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Medical Device Reporting - Getting it Right

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.

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Risk Management for Life

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"

Innovation is Everywhere and Anywhere

Miriam and Gerry are receiving clerks. They are no different from millions of us who work hard and are underpaid. Their job only has visibility when something has gone wrong. Many days they will work hard all day and none of the higher-ups even know they were at work.

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ERP Quality Control: 5 Common Wrenches in the Works

Just about any of today’s ERP systems will have a quality management component included. Set up properly, they provide a source of data to satisfy the needs of your business and the needs of your customers. But used incorrectly, an ERP quality module can throw a wrench into the works.

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Android App Localization Using Xamarin Forms and resx

If you are developing Android mobile applications, chances are that you are going to need some kind of localization and internationalization. And if you are targeting multiple mobile platforms - you would most likely prefer to do that job in one place.

The use of Xamarin Forms, PCL projects and paradigms such as MVVM allow for a great code sharing between all the different platform projects. Ideally our solution for localization:

  • Should be based on resource files
  • Resource files should be maintained in only one project

Here is when resx files come into the game. Resx is very simple and powerful resource management solution, where you can add or remove string, image, audio and video effortlessly.

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Another Look at the Future of ERP

Hello, I am Fred. I have worked here at XYZ Company a long time. Will and I started the same day. Will says the new ERP has made his work in welding more efficient and helps eliminate mistakes that caused people from accounting to visit and ask why he used some part he has never seen. I like it too. I think I am more efficient now but what I really like is that I can connect from anywhere and no matter when, I can save my thoughts and actions right to the system.

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Excellence By Design

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.

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Job Management in Manufacturing

Jobs are a basic concept in the setup of ERP systems for many businesses. We often think of a job as a batch of production in a small “job shop” kind of business but job is a much bigger concept. It might be a batch of production for a particular customer order. It also can be a small batch of production to put a handful of product on the shelf for sale. It can be a million basketballs made over months for next Christmas sales. A job can be a project to develop software or the construction of a hotel building.

Job is simply a word we use to collect physical production and the related data. Some might call it a work order or a production order and surely there are other words.

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Product Communications Using Social Media - Like this…or Not

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.)

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Tomorrow's Manufacturing ERP

Good morning. My name is Will and the boss asked me to say a little about our new manufacturing ERP system. Since I started working here at XYZ Manufacturing in 1985 we have changed or upgraded our internal systems a couple of times. This is the first one that really made a difference where I work - in welding. I guess the others helped in the office but mostly that did not affect me.

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