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.
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.
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"
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"
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"
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"
When the FDA warns of further enforcement, it is not just an attempt to intimidate. There are teeth behind this procedure and companies need to stand up and take notice. Ignoring or excessively delaying a response will not make it go away, the ramifications will only increase.
Continue reading "When it Becomes Criminal"