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
- 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
- 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
When reviewing software for your manufacturing company keep the following in mind:
- Does it have cradle to grave lot tracking? Keep in mind that 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. See my article on Serial, Lot Tracking and Traceability for Manufacturers.
- Can the software run a lot recall report in a matter of seconds?
- Will the 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 the 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 the 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.
If you care to comment on the information above or have any questions please feel free to contact me at [email protected].
by Custom Information Services,