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Medical Device Security-Beyond a Data Breach

In today’s technology obsessed world, even the delivery of healthcare is dependent on software driven devices. Some are standalone, others are networked together. With the ever growing web of connectivity and the movement towards personal medical care, security issues predictably arise. Hacking has become so common place, we are no longer surprised when it happens. Losing your credit card information is bad enough but what if a wearable device was compromised by an anonymous cyber criminal? Remember, the motivation for someone to control another individual’s pacemaker or insulin pump is irrelevant, the point is that if something can be hacked, someone will find away to do it. Hackers may use these devices as another means to troll for personal information.

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Enterprise Mobility Facilitates and Enhances Collaboration

Mobile technologies allow employees unprecedented freedom. They can work outside of a traditional work environment, and they are no longer confined to completing assignments between the hours of 9 to 5. This freedom can create challenges: how do employees, especially those who are part of a remote workforce, work together to achieve business goals if they aren’t in the office at the same time? Fortunately, enterprise mobility can present solutions to the predicaments it produces. Enterprise mobility enables employees to collaborate more effectively than ever before.

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Free Webinar: Product Serialization and Tracing

In an ongoing effort to mitigate the risks patients are exposed to when using medical devices and pharmaceutical drugs, the FDA has recently enacted two regulations for companies in these industries:

  • Unique Device Identifier (UDI) regulations require most medical devices distributed in the United States to be documented and tracked.

  • The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical companies to include product transaction information in an electronic or paper record every time ownership of the product or material is transferred.

Join us for our next webinar in our Mastering Compliance and Innovation Life Sciences Executive Series:

Product Serialization and Tracing
Wednesday March 4, 2015
12:00pm Eastern (9:00am Pacific)

Register now for the Product Serialization and Tracing Webinar

Underestimating the scope and scale of these regulations could put your company at risk. In this session, we will discuss real-world applications of UDI and DSCSA using Microsoft Dynamics AX – while diving into the fits, gaps, and solutions for complying with regulations and mitigating the risk associated with non-compliance.

Microsoft Dynamics AX Mobile

Whether you are ready to embrace it or not – we live in a mobile society. But are you ready to take Microsoft Dynamics AX Mobile?

It is important that executives today do not underestimate the value of giving all employees, partners, and customers anytime-anywhere connectivity to your business.

According to an Aberdeen Group report, Mobility and BPM Responsiveness, the top drivers for mobility initiatives include:

  1. Operational efficiency needs to improve.
  2. Employee-facing mobile apps provide competitive differentiation.
  3. Want to accelerate time-to-decision making.
  4. Workforce productivity needs to increase.
  5. Increasingly mobile workforce.
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Synchronizing the Supply Chain with Mobility

Enterprise mobility can have a positive effect on every business process. The supply chain is no exception. This realm has long been dominated by a reliance on paper. However, as other departments make the transition to using more mobile devices, so too can manufacturing, warehouses and transportation. Enterprise mobility can make the supply chain more efficient and cost effective through synchronization.

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Don’t Be Afraid To Start Small With Big Data

As digital information continues to accumulate at a phenomenal rate, businesses are left wondering how to mine this big data in order to gain a competitive advantage. The task can be overwhelming even for large organizations. Smaller organizations without the resources to put together an entire team devoted to collecting and analyzing data may feel inadequate to leap onto the big data bandwagon. A few strategies can make the process of harnessing the power of big data more manageable for any business.

Start by identifying goals and asking questions prior to collecting Big Data.

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Green Validation Webinar: Automating the Validation Process

Managing validation document lifecycles and deliverables can be error-prone and time-consuming. Which leads to the question: "Can paperless validation be a reality?"

Join us for our Green Validation Webinar on Tuesday, February 24th, at 12:00pm Eastern (9:00am Pacific) as Valarie King-Bailey, CEO of OnShore Technology Group, discusses effectively managing validation processes and documentation in a consistent and green manner.

This session will cover the following topics regarding ERP validation:

  • Initiating the validation activities early in an ERP project.
  • Eliminating paper documentation and slow approval processes.
  • Reducing time to completion by 50%.

Learn how to ensure compliance, streamline validation, and reduce costs by registering now for this webinar!

And then take a look at the other upcoming sessions we have in our Mastering Compliance and Innovation Life Sciences Webinar Series

Life Sciences Executive Webinar Series - "Mastering Compliance and Innovation"

Merit Solutions and OnShore Technology Group are excited to launch a new monthly Life Sciences Executive Webinar Series titled "Mastering Compliance and Innovation”. This series will identify ways Life Sciences organizations can excel beyond the basics and leverage innovative technologies to achieve continuous improvement and global success.

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Enterprise Mobility and Employee Productivity – They’re Not Mutually Exclusive

Mobile devices and cloud technology allow employees to work wherever and whenever they want. However, how do supervisors or managers know that these employees are actually working if they’re not on site? The fear that employees won’t be productive because of mobile technology is one which holds back many enterprises from embracing mobility. A mobile workforce can still be a productive one, though. The enterprise can ensure productivity through mobility by implementing effective technologies and engaging employees.

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MDSAP: Another Attempt at a One Size Fits All Audit

There are significant challenges to meet the regulatory requirements to sell products globally. It is necessary to be audited by regulators from these countries or by an accredited independent group. In some cases, countries will not accept a report that was generated for another jurisdiction. For some companies this can mean subjecting to many inspections and for international regulator’s inspectors to rack up the miles. This can become expensive and also slow the process of new product introduction.

To address this issue some regulatory authorities are developing a program to allow a single inspection team from a recognized auditing organization to satisfy the requirements of the participating countries. The Medical Device Single Audit Program (MDSAP) is in a pilot phase. This has the potential to be a win-win for both regulators and manufacturers as they can utilize their resources more efficiently.

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