The goal of each medical device manufacturer is to produce safe and effective products. These manufacturers are responsible for carrying out postmarket surveillance activities to monitor and collect the performance of their products. In the current regulatory environment, companies are under scrutiny for their complaint procedures and their ability to react and respond.
The FDA annually receives hundreds of thousands of medical device reports of serious harm, deaths or malfunctions. These are not only from the manufacturers but also the end users. The regulation provides a means for the FDA to monitor significant issues regarding medical devices.
Continue reading "Medical Device Reporting - Getting it Right"
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
Risk can take many forms. Certainly, the most concerning is the risk to the patient but risk to an operator or employee must also be considered. There are regulatory and legal considerations and finally, there are issues that propose a business risk.
Continue reading "Risk Management for Life"
A high quality product is the goal of most Life Sciences companies. Quality by design is touted in many industries. If you build it correctly from the very beginning, there will be fewer problems once the product is in a customer’s hands. To this end, a managed process for developing a product is employed. This contains interrelated procedures that make the core of the development process. Design controls make discrepancies more evident and ensure that once the product is transferred to production it will consistently meet requirements.
Continue reading "Excellence By Design"
Social media has grown from its simple beginnings of sharing personal information, pictures, opinions and current activities. Companies now utilize its power to reach customers regarding products and specials and news agencies send out headlines and teasers. The reach and purpose has grown beyond updating an individual’s status to a tool to communicate with potential customers. You can even like the FDA on Facebook. (For some Life Sciences manufacturers, there is a tinge of an oxymoron there.)
Continue reading "Product Communications Using Social Media - Like this…or Not"
We would all like the questions to a test ahead of time.
But unfortunately, an FDA audit doesn’t work that way. The FDA inspects many facilities every year across the spectrum of product types. So how do they determine how to get through this mountainous list? Manufactures have to register with the FDA and provide a list of products that they make. Different products have different risks-an implantable is different from a toothbrush. Those products with a higher risk have a greater need for an inspection.
They will look at reportable records and recalls not only for severity but frequency as well. Consumers or healthcare providers complain directly to the agency as well. This will draw attention to you. The newness of a device will also contribute to putting you on the list.
Continue reading "FDA Audit GPS"
Join us at AXUG Summit 2014 for our session, Risks, Warning Signs, and Best Practices for Stabilizing Your Microsoft Dynamics AX Project.
Enterprise Microsoft Dynamics AX projects face a number of risks and challenges due to the transformational impact they have on companies. And recently we’ve seen an increase in the number of companies who receive limited value from their investment into Microsoft Dynamics AX because the system was not implemented correctly - or hasn't even been implemented at all! Join us for this session as we discuss the major risks associated with Microsoft Dynamics AX enterprise projects, how to identify the warning signs that your project is under stress, and ways you can stabilize, turnaround, and optimize your enterprise platform
This session takes place Thursday, October 16th from 3:15 - 4:15pm in Room 105.
Merit Solutions is proud to have the opportunity to present the following session at AXUG Summit: Business Transformation for Life: Thinking about Implementing Dynamics AX (and related systems) with Long-term Support in Mind
This session is takes place on Wednesday, October 15 from 1:00 - 2:00 pm in Room 102. The session is built around why it is important to consider ongoing usage/support/maintenance of a system from the start. At each phases (Analysis, Planning, Implementation, Go-Live…) there are different things that should be taken into consideration regarding ongoing plans once the project is live. Making those decisions up front is critical to uncover gaps, avoid poor adoption, insure that company gets the most out of their investment ongoing. This session will highlight these important items with a nice analogy to family life:
- The Analysis phase is like finding your partner (system choice)– You should know why you are choosing AX and ensure that your goals are in sync.
- The Planning phase is like thinking about what your family (implementation) might look like - including how many kids, cars, size of house needed, type of schooling, etc... (This relates to 3rd party add-ons, architecture, consulting/training/support.)
- The Implementation phase starts off fun (cute babies and everyone is excited) and there is typically a lot of help available.
- The Implementation phase then becomes challenging/overwhelming (when kids head off to school and have a lot of activities to balance).
- Then the Implementation phase becomes hell - you have moody teenagers ready to graduate and head off to college, while, at some point, everyone hates everyone!
- Finally we reach the Go-Live phase where everyone leaves and you are on your own.
Don't miss the chance to hear how all these things relate!
AXUG Summit is rapidly approaching and Merit Solutions is excited to be an exhibitor and presenter at this year's conference!
We are especially please to announce the Life Sciences track at AXUG Summit this year, with Merit Solutions and Valarie King-Bailey covering a wide range of topics relevant to Microsoft Dynamics AX Life Sciences companies.
Here are the four AX Life Sciences track sessions:
- Microsoft Dynamics AX and the Sunshine Act: Fits, Gaps, and Real-World Applications - Thursday, October 16 from 4:45 - 6:00pm in Room 105
Physician Payment Sunshine Act requires all medical drug, device, and
supply companies to report how much they spend with individual
healthcare practitioners. This has caused an immense amount of activity
for these Life Sciences companies because aggregating healthcare
practitioner spend data is growing rapidly in terms of complexity and
global adoption. In this session, we will discuss real-world
applications of the Sunshine Act using Microsoft Dynamics AX – while
diving into the fits, gaps, and solutions for complying with regulations
and mitigating the risk associated with these investments.
- UDI, DSCSA, and Microsoft Dynamics AX - Thursday, October 16 from 2:00 - 3:00pm in Room 102
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. 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.
Valarie King-Bailey (OnShore Technology)
- AX Validation Approaches: Maintaining the Validation State in a Cloud Computing Environment - Wednesday, October 15 from 1:00 - 2:00pm in Room 125
This session will be a deep-dive and practical overview by subject matter experts with a focus on real life business challenges and solutions to help provide you with a thorough understanding of the software validation process as it relates to Microsoft Dynamics AX. This session will cover IQ/OQ/PQ and GAMP 5 applicability to the AX validation process. This session will also cover resource requirements, automated validation testing, maintaining the validated state and much more.
- Green Validation: Paperless Validation Strategies For Microsoft Dynamics AX
- Thursday, October 16 from 8:00 - 9:00am in Room 224
Is paperless validation a reality? This session will cover the following topics regarding Dynamics AX validation: How you can initiate the validation activities early in an AX project; eliminate paper documentation and slow approval processes; reduce by 50% the time to completion by automating tasks, and maintain your AX systems in a validated state and inspection readiness. ⁞
Please join us for these great sessions - or stop by and see us in Booth 1301.
A robust CAPA system is sustained by sub systems that provide feedback into CAPA. There should be appropriate mechanisms in place to facilitate this flow of data. This is not a static system but rather a continuous loop. The risk becomes apparent when the CAPA loop remains unclosed. The result may be a CAPA that is opened for years or a CAPA that really didn’t fix the problem. The goal of continuing to collect data is to reduce the number of issues encountered as well as the severity of those that do occur.
Continue reading "The Care and Feeding of a CAPA System"
Organizations of every kind want to get lean. Adding value, eliminating waste, and automating are some current buzzwords. ERP, on the other hand, is sometimes considered a necessary evil or even a creator of waste. But these two disciplines can get along quite nicely as complementary tools in our toolbox.
The best definitions of lean consider it to be an endless cycle. We identify value and define it in terms of value to our customer. We map the value stream; we identify all the activities that create value and place them along the stream of our processes. We create flows where our products and services move easily from one step to the next. We establish pulls; nothing is completed and passed along the stream until the downstream operation is ready to receive. We seek perfection, practicing every step until it is automatic and eliminating any unnecessary steps. Then we do it all over again.
Continue reading "Getting Lean with ERP"