Addressing FDA CFR Regulation Compliance with Cloud based ERP Software

  • September 18, 2014
  • Feature

Bill Nolan, Midwest Representative, Rootstock Software      September 18, 2014 - Most current Good Manufacturing Practices (cGMP) are regulated by the FDA under the Code of Federal Regulations (CFR) 21 CFR. These apply to food, pharmaceutical and medical device manufacturers. Companies working in such 21 CFR regulated industries are well aware of how important compliance is. They are required to self-certify their own products to be compliant with an applicable standard, based on a quality control testing program. If not, they face consequences. A public company can see their valuation distressed along with increased liability for management and board members. Private company owners may be personally liable for financial penalties. The bad news is that many regulated manufacturers use paper- or Excel-based processes to address compliance. These systems are functional and meet government requirements but they often consume disproportionate time and resources while being prone to error. The food, dietary supplements and medical device industries are areas where significant improvements can be made by replacing a traditional paper-based system with a contemporary Cloud ERP application. Moving from paper-based to digital compliance processes helps avoid errors while saving time and money. Importantly, for discrete manufacturers who are required to have FDA CFR compliance, the Force platform offers some distinct advantages. First, though, let's quickly review some of these regulations - 21CFR Parts 110, 111- Food and Supplements - These cGMP regulations affect the food and supplements industries. 21 CFR Part 110 deals largely with food sanitation, food handling and food preparation issues. Part 110 Current Good Manufacturing Practice (cGMP) covers facilities, equipment, production control and actions to address defects in the manufacture of food products. Lastly, Part 111 expands on 110.  It requires the same as cGMP 110 but affects the dietary supplement industry and deals with the manufacturing, processing and holding of these substances. Although dietary supplements are regulated by the FDA as foods, it is important to note that they are regulated differently from other foods and from drugs. In addition to establishing a production and process control system, there are requirements for quality control. All components for packaging and labels as well as product that is received for packaging or labeling as a dietary supplement must be tracked. Records must be kept regarding batch production, laboratory operations and the storage and distribution of products. In addition, supplement manufacturers must be able to show a formal returned dietary supplements (RMA) process and tracking of customer complaints regarding their products. 21CFR Part 820- Medical Devices - Another area of compliance that is easily addressed in a Cloud ERP Solution is FDA 21 CFR Part 820, Medical Device manufacturing.  This cGMP regulation effects the medical equipment and medical devices industry. In addition to the general provisions that are similar to Parts 110-111, compliance with 820 requires quality system information tracking, engineering change notice (ECN) functionality, document tracking, purchasing traceability, tracking of acceptance activities and tracking of nonconforming products. All corrective and preventive actions must be recorded.  Labeling and packaging need to be tracked. RMA functionality and the ability to record statistics related to product returns are also required. Compliance through Using Software It is important to focus on the fact that it is the compliance process that is certified, not the software that supports it. Software is treated as a tool that is used the same way a paper based system is to record and support the compliance process.  However, a cloud based ERP software system makes the process faster, easier and less prone to error. For example, an ERP system such as Rootstock that is native to the Force platform will allow for a “best of breed” approach to adding such functionality.  Additionally, the need for electronic signatures and to have a handwritten signature executed to electronic records can be easily accomplished with an application like DocuSign. This is because the Force platform lets users take advantage of mobile functionality to record and retrieve data relevant to compliance from anywhere they have access to a web browser. This is particularly for gathering information about remote manufacturing facilities and RMAs. Force users can build Communities (private portals) to share information with their vendors and suppliers regarding compliance. As a result, everyone receives a “real time” view and issues are addressed immediately. In addition, the reporting functionality of the Force platform provides a myriad of ways to present compliance data so that reports are presented specific to the audiences they are intended for government inspectors, Board members or employees. Another powerful utility of the Force platform is Chatter, a messaging function that lets users communicate. The software will also send messages (Chats) to predetermined people when it senses an issue around compliance. Moving from Paper to Digital Compliance An AppExchange ERP software system such as Rootstock provides all the functionality necessary to comply with 21CFR 110,111 and 820. It has application such as lot trace, serialization, assembly tracking, ECN, RMA and product history. To take advantage of the gains that such a software solution will bring to compliance based manufacturing environment, it is important to move from paper to digital in a structured fashion.   During the course of software implementation, the ERP vendor should be involved in all areas of the manufacturing process. Regarding compliance, the customer should drive the procedure but the ERP vendor will offer direction. For risk management, it will be best to keep the paper-based method in place to meet FDA requirements while setting up and training the users on the digital system. The new enterprise resource planning system will show short term business benefits while compliance paybacks will come over time. Depending on the complexity of the products (how many levels to the BOM), this could take a few months. Before switching over, there should be time to run simulations to assure compliance. Using an ERP application to pass an audit in less time with fewer errors will be an accomplishment for the firm making the switch to digital, but only if they  remember that “The Process is Certified, not the Software."


Bill Nolan is Midwest Manager for Rootstock Software, a Cloud based ERP solutionbuilt and deployed on the Salesforce1 platform. The company’s manufacturing, distribution and supply chain apps provide ERP integration “out of the box” with Sales Cloud by and other ERP-centric applications written on the Salesforce1 platform. Rootstock is available on the AppExchange by

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