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.
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:
Continue reading "Microsoft Dynamics AX Mobile"
- Operational efficiency needs to improve.
- Employee-facing mobile apps provide competitive differentiation.
- Want to accelerate time-to-decision making.
- Workforce productivity needs to increase.
- Increasingly mobile workforce.
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.
Continue reading "Synchronizing the Supply Chain with Mobility"
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.
Continue reading "Don’t Be Afraid To Start Small With Big Data"
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.
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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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.
Continue reading "Enterprise Mobility and Employee Productivity – They’re Not Mutually Exclusive"
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.
Continue reading "MDSAP: Another Attempt at a One Size Fits All Audit"
Today’s global ERP solutions offer robust, fully-functional supply chain management capabilities. And they need to. Customers, both consumer and commercial, expect a lot from a business and its ability to supply materials and products. The demand side of the supply chain has become, well, more demanding. Perhaps it’s the fact that customers have product and company information available at all times via social networks and mobile technology. Or it could be the speed at which consumers receive their items from online retailers, who have made same-day delivery routine. The consumers in these B2C relationships start wondering why they can’t have similar response in their B2B transactions at work.
Continue reading "Effective Supply Chain Management Needed to Meet Increasing Customer Expectations"
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"