The Impact of ISO 13485
The publication of the ISO 13485:2016 standard in March of this year realizes work that began in July 2014 with the rejection of the first Draft International Standard (DIS)
August 03, 2016
Tag: quality
iBASEt Discusses Big Data, Industry 4.0 and the Digital Thread at HxGN LIVE
Leveraging a framework for the Digital Thread allows you to streamline shop floor and supplier operations with existing machine communication technology. This Industry 4.0 Framework is the answer to controlling and optimizing your Complex Discrete Manufacturing Environment.
June 22, 2016
Does Your Manufacturing Execution System Support Quality Management?
Over the past few years, customers across all industries have demanded higher quality from manufacturers. Couple that with the evolving quality standards and your company’s task to uphold quality products becomes an ongoing challenge.
June 22, 2016
The Advantages of Integrating Quality in MES
A recent article in Quality Magazine details a laundry list of symptoms of Quality Management Systems (QMS) that remain immature through sloppy collecting and handling of data.
June 06, 2016
iBASEt Keynotes Industry 4.0 Discussion at HxGN Live
With over three days of keynote presentations from international industry experts, networking opportunities and an immersive “Innovation Pavilion,” this conference will enable attendees to discover new and innovative ways to work smarter.
May 26, 2016
A Better Approach to Maintaining Device History Records for FDA Compliance
Current FDA regulations encourage medical device companies to use the latest collection technologies and improve their delivery systems.
March 02, 2016
Digital Thread Connects Four in Manufacturing
Manufacturers have the unrelenting need to innovate and create products faster with higher levels of quality. A major problem that stands in the way of accomplishing these goals are the preexisting silos throughout the product lifecycle value chain.
February 18, 2016
Solumina Deployed by BAE Systems to Achieve Operational Excellence
Earlier in the implementation, BAE Systems initiated a project to harmonize operations process management across its Electronic Systems’ manufacturing facilities, utilizing Solumina’s process planning, manufacturing execution, and enterprise quality management tools.
February 03, 2016
New Acronyms from the FDA: UDI and GUDID
On September 24, 2013, the FDA established a Unique Device Identification (UDI) system to identify all medical devices sold in the U.S. starting from the point of manufacture, through all distribution channels, and to the eventual sale to the consumer.
January 28, 2016
Top 5 Risks You Need to Know Before Selecting a Manufacturing Execution
Taking the time to do proper risk management, identifying and mitigating risks, can protect the organization from unnecessary costs and heartache. In this post, you will find key risk factors that you must understand in both approaches to ensure a smooth path to implementation.
January 25, 2016
5 Ways Manufacturing Execution Systems Will Accelerate Quality in Medical
Quality must become the catalyst that unifies the diverse departments of any organization if it is going to strive.
December 23, 2015
MOM Can Help with Your Quality Complaint System
Every time a company receives notification that there is a problem with their product, no matter what the reason for the complaint, at a minimum it has to be documented and investigated.
December 10, 2015
Not a Fix It and Forget It – Continuous Improvement
From new engineering and shop floor staff coming in and needing education to the use of new tools, process, and yes, even software, continuous improvement is essential.
December 07, 2015
Tackling Medical Device CAPA Deficiencies
A Corrective Action System is an effective and essential tool, but it needs to be efficient to be truly effective.
November 17, 2015
FDA Software Validations Are Tied to Manufacturer’s Implementation
Software vendors cannot sell you “FDA approved software” or “FDA validated software” because it is not the software itself that is validated.
November 10, 2015
Uncover Hidden Medical Device Cost of Quality Issues with MOM
MOM systems oversee all the stages of production from the acquisition from your suppliers of raw materials to the completion of the finished product.
November 03, 2015
Cost of Quality Roadmap for Medical Device
In order to make strides towards operational excellence, medical device manufacturers need to gain greater insights into their Cost of Quality
October 29, 2015
Medical Device Quality: 5 Strategies for Improvement
Read about strategies that will help strengthen your medical device manufacturing quality by improving your Enterprise Quality Management.
October 28, 2015
5 Strategies Of High Performance Quality Management Teams
All manufacturers are on a quality management journey with many progressing quicker than their competitors, attaining more in just a few years than their competitors attain in a lifetime.
July 29, 2015
Why ERP Isn’t the Answer to All Your Enterprise Needs
Many companies spend a small fortune and years of effort implementing an Enterprise Resource Planning (ERP) system only to find themselves still struggling to manage their manufacturing operations.
April 14, 2015