Getting a new product into the customers hands as quickly as possible is critical to medical device manufacturers. Perhaps during the rush to hand off a product to the manufacturing floor, corners are cut. The end result can be manufacturing delays that prevent the product from going out the door - or even defective product reaching the customer.
Paying attention to the details up-front can save time in the long run. Resolving issues early in the process lends itself to a seamless transfer in house or to a contract manufacturer.
Continue reading "Device Design Transfer - A Smooth Hand-off"
A little over a year ago, the FDA issued a draft guidance document (Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection) regarding the types of actions that would be considered to obstruct an FDA inspection and potentially lead to a supposition of adulteration. Last month, the final guidance was issued. The document attempts to define what behaviors are considered to mean an intentional delay or refusal. The FDA has the authority to enter any facility under the jurisdiction of the FD&C Act at reasonable times and conduct inspections.
Continue reading "Not Obstructing the FDA - Be Reasonable"
The purpose of MDR reporting is to provide a means to collect data that may indicate the presence of a safety problem. MDR reporting can be confusing and it is certainly an area where mistakes are abundant. Some mistakes however will garner more scrutiny from the FDA. In extreme instances incorrect reporting or lack of appropriate reporting can lead to criminal charges.
Continue reading "MDR Perils –Avoiding Entanglement"
When questioned if their company has a focus on quality, most managers and employees will say yes. This might be because at a minimum, it is the right thing to say. They may also believe that since they have some procedures or a quality policy that this suffices and that quality practices will just fall in to line. Under further scrutiny, however the differences between perception and reality become apparent.
The view from higher levels in the company may be that it has a well disseminated quality culture. But as you travel down the organization chart, the response may not be so positive. A culture of quality is a full time commitment to quality. It is not just referencing standards in a few SOPs. Everyone should understand who the customer is and what they expect.
Continue reading "Building a Culture of Quality- More Than Words Can Say"
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"
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.