Articles
Quality Management
Integrating Quality and Compliance Electronically
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Learn how electronic compliance systems can help you save time and reduce costs. Medical Design Technology Magazine, August 2007 by IBS VP of Marketing Dan Riordan |
How to Integrate Quality into Company Culture
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Empowering quality functions helps organizations achieve compliance with regulations - both ISO 13485 and CFR 820 emphasize company-wide commitment to quality. But how can you inspire your company's employees to take an active role in quality management? |
How to Establish Stellar Supplier Quality
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Outsourcing is an effective way to keep pace with rapidly evolving technologies and trim time-to-market, but it presents significant quality challenges. Learn how to effectively manage suppliers, so you can ensure quality of goods. |
Turning Complaint Management into Customer Satisfaction
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A comprehensive complaint management system can drive better product quality and inspire customers to believe in the integrity of your products. |
Audits
Giving Up the Paper Chase
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Learn how CompliantPro helped Optos, Inc. pass their FDA Audit in record time. Managing Automation Magazine, December 2007 |
Greasing the Audit Skids by Exposing Business Processes
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Learn how IBS software streamlined audits for Aspen Aerogels. Baseline Magazine, April 2006 |
Reducing Audit Anxiety: Five Steps to Short, Successful Audits
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Don't quake in fear at the prospect of your next audit. Implement these key strategies to improve audit preparation and cut audit time in half. |
Audit your Auditor
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Learn these important steps to choosing the right registrar and auditor. Quality Magazine |
Compliance Management
How Enterprise Software Facilitates FDA Compliance
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Learn how the adoption of a total systems approach can help you to achieve compliance and drive continuous improvement. Quality Digest |
From FDA Compliance to ISO 13485 Certification
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Want to leverage your Part 820 compliance program to achieve ISO 13485 certification? Knowing these key differences between the regulations will help you develop strategic compliance initiatives for both standards. |
Demystifying MDR: Your Questions Answered
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Confused about MDR requirements? Knowing these basics will help you avoid the consequences of late or incomplete reports. |
Taming the Software Dragons
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Formulating a plan for compliance management software implementation can help you achieve long-term results. Quality Magazine by IBS VP of Implementation Mary McAtee |
Seven Steps to Performing Effective CAPA
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Corrective and preventative action failures are the most frequently cited problem by the FDA, accounting for 88% of all warning letters in 2005. Close up those gaps in your CAPA processes by implementing the program outlined here. |
Risk Management
Integrating Risk Management and Quality Control
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By integrating compliance processes for ISO 13485 and 14971, you can eliminate duplicated efforts and lower compliance costs. |
Applying Risk Management Principles to your Quality System
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Discover the importance of performing risk management activities throughout the product life cycle. Medical Products Outsourcing Magazine, October 2007 |
Document Control
Push for Paperless
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Electronic document control systems increase efficiency and reduce human errors. Quality Magazine, March 2006 |
Get a Grip on Document Control
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Learn an auditor's secrets for streamlining document control processes. Quality Digest |

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