FDA's New eMDR Requirements: Is Your Company Ready? [ROUNDUP]

Significant operational changes are coming to manufacturers under the FDA's umbrella of control. Scheduled to go into effect August 14, 2015, in order to better ensure timely reporting of adverse events, companies must submit electronic reports through an FDA provided portal rather than through the currently allowable method of manual data upload. Is your company prepared to make the transition? Read on in this week's roundup for more on this and other articles.

Now It’s Time to Deploy Wireless in the Factory

Quickly adapting to changing market demands and conditions is an initiative that never quite leaves a manufacturer’s list of responsibilities. Adopting the correct technologies and implementing efficient processes aids in the potential for achieving such goals. For this instance, we are going to take a look at how a wireless plant floor can achieve competitive advantage. Cisco and Rockwell Automation recently announced some advancements in their joint venture, Converged Plantwide Ethernet (CPwE), with Factory Wireless being the latest solution within this portfolio. Factory Wireless delivers exactly that, unified wireless for industrial applications allowing for the sought after plant floor flexibility. Learn more…

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Ten Ways Big Data Is Revolutionizing Manufacturing

In a recent Forbes article, Louis Columbus, VP of Worlwide Marketing at iBASEt, focuses on advanced analytics and how manufacturers are changing their use of internal data. There are many benefits that organizations can experience from analyzing big data, such as streamlining value chains, reducing costs, and increasing yields. This article provides insightful details on how big data is revolutionizing the industry in ten ways. Here are a few of them:

• Increasing the accuracy, quality, and yield of biopharmaceutical production
• Accelerating the integration of IT, manufacturing, and operational systems, making the vision of Industrie 4.0 a reality
• Better forecasts of product demand and production, understanding plant performance across multiple metrics, and providing service and support to customers faster
• Integrating advanced analytics across the Six Sigma DMAIC framework to fuel continuous improvement

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Preparing Your Organization for New FDA Requirements and eMDR

In February of this year, the FDA finalized the Electronic Medical Device Reporting Rule that will be mandatory come August 2015. This new rule sets the parameters for manufacturers and importers to use a specific electronic format when reporting events to the FDA. Currently, manufacturers have the ability to manually upload files into the database. Manufacturers are now challenged with gathering the correct data into a data management system to adhere to the more precise record formatting. Learn how your company can prepare for these changes, here.

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8 Questions Answered from Last Week’s EHS Management Software Webinar

For those who were unable to tune in live for LNS & Environmental Leader’s event, it was focused on the evolution and growing importance of Environment, Health & Safety (EHS) across manufacturing and production industries. Also discussed was how leading EHS professionals are deriving additional business value from integrating EHS initiatives across the entire value chain as part of a larger Operational Excellence strategy. Due to the time limit, many of the attendee questions or comments could not be addressed. However, whether you attended or not, our team has focused on the most critical areas within this recap. Read more…

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