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Don’t Make the Mistake of Having Separation between Your ERP (Enterprise Resource Planning) and your QMS (Quality Management System)
3/15/2013
Regulatory compliance in the medical device industry is serious business. At stake are patient safety, doctor and company reputations, and the potential for large fines and negative publicity if something goes wrong due...
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Life Sciences Guidebook: Best Practices for Selecting & Implementing FDA Compliance Software Solutions
8/7/2012
As the world market evolves, product lifecycles are speeding up to accommodate market demand and keep up with competing products. As a result, Quality benchmarks need to evolve as well. Risk is fast becoming the...
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Choosing and Implementing an ERP Solution as the Core of a Quality System: Medical Device Manufacturers Share their Advice
10/6/2011
White Paper Summary Choosing and implementing an ERP system is not a trivial task—especially for medical device manufacturers. Because it plays a central role in an overall quality system that must be validated...
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An Insider's Guide to Selecting a Quality Management Software System
9/2/2011
As demand for Quality Management solutions grow, so does the vendor landscape - more software vendors are providing solutions for Quality and Compliance Management than ever before. With a high demand and a large vendor...
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Enhancing Collaboration with the FDA through MedWatch Plus
9/2/2011
The Food and Drug Administration (FDA) is tasked with the job of ensuring that all products produced within medical device, food and beverage, pharmaceuticals, biologics, and all other industries are produced safely and...
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Managing your Risk Has its Rewards: Making the Case for Risk Assessment in Streamlining your Quality and Compliance Processes
9/2/2011
In today's Quality Management systems, the ability to control and correct processes is key to maintaining a high level of compliance within an organization, and in many cases, the ability to discern the overall...
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Medical Device Quality Systems Demystified: Why Companies Need Best-of-Breed ERP, PLM and EQMS
3/17/2011
Intense global pressures, such as more stringent regulatory scrutiny, tax increases and reimbursement challenges are causing stalled top-line growth for medical device organizations and prompting them to find ways to...
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EQMS Coexistence in an Enterprise Environment
4/6/2010
Quality and IT executives alike face increasing pressure to implement solutions that allow the highest level of holistic control and oversight on the quality of their operations. This pressure is further compounded by...
