No doubt, all manufacturers must grapple with issues such as compliance, inventory management, traceability, cost control, and collaboration. But let’s face it, if you’re a medical device manufacturer, your challenges are on another level. People’s lives depend on your product, and your product depends on your safe handling of it from the design and prototype phase all the way to customer service. That’s why your ERP system is so connected to the vitality of your company; like a pacemaker, it keeps your company pumping at an optimal rate. Don’t have an ERP? Have one, but desperately in need of an upgrade? Then read on to find out why cloud-based ERP systems are breathing life back into medical device manufacturing companies that were once suffocating under the pressures and regulations of producing and delivering high-quality devices.
In this upcoming series, we’ll delve into the biggest challenges facing medical device manufacturers and how ERP systems can face and easily overcome them. First up: the biggest beast in the woods—regulatory compliance. The one constant in regulatory compliance is that it’s always changing. Adhering to these changing regulations from the FDA (and even the EMA) can be like playing a game of Whack-a-Mole: knock out current compliance standards and new ones pop up. A cloud-based ERP system and validation protocols will optimize your manufacturing and reporting processes as well as fight your headaches of staying in compliance along the way. Below are a few standards and regulations common to the Medical Device manufacturing industry that ERP systems are equipped to manage.
Quality Control Tracking of Your Product (Meeting regulations ISO 13485, 21 CFR 11 and 21 CFR 820):
A robust quality control system ensures your product not only exceeds the FDA’s regulatory demands but also exceeds the demands the healthcare industry requires to bring safe and effective treatment to their patients. Some ERP systems ensure devices are consistently designed and produced to meet predetermined specifications. And that’s great for the now, but what about the future? Your ERP system should also generate data that allows you to identify areas in your design, materials and processes to enhance the quality and performance of your devices over time. Your commitment to the quality of your products not only facilitates compliance but also enhances your customers’ trust. A modern ERP system will assist you in maintaining the verification and validation to meet Good Manufacturing Practice (GMP).
Quality Control Tracking of Your Employees (Meeting sub-regulations 21 CRF 820.25, 820.25b and 820.26):
Your product isn’t the only item requiring oversight by the FDA; your employees are monitored as well. The FDA demands that your personnel correctly perform all activities involved in the manufacturing process. This regulation ensures that personnel have sufficient education, training, and experience to adequately perform their assigned duties, and that you have it all meticulously documented, all of which adds yet another layer of record-keeping and tracking to your job and validation efforts. ERP systems, within their human resource (HR) modules, help manufacturers remain in compliance by tracking the skills and training of staff, thus reducing human input error in a strictly controlled environment.
Risk Management Processes (ISO 14971):
The FDA requires medical manufacturers to address potential risks throughout the device’s lifecycle, from concept and design to post-market surveillance and maintenance. ERP systems provide risk management processes and protocols that help manufacturers identify, access and solve malfunctions and defects associated with their products before they reach the market. These quality and risk processes help analyze and evaluate defects and provide the controls you require to resolve them. Your systems should also be able to generate and update a benefit-risk analysis, a risk management plan, and a post-market surveillance process. In addition to these requirements, manufacturers must keep strict documentation of all processes and activities and have them readily available for regulatory authorities and auditors to validate them.
Overall, regulatory compliance eats into a hefty percentage of your daily workload. By updating your current ERP system or upgrading to a cloud-based one, you will have at your fingertips an indispensable tool to considerably reduce that percentage. Because, ultimately, manufacturers agree these regulations are a necessary part of producing the best quality product in an industry that not only improves the quality of people’s lives but in many cases, saves them.