Articles

 

 

 

Quality Management

 

Integrating Quality and Compliance Electronically

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

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

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

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

Learn how CompliantPro helped Optos, Inc. pass their FDA Audit in record time.

Managing Automation Magazine, December 2007
by Beth Stackpole

 

 

Greasing the Audit Skids by Exposing Business Processes

Learn how IBS software streamlined audits for Aspen Aerogels.

Baseline Magazine, April 2006
by Michael Vizard

 

 

Reducing Audit Anxiety: Five Steps to Short, Successful Audits

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

Learn these important steps to choosing the right registrar and auditor.

Quality Magazine
by IBS VP of Implementation Mary McAtee

 

 

 

 

Compliance Management

 

 

How Enterprise Software Facilitates FDA Compliance

Learn how the adoption of a total systems approach can help you to achieve compliance and drive continuous improvement.

Quality Digest
by IBS VP of Marketing Dan Riordan

 

From FDA Compliance to ISO 13485 Certification

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

Confused about MDR requirements? Knowing these basics will help you avoid the consequences of late or incomplete reports.

 

 

Taming the Software Dragons

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

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

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

Discover the importance of performing risk management activities throughout the product life cycle.

Medical Products Outsourcing Magazine, October 2007
by IBS VP of Marketing Dan Riordan

 

 

 

 

Document Control

 

 

Push for Paperless

Electronic document control systems increase efficiency and reduce human errors.

Quality Magazine, March 2006
by Maggie McFadden

 

 

Get a Grip on Document Control

Learn an auditor's secrets for streamlining document control processes.

Quality Digest
by IBS VP of Implementation Mary McAtee

 

 

Advanced Product Quality Planning (APQP)

 

 

Lessons Learned

Focuses on some common issues with the performance of Advanced Product Quality Planning.

Quality Magazine

June 2008
by IBS VP of Implementation Mary McAtee

 

 

 

 

 

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