When many people learn about Enterprise Resource Planning (ERP) system, they think about manufacturing furniture, electronics, or even food products. All of these industries benefit from the enhanced communications, automation, and cross-departmental process-streamlining of a cloud ERP, but it's the medical device industry that may benefit in the most significant ways.
As one of the most highly-regulated industries in the U.S., the medical equipment industry has precise and unyielding software requirements and business needs. Failure of any sort can be costly, especially when it involves product recalls and litigation. Read on to learn more about ERP, and how a cloud-based NetSuite ERP supports medical equipment manufacturers.
What Is ERP?
Enterprise Resource Planning (ERP) is an integrated and unified approach to managing company resources, processes, and communication across departments and the supply chain. These may include but aren't limited to:
- Human Resources
- Customer Care
- Quality Assurance
The term was first used by the Gartner consulting firm to describe a more productive, streamlined, data-driven way to do business. When we talk about ERP for medical device manufacturers, we're referring to a single, centralized piece of technology that helps leadership manage processes and communication while gathering usable business intelligence to continually improve those processes. ERP gives administration the control and insights they need to compete in the highly-regulated industry of medical equipment manufacturing.
1. Meet & Exceed FDA Software Validation Requirements
First, and perhaps most importantly, the Food and Drug Administration (FDA) provides guidelines regarding the validation of software involved in the manufacturing of medical equipment to ensure that the software supports business needs for quality, consistency, and compliance throughout the process. This includes both the software itself, which must meet or exceed FDA standards, as well as the systems an equipment manufacturer has in place to ensure that their software continues to meet business needs year after year. The FDA doesn't go as far as to tell a business how to accomplish this, as each business is unique. Still, it's safe to say that a regular review of medical equipment guidelines and the ability of existing software to comply is in order.
A cloud-based NetSuite ERP exceeds FDA standards and can be configured to meet specific business needs.
2. Scale and Adapt Easily
A cloud ERP is also adaptable and scalable, so as FDA and other regulatory requirements change, you have the technology to evolve with them. With advancements in cloud-based technologies, companies no longer have to go back to the drawing board every five to 10 years to overhaul their premises-based ERP or software completely. As technology advances, so does a cloud ERP.
3. Meet & Exceed Other Quality Standards
Whether a company is producing wheelchairs, insulin pumps, or oxygen concentrators, it must always be mindful of regulations and standards like ISO 9001 and 13485. The NetSuite ERP can help you track compliance changes, quality issues in the supply chain, and more to accomplish this.
4. Secure Electronic Sign-Off and Audit Trail
The NetSuite ERP makes tracking inspections and signatures for a complete and compliant audit trail straightforward, and because an ERP is centralized, whether it’s legal, shipping, or vendor management that needs those signatures, they're accessible all in one place. ERP provides a centralized, customizable, enterprise-wide tool that can make even the most mundane or hard-to-track tasks easier.
5. Get Rid of Time-Consuming, Tree-Wasting Paper Systems
Paper tracking systems had their place at one time. They allowed employees to update records on the manufacturing floor or elsewhere in the building when they weren't near their work station. But with 2020 and beyond mobile-first technology built right into the ERP, people can access and update information from anywhere and communicate with each other directly using secure, authorized mobile devices.
6. Automatic Cross-Departmental Communication
A NetSuite ERP allows each department and job title to access and update information based upon their job role and security level, but it can also communicate that information to related departments, apply it to various associated databases and forms, and notify management of issues or bottlenecks to improve productivity throughout an organization.
7. Real-Time Insights
Because of features like centralization, cross-departmental electronic communication, mobile-first technology, and Internet of Things (IoT) integration, leadership has real-time data on which to make the most informed decisions for the organization.
8. Integrated CAPA Functionality
A NetSuite ERP supports Corrective Action & Preventive Action plans that you have in place. Whether you've faced penalties in the past and need to take extra steps to prove compliance or you need the systems to prevent legal and compliance issues in the first place, an ERP is designed to meet medical device manufacturer’s industry-specific and business-specific needs.
9. Manage Supplier and Vendor Relationships
What is ERP doing for medical equipment manufacturers? It not only improves communication and processes within the organization, but a NetSuite ERP can strengthen communication and partnerships with third-parties who make device manufacturing possible as well.
10. Lot and Serial Number Tracking
A NetSuite ERP can trace and track lot numbers, serial numbers, warranty, and servicing dates to further both compliance and your understanding of equipment lifecycle, quality challenges, and more.
Setting Up NetSuite ERP for Medical Device Manufacturers
ManoByte helps medical device manufacturers embrace the digital transformation by enhancing their communications, processes, and business intelligence through the power of NetSuite ERP and other technology platforms. We assess unique business needs to develop custom solutions, and then we train your teams to get the most out of ERP as well as providing the ongoing support you need to succeed with ERP.
To learn more about ERP of Medical Device Manufacturing, let's connect.