Manufacturing Software FDA Approved
Posted Thursday, September 1, 2011 by Don Kapuscinski
I have been asked many times over the years if manufacturing or ERP software was FDA approved. Based on my experience in the manufacturing industry, ERP software is not FDA approved, but rather can be utilized to follow and maintain your company’s processes to be compliant with the Current Good Manufacturing Practice (CGMP). If you are a manufacturer you are probably already aware of what the FDA does
* foods, except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture * food additives * infant formulas * dietary supplements * human drugs * vaccines, blood products, and other biologics * medical devices, from simple items like tongue depressors, to complex technologies such as heart pacemakers * electronic products that give off radiation, such as microwave ovens and X-ray equipment * cosmetics * feed, drugs, and devices used in pets, farm animals, and other animals * tobacco products
Small and mid-sized companies have the same FDA requirements as large companies but with significantly fewer resources. Luckily there are software packages for the small to mid-sized manufacture that can help with compliance such as Microsoft Dynamics GP and Vicinity Manufacturing. Keep the following in mind:
* Does your current system have cradle to grave lot tracking? Garbage into your system will get you garbage out. Lot tracking within a computer system is difficult even for the most disciplined companies. Perhaps you could start tracking a couple of your highest volume raw materials and finished goods, and then add more as you get your processes worked out. Of course, keep another record of your lot numbers during this process.
* Can your current software run a lot recall report in a matter of seconds?
* Will your current software handle bar-coding for receiving, shipping and production? Your company may not be ready for the handheld expense of bar-coding and a wireless network, however you may want to add this in the future. Make sure your system can handle this feature along with RFID.
* Does your current software have a strong quality control module? Can you record QC results throughout the manufacturing process including receiving the raw materials?
* Can you print nutrition labels, certificate of analysis (COA), or Material Data Safety Sheets (MSDS) that are data driven by your recipe or formula manufacturing?
* Can your current software store and track results by batch for our HACCP guidelines and compliance?
* Are the formulas and recipes secured to make sure production manufactures only approved products?
* Is there electronic audit tracking available and electronic signatures?
These items are just a few compliance requirements that I can think of for food and cosmetic manufacturers.
MRP Consulting has become the largest Dynamics GP Manufacturing partner in North America. We have worked with over 600 companies Worldwide and are available, at ZERO cost to you, for a 1-day onsite visit in which we will map out your current processes and measure them again your current systems. Sometimes a “tune-up” is all that is needed to keep your business running as it should. We can all agree that having the right software will not only improve internal processes and productivity, but will also improve customer relationships.
Give us a call today.