There is a reason that cloud computing is the hottest topic in ERP solutions. With the cloud, valuable data becomes available to employees throughout the organization whenever and wherever they are, thereby boosting productivity. With more and more of IT dollars being put toward devices other than PC workstations (think mobile), the computing structure of the organization must be available 24/7/365. The cloud also promises to scale quickly as an organization grows, including the ability to connect distributed employees into a cohesive team.Continue reading "The Value of Hybrid Cloud Solutions"
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The term “Millennials” has become popular to describe people born between the years of 1976 and 2001. Millennials are characterized by their aptitude with all things digital, their constant connection to social media and deep concern about their work/life balance. According to the US Bureau of Labor Statistics, this group will make up almost 50% of the workforce by 2020. Why do they matter to businesses? The way Millennials work has begun to indelibly and irreversibly shape the way companies operate, especially in the realm of mobility.Continue reading "Millennials and Mobility: Adapting to the Changing Face of the Workforce"
Quality compliance is never a static concern. With changes in programs and new guidance documents it may feel like trying to hit a moving target. During online discussions, many device manufacturers indicated that their areas of biggest concern were inspections, followed by product recalls, warning letters, UDI implementation and CAPA. Clearly, no one is alone in their concerns.Continue reading "What Keeps You Up at Night? 2014 in Review for Medical Device Companies"
Android navigation drawer is a handy tool for displaying menus and navigation items. More often than not, those navigation items need to have a specific look and feel, other than the default textual display. In this example, the navigation drawer is consisted of an icon and a text description.Continue reading "Custom Android Navigation Drawer Items in Xamarin"
In the US, there are two regulatory processes used to obtain marketing clearance for a device. 510(k) is a type of premarket submission where there is a substantially equivalent predicate device. Without this comparison, the submission would require a PMA (Premarket Approval). This process applies to most class II devices. The submission must demonstrate the same safety and effectiveness characteristics of the predicate device. A successful submission results in the permission to distribute and sell. A PMA requires evidence from controlled trials to prove the safety and effectiveness of the device.
The submission process is challenging and it changes periodically so it is important to keep current. In December, the FDA issued draft guidance on how it tracks clearances that change ownership. This can happen when a product or company is divested to another. The FDA receives notification of this change but difficulties can sometimes arise when trying to trace the history. The electronic registry developed in 2012 facilitates this tracking. Regardless of the past ownership, there remain key issues to focus on when preparing the submission.Continue reading "510(k) Clearance Without the Snags"
Everyone knows that an organization has reporting requirements within their accounting departments, but an organization should think beyond financials and recognize that compliance is relevant to so much more.Continue reading "The Power and Flexibility of Dynamics AX in Compliance"
It seems with every key stroke, data is collected and stored by a third party. This huge amount of information may be a treasure trove for companies to learn more about the effectiveness of a treatment or the performance of a device. Some say it holds great potential for improving patient care. But like most big data stockpiles, others become squeamish at the thought of alternate uses for the data.Continue reading "Individualized Care, Big Data and Privacy"
At the end of 2013, Ted Shelton, an executive at Cognizant, wrote about what he dubbed “the digital transformation.” Shelton defined the digital transformation as how organizations must re-evaluate their activities based on the capabilities of information technology. Information technology allows us to do ever more with fewer resources. One of the driving forces behind this evolution is enterprise mobility.Continue reading "Mobility and the Digital Transformation"
Gartner recently released their ERP Magic Quadrant, and for another year Microsoft Dynamics AX has been left out of the Leaders Quadrant due to a perceived lack of the Partner Channel's ability to implement AX in a global, large enterprise. (See Merit Solutions' white paper: The Challenges of Working with the Wrong Consultant.)
Most organizations realize that choosing and installing an ERP system is too complex to be handled in-house. The process of adopting a new ERP system invariably involves working with a third-party consultant. In fact, the success of the deployment and use of an ERP system depends heavily on the quality of the consultant, so heavily that a business might consider bringing in other help if the project starts falling apart.
So what are some red flags that the consultant selected may not be up to the task?Continue reading "ERP Consultant Warning Signs"
It’s possible to improve your Xamarin.Forms app experience with a custom layout splash screen using Xamarin.Forms for Android.
In your Android project under Resources/layout add a new file Splash.axml (if needed, add all resources used in your splash layout: Icon.png image to Resources/drawable folder, apptheme_color to Resources/values folder).Continue reading "Create a Custom Xamarin.Forms Splash Screen Using a Layout"