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White Papers | Technical Discussions | Special Topics

If you need to gain additional in-depth knowledge about quality management, FDA regulatory insights, NERC Compliance, eMDR or special features information about CATSWeb, we offer numerous papers on a variety of topics. Please see below for our current selection. All papers are provided to you in Adobe's PDF format. Come back often for newly released publications. If you want to read customer case studies, click here.

Please check all that apply:
NEW! FDA Proposes Mandatory MDR Submissions: What's Next? The FDA just released (August 2009) its draft guidance document for eMDR. Learn what it's all about, and you need to do to get ready for the mandate.
NEW! FDA Importer Guidance for Medical Devices: Part of a broader effort to place more responsibility for quality control on manufacturers, this guidance is the FDA's roadmap for producing safe products. Learn how to meet or exceed the agency's important new requirements.
NEW! eMDR eBook - 3rd Edition: Leveraging the benefits of eMDR (Electronic Medical Device Reporting
NERC Compliance: Ensuring Reliability Through Proactive Standards Management
Medical Device Companies -- Before you invest in an electronic complaint handling and regulatory reporting system, make sure to request this document first! Complaint Handling and Regulatory Reporting System Requirements Matrix
AssurX Issue Brief: FDA's Part 820 Quality System Regulation for Medical Devices
7 Methods for Integration with CATSWeb
Are You Ready for the New eDiscovery Regulations?
FDA Warning Letters Focus on HACCP Issues
Show Your True Quality: The Importance of Leveraging an Enterprise-Wide Quality Management System
Food for Thought: The FDA Gets Serious on Electronic Records Management
Record Retention Management Policies: It's all in the timing
A Blueprint for Electronic Record Retention: How Much? And For How Long?

How to leverage the FDA's electronic record retention requirements to understand what you need to save and clean out what you don't.
CAPA and Quality Systems: FDA Inspectors are Demanding Stronger Programs
Part 11 and Legal Issues: Impress FDA Inspectors and address legal requirements of 21 CFR Part 11
The Business Case for Part 11 Compliance: How complying with the FDA's 21 CFR Part 11 requirements results in better overall business operations.
CATSWeb Web Services: A Fresh Approach to Web Services Technology. (12 pages, in-depth technical discussion)
CATSWeb FDA Compliance Bulletin: How CATSWeb complies with the FDA's 21 CFR Part 11 requirements. (8 pages)
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Wright Medical selected CATSWeb because of its ease of use, configuration, and flexibility in creative workflows

CASE STUDY | Medical Device
Fischer Imaging: Implementing a Proactive Enterprise-wide Quality System
CASE STUDY | Med Device & Pharma
Bausch & Lomb: Implementing a Global 21 CFR Part 11 CAPA System
CASE STUDY | Fine China
Lenox: Implementing a Global Productivity and Quality Improvement Program
CASE STUDY | Oil Pipeline
Alyeska Pipeline Service Company
Compliance Management: A comprehensive approach to assuring management actions and commitments




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