious on Electronic Records Maintenance

Food for Thought: The FDA Gets Serious on Electronic Records Maintenance Deciphering the rules for transporters & non-transporters
How to Respond to an FDA Warning Letter or 483 Observation

NEW! How to Respond to an FDA Warning Letter or 483 Observation Understanding 483s and Warning Letters, and how to develop a cohesive response
Record Retention Management Policies: It's all in the timing

Record Retention Management Policies: It's all in the timing Tips for efficiently controlling records for compliance and security
Show Your True Quality: Leveraging An Enterprise-wide Quality Management System

Show Your True Quality: Leveraging An Enterprise-wide Quality Management System Details the benefits of a central integrated system
FDA Warning Letters Focus on HACCP Issues

FDA Warning Letters Focus on HACCP Issues A closer look at HACCP and where FDA inspectors are focused
Complaint Handling and Regulatory Reporting System Requirements Matrix

Complaint Handling and Regulatory Reporting System Requirements Matrix Medical device companies: before you invest in a system, read this document
CATSWeb Web Services

CATSWeb Web Services: How AssurX uses Web Services Technology. An 11 page in-depth technical discussion
When is Zero Client not Zero Client?

When is Zero Client Not Zero Client? The zero client validation breakthrough for FDA regulated systems
Web Services in Pharmaceutical Manufacturing

Web Services in Pharmaceutical Manufacturing: How this technology efficiently solves application integration problems
CATSWeb FDA 21CFR Part11 Compliance Bulletin

CATSWeb FDA 21CFR Part11 Compliance Bulletin: A detailed look at how the quality system complies with FDA requirements
(6 pgs)

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