Even with the best design and steadfast controls, sometimes things go wrong. Deciding on a risk profile and executing the appropriate action may be interpretive. Manufacturers have the hurdle of coming to an agreement with the FDA. Inevitably, they don’t always agree. An attempt was made last year to bridge the divide by creating a working group consisting of manufacturers, the FDA and representatives of a nonprofit group representing healthcare technology professionals. This group seeks to create a consistent means to evaluate risk between regulators and manufacturers. They will provide feedback to the FDA on specific areas where better guidance would be beneficial.Continue reading "FDA and Industry- Bridging the Risk Management Gap"
Entries tagged as risk
The FDA has recently issued guidance regarding the risk of device accessories. They will no longer be considered as part of one big happy family included in the risk of the parent device. This new proposal states that the classification for a medical device accessory should be based on the risk they bring when used with the parent and not based on the parent’s risk. This applies to many items including apps and other connectivity technologies. This will require additional work for the manufacturer to assess the risk of perhaps multiple additions to a device.Continue reading "Device Add-Ons- Separate but not Equal- Maybe."
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"
The risk device companies assume is great. This requires a comprehensive planned approach. A policy on paper is not enough. It must be inherent in the day to day activities throughout the organization. Risk is constantly assessed and appropriate and timely decisions made. The goal is a reasonable assurance of safety and effectiveness of the product. In the simplest terms risk management results in the following:
- Identifies hazards
- Evaluates /estimates risk
- Determines risk acceptability
- Controls risks
ERP systems extend into nearly every aspect of a business, and the risk of business disruption related to the ERP system is one that most companies will avoid as long as possible. As a result, many companies delay upgrading their ERP systems longer than they should.
But these companies are ignoring the many opportunities that are available while running on newer releases of an ERP system.Continue reading "Don't Put Off an ERP Upgrade"
Organizations that have multiple sites and global operations face significant challenges to efficiency and growth. Disparate business systems, lack of supply chain visibility and control, and high IT maintenance costs hold companies back and make it difficult to support new growth initiatives.
In an effort to sustain growth and profitability, companies are now under an immense amount of pressure to reduce costs, encourage growth, and optimize their processes, technologies, and margins.
By implementing an integrated, global ERP system, executives are given a comprehensive, real-time view of the entire organization for financial reporting and operational decision making. A global ERP system also allows for consolidated and standardized processes that enable an organization to consistently optimize business functions, such as intercompany trade, multi-site planning, shared services, and book closing. Finally, a global ERP system helps companies to better collaborate across value chains and work more efficiently with other operations, partners, and suppliers.
This document outlines the traditional challenges associated with Global ERP implementations, benefits of globally adopted systems and processes, and key success factors for your implementation project.
View the white paper: Why Global ERP? Traditional Challenges, Benefits, and Key Success Factors
Nenad Simeunovic, Vice President of Services for Merit Solutions, was recently featured in the PM Network's March 2013 issue discussing using Agile Project Management techniques for ERP implementations.
Here a short excerpt from the article, titled Big Delivery in Small Packages:
Eliminating Waste: Agile is based on lean processes that remove non-value-added activities such as downtime. As a result, agile components such as daily stand-up meetings can help project teams deliver ERP-related functionalities faster. "During the 15-minute meeting, each team member says, 'This is what I did yesterday, this is what I'm going to do today and these are the obstacles I need help with,'" says Nenad Simeunovic, vice president of services at global IT services company Merit Solutions, Wheaton, Illinois, USA. "If there's a challenge, we can address it on the spot and move on. As a result, there are fewer distractions, and progress is being made on a more consistent basis."
Agile's benefits are especially appealing in the current volatile economy. "The departments are reluctant to tackle large-scale projects as one big initiative with scope, time and resources locked. Instead, they are looking more to deliver functionalities in iterations, where flexibility is allowed - even expected - due to rapid changes happening in the marketplace and in the organization. We can longer guarantee that our planning for today will be applicable in nine months," says Mr. Simeunovic.
View the digital release of the magazine, PM Network - Governing Creativity: Marrying Project Management with Innovation. The Agile ERP Project Management article starts on Page 60.
Merit Solutions has spent a lot of time over the past couple of months demoing our Microsoft Dynamics GP Risk Management Suite and its capabilities to new prospects while providing training to existing clients looking to upgrade. In both situations, two questions always seem to pop up:
- How do we make sure that we get (got) the roles and users right?
- How do we make sure we don't create a burden with tracking too many changes?
Interestingly enough, the answer to both is very simple. The implementation - not so simple.
- The first thing that each client has to ensure is that their business processes are efficient and that their ERP system is setup in a way to support those processes. The Risk Management Suite will comply to any set of rules you require - helping you increase your efficiency while making sure you comply with regulations. To receive the maximum value, efficient business processes have to be in place - and, often, that is not an easy task to complete.
- As for the second question, we recommend that tracking changes should be limited to business critical fields, tables, and processes, as that will make the system easier to implement, changes easier to track and will help a company meet compliance regulations.
On occasion, companies tend to track everything, including tables with high volume of transactions. While this is possible to do with Audit Trails, as with any other Microsoft Dynamics GP table, this is not recommended, as it will affect performance of your SQL Server, which will in turn affect all users and systems that use it.
In order to generate the highest value from the Risk Management Suite, we suggest that companies craft a smart tracking plan prior to implementation with procedures and policies in place that limit adding new tables to Audit Trails tracking without a strong business reason why.
Solutions that are Certified for Microsoft Dynamics have demonstrated development quality and compatibility with the Microsoft Dynamics product on which they run by passing rigorous software testing for Microsoft Dynamics performed by VeriTest (a service of Lionbridge). In addition, the Microsoft Dynamics partner must have customers who are successfully using the certified solution and are willing to recommend it and be a Gold Certified Partner in the Microsoft Partner Program.
For customers, Certified for Microsoft Dynamics helps identify Microsoft Dynamics solutions that have been tested for compatibility, meet high quality standards, and are successfully used by existing customers. This certification represents a significant step in elevating the standard for partner-developed software solutions for industry-specific business applications. By highlighting these solutions, Microsoft also creates new opportunities for partners to expand their reseller channel and to better promote their packaged Microsoft Dynamics solution for customers.
“This milestone demonstrates Merit Solutions’ commitment to delivering leading solutions and expertise for our customers,” said Doug Kennedy, vice president, Microsoft Dynamics Partners. “We congratulate Merit Solutions for meeting Microsoft’s highest standards of software quality and earning the CFMD distinction.”
The Risk Management Suite from Merit Solutions enables companies to manage financial, operational, and reporting risk to protect assets and maintain compliance with FDA 21 CFR Part 11 and the Sarbanes-Oxley Act. Audit Trails deliver strong tracking, tracing and reporting capabilities for business process changes that may result in risk. And with Electronic Signatures, preventative authorization controls can be activated at any place in the system where data is changed.
“Merit Solutions has always been committed to software excellence, and achieving Certified for Microsoft Dynamics status is a reflection of that commitment,” said Bill Burke, President, Merit Solutions. “This milestone also validates our dedication to providing regulated companies with the highest quality software solutions based on the Microsoft stack.”
Don't be fooled by the speculation going around about Merit Solutions' Microsoft Dynamics GP Risk Management Suite. Hear directly from Microsoft Dynamics Director of Product Management, Errol Schoenfish: Please Read: Official Risk Management Suite Transition Update“All SMB products are going through a Pricing and Packaging simplification process to better meet the demands of the customers that we serve. Part of that process is identifying the functional elements that are best served by Microsoft and those that are best served by our broad and healthy partner ISV ecosystem through the Dynamics Marketplace. Microsoft has had a valued partnership with Merit Solutions for many years. The Risk Management Suite has been a great product for us and with Merit Solutions driving the product forward I am confident that it will continue to give customers value now and in the future. Merit Solutions is also just completing the CfMD process for GP Risk Management, and now represent the first GP based Audit Trails and Electronic Signatures products that are certified at this level of quality assurance.” Errol Schoenfish - Director Product Management, Microsoft Dynamics
I am thrilled to take this opportunity to welcome the 500+ customers who currently license the Microsoft Dynamics GP Risk Management Suite to the Merit Solutions family!
Merit Solutions is the original developer of the Microsoft Dynamics GP Risk Management Suite (Audit Trails and Electronic Signatures). Microsoft acquired the product from Merit Solutions back in 2005, and since then, they have included it as part of their core Microsoft Dynamics GP offering. However, Merit Solutions has always been the company developing new releases and upgrades for Microsoft.
In an effort to simplify packaging and pricing, Microsoft has decided to remove quite a few OEM products from their core Microsoft Dynamics offerings (official announcements will be made Sept. 1). However, Merit Solutions is thrilled to have this opportunity to further enhance and improve the Risk Management Suite with a better focus on our partners' and customers' needs - enabling us to keep moving the product forward and get newer versions to market quicker. As noted above, Merit Solutions has already made the investment in getting the Risk Management Suite Certified for Microsoft Dynamics (CfMD) - the first GP based Audit Trails and Electronic Signatures products to receive such recognition.
Merit Solutions is committed to keeping all customer experiences with the Risk Management Suite consistent with previous Microsoft engagements, and all partners and customers can count on Merit Solutions to provide the same level of support, quality, and reliability that was experienced with Microsoft in the past. View our Customer Satisfaction Scores and check out some of our Customer Quotes online to learn about our satisfied customers!
If you have any questions at all about the future of the Risk Management Suite, or our commitment to your satisfaction, please don’t hesitate to contact Merit Solutions at any time to get the truth and learn more about the future of your product!