08/03
2016
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)
06/22
2016
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.
06/21
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.
06/06
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.
05/26
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.
03/01
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.
02/18
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.
02/03
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.
01/28
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.
01/25
2016
Top 5 Risks You Need to Know Before Selecting a Manufacturing Execution System
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.
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