06/18
2018
iBASEt Extends the Digital Thread with Release of iBASEt PLM Connector
New product bridges manufacturing process planning and production execution with product design information in PTC Windchill
Author archives: iBASEt
11/10
2017
Benefits of Adopting the Digital Thread
Complex manufacturers are adopting the digital thread faster than ever before to keep up with the tidal shift to Industry 4.0 and …
02/13
2017
Benefits of Dock to Stock (DTS) Programs for Complex Discrete Manufacturers
The Dock to Stock (DTS) receiving method provides benefits to complex discrete manufacturers by delivering materials directly to the point of use.
01/03
2017
Why a Quality Management System Isn’t Enough to Satisfy 21 CFR Part 820 and Part 11
How Manufacturing Operations Management (MOM) ensures more for medical device manufacturers striving to satisfy U.S. FDA regulations.
12/15
2016
Why Medical Manufacturers Need Manufacturing Operations Management (MOM)
In the world of medical device manufacturing, mistakes on the plant floor can have dire consequences. That’s why meeting FDA requirements such as 21 CFR Part 820, 21 CFR Part 11 and ISO 13485 are so critical.
10/06
2016
Does Your MES Support Effective Product Genealogy for Medical Device Manufacturing?
In today’s global medical device manufacturing environment, supply and manufacture is more dispersed and nuanced than it ever has been.
07/15
2016
Achieve Cradle-to-Grave Bi-Directional Traceability with Best-of-Breed MOM
Globally, medical device manufacturers continue to face stricter government regulations and escalating costs.
03/01
2016
A Better Approach to Maintaining Device History Records
Current FDA regulations encourage medical device companies to use the latest collection technologies and improve their delivery systems.
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.
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