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Articles

 

 

This article focuses on some common issues with the performance of Advanced Product Quality Planning (APQP). Companies often race to meet APQP requirements, without establishing systems and processes that optomize use of the data they've collected during the process. In addition, companies often lose track of where they are in terms of deliverables met and outstanding requirements, leading to backtracking, missed deadlines and deliverables with clients, and missed opportunities for lessons learned that could have a positive impact on future projects.

Quality Magazine

by IBS VP of Implementation Services Mary McAtee

 

This article examines how document control software functions as the cornerstone of a quality system, helping companies manage policies, procedures and work instructions, perform quality processes, and achieve compliance with FDA and ISO regulations.

Quality Magazine

by Michelle Bangert

 

This article explores the ISO 13485 requirements for medical device manufacturers.

Quality Magazine
by Steve Wichelecki

 

By implementing IBS software, Optos, Inc. was able to complete their FDA Audit in record time, passing all of the compliance benchmarks with flying colors. This article describes how implementing a quality system can steamline your quality-related business processes, while improving the efficiency and reliability of your compliance efforts.
Managing Automation Magazine
by Beth Stackpole

 

This article explores strategies for shortening audit time, and details how Aspen Aerogels uses IBS software to demonstrate compliance and provide better visibility into business processes.
Baseline Magazine
by Michael Vizard

 

This article offers essential strategies for choosing the right auditor/registrar for ISO/TS 16949:2002 certification.
Quality Magazine
by IBS VP of Implementation Mary McAtee

 

By implementing enterprise compliance management software, FDA-regulated companies can achieve compliance with the FDA’s Quality System Regulation and drive continuous improvement.  This article describes how enterprise software can help users streamline document control, integrate quality processes, and respond to post-market data.
Quality Digest
by IBS VP of Marketing Dan Riordan

 

McAtee offers strategies for successfully choosing and implementing compliance management software in order to get the maximum benefit for your organization.  The article includes tips for evaluating the software vendor, rollout, interfacing with IT, and employee training.
Quality Digest
by IBS VP of Implementation Mary McAtee

 

In order to mitigate the high risks posed by their equipment, medical device manufacturers must continually perform risk management processes throughout the product life cycle.  This article offers guidance about performing risk assessments and establishing risk controls from the design and development stages through post-market evaluation.
Medical Product Outsourcing Magazine
by IBS VP of Marketing Dan Riordan

 

McFadden outlines the benefits of trading in manual document control methods for automated systems, including lower costs and greater efficiency.  She also discusses the various types of document control software on the marketplace, and the advantages of scalable software that is connected to all aspects of the company’s quality system.
Quality Magazine
by Maggie McFadden

 

After implementing IBS’s employee training & qualification software, Ingersoll-Rand managed employee certifications, and streamlined document control.  This article profiles how they improved their employee training program and generated lasting results.

Quality Magazine

by Larry Adams

 

Learn an auditor's secrets for streamlining document control processes.
Quality Digest
by IBS VP of Implementation Mary McAtee