Manufacturers in the medical device industry are obsessed with quality. Much of this is forced on the industry with constantly changing regulatory and government-mandated requirements. Beyond that, internal and customer-specific quality requirements extend from vendor supplied materials and services to work-in-process to finished goods’ inventories. The burdens of the industry includes on-going changes in production techniques, emerging innovations in components, technology and materials that drive continual product evolution, along with customer specific packaging and labeling requirements. Tracking material certifications of specific components used in any product to support downstream compliance and service needs just adds to the challenges. In many cases, the solution to these challenges includes tedious and time-consuming manual effort along with extensive paperwork and fragmented product documentation.
We know the future of your industry and your internal ability to overcome its challenges depends on automation. With Infor SyteLine ERP (CloudSuite Industrial), the future is now.
Whatever medical devices you may be manufacturing …
- Cardiology Monitoring Equipment
- Healthcare Products
- Clinical Research Technology
- Institutional, Assisted Living, Medical Care Furniture and Fixtures
- Testing Equipment and Devices
- Medical Device Components, both Mechanical and Electronic
- Wiring / Wiring Apparatus and Cable Assemblies
- Magnetic Imaging and Radiation Treatment Equipment
- 3D Printing Technology
- And more
Infor SyteLine has you covered …
- Medical Device Reporting — Maintaining and tracking in accordance with FDA Compliance, including Medical Device Quality Systems (QS), Electronic Device History Records (EDHR) and Unique Device Identifier (UDI).
- Mobile Information Access — Mobile Access puts key functions on your mobile device for various user roles within SyteLine. This allows your staff to be productive when away from the office, with the use of their cell phone. Checking in on information from multiple sites is available for roles like Executives, Controllers, Operations Managers, Salespeople and even IT Staff.
- Roll-forward Personalization — Change the look and behavior of screens and forms without impacting source code. This provides you the ability to adapt SyteLine where required to provide not only a functional fit but more importantly to achieve a Business Process fit. These changes are automatically migrated forward in conjunction with patches and upgrades to the base product.
- Field Assembly / Installation Support — Some manufacturers deal with products that are sent to the customer for assembly & installation by field service staff. SyteLine easily supports this need with mobile access and updates with everything needed by field workers to complete their work. That includes drawings, manuals, technical specifications and more.
- 360° Customer Management — Manage all aspects of your relationships with customers and prospects, from estimating to invoicing to service management.
- Materials and Inventory Management — Buy what you need, when you need it. Do away with side systems, which are difficult and costly to maintain. Shorten order entry time, eliminate duplicate orders, cut down on costly data entry errors, and make sure data is consistent — leaving you with more time to work on activities that grow your business.
- Application Event Automation — Customize your system without modifying your source code, and improve your workflow in the process. When you upgrade your system, you’ll automatically upgrade your customizations at the same time.
- Advanced Planning and Scheduling (APS) — Find out if you have the materials, people, machines, and tools you need to manufacture an item.
- Service and Warranty Management — Installation and repair service orders, time and expense tracking, cost management and billing. Service Contract administration including billing rates and options. Warranty tracking with complete component history for as built, as sold and as-is. Plant Maintenance including automated maintenance scheduling.
- Manufacturer’s Part Numbers — SyteLine items can have multiple manufacturers’ items that can be ranked with controlled use.
- Forecasting — Determine the right amount of raw materials and components needed to meet production requirements. Automate the calculation of forecasts and other inventory drivers, such as safety stock. Alerts notify you when actual demand varies from the plan.
- Program/Contract Management — Complete Project based manufacturing capabilities that combine the production, scheduling, engineering, logistics, financial, and project management tools users need to manage complex project requirements, long lead times, and strict cost controls.
- Document Management & Automation — Complete management of all documentation: emails, email attachments, CAD drawings, scanned documents, outbound documents, purchase orders, invoices, estimates, and more. Document Book functionality pulls all related documentation for any manufacturing job through assemblies and all the way back to purchased materials—including certification documentation.
- Hybrid Manufacturing — Any combination of engineer-to-order, configure-to-order, make-to-order, assemble-to-order, make-to-stock, Kanban and repetitive needs.
- Kitting — Allows a number of components to be bundled in a pack from a sales order perspective. On the picking list / packing slip, the sales order “kit” item is printed together with the indented components that are embedded inside that “kit” item.
- Labor Collection / Time & Attendance — Touch screen labor recording, production status, real-time dispatching, production recording, material issues, lot & serial recording, time & attendance and manufacturing document automation.
- Lean Manufacturing — Including Kanban replenishments, back flushing of materials, labor & machine time, and rapid recording of production information- with or without labor recording.
- Business Intelligence & Dashboards — Simple-to-use tools for decision-making and analysis. Dashboards are dynamic and up-to-the-minute.
- Intelligent Lot & Serial Numbers — Each item / part can have its own set of serial numbers. That includes their own uniquely formatted, intelligent serial number.
- Complete Project, Job and Product Costing — The Cost Accounting features within SyteLine support both actual costing and standard costing, providing you with the flexibility to choose the Cost Type and Cost Method that works best for each specific product. SyteLine automatically charges work order costs for customer orders to the Cost of Goods Sold upon shipment to the customer.
- Collaborative Design & Engineering — From a simple CAD interface, to more functional Product Data Management, and even more sophisticated Collaborative Design & Engineering PLM functionality. SyteLine spans multiple locations and keeps your team working efficiently together.
- Engineering Change Control — Control and track revisions made to a Bill of Materials or to the routing of an item. When it is critical to ensure high quality, safety and consistency of products, the ECN process is crucial.
- Manufacturing Execution — Top manufacturers have a new secret weapon with SyteLine Manufacturing Execution Systems (MES). Real success in manufacturing requires a great planning system like SyteLine and an equally great shop floor execution system. Multiple systems on the shop floor as well as paper-based reporting and schedules simply can’t keep a modern manufacturing workforce like yours operating at peak efficiency. Utilizing touch screen technology along with drag & drop capabilities, you will accelerate and simplify shop floor operations while garnering excellent user acceptance.
- Role-based Home Pages — No more confusing, multiple layer menus. Access everything you need with one click from one screen. Save time, be more efficient and less stressed. Everything you need is brought to you instead of you searching endlessly for it.
- Personalized User Experiences — Personalize your user interface (UI) to fit the unique needs of your company, team, or even you as an individual user. Add, remove, and move fields and labels without having to call on IT for help. Get the information you need, when you need it.
- Integrated Accounting & Financial Management — Every task performed in SyteLine that requires a financial transaction is integrated to the solution’s own accounting and financial management applications. From inventory and production transactions to shipping, invoicing, field service and more — they all flow seamlessly into accounting. View cash impact information that incorporates all anticipated sources and uses of cash. From unshipped orders to invoices, outstanding purchase orders, A/R and A/P transactions as well as current cash balances. A simple time phased snapshot of cash available on demand.
- Compliance Management — Management of compliance and certification documentation as well as certification requirements, like RoHS.
- Single or Multi-Site Operations — SyteLine allows your companies to work together or separate based on your needs. A “site” or organization / company represents any place where work is done. A site may correspond to company headquarters, a manufacturing plant, or a distribution center. SyteLine automates intercompany operations where sites supply each other with products or services.
- Product Configuration — Simplify the most complex configuration requirement for Engineer-to-Order products that require rules-based, parametric configuration capabilities, as well as less complex features / options requirements to support your Configure-to-Order situations.
- Mongoose Rapid Application System — Infor Mongoose is an application development framework that lets you easily design and deploy applications that enhance your core enterprise solution. When needed, you’ll be able to create enhancements in a fraction of the time and with far less effort than is required with traditional development approaches.
- Product Genealogy — Traceability of components and material, along with related information. Trace lot numbers, serial numbers and compliance documentation, from material receipt all the way to the finished product.
- Quality Management — Quality control for incoming goods, outgoing shipments and in-process production quality checking.
Infor SyteLine ERP (CloudSuite Industrial) has your back with real-time data to support production, back office operations, device histories, and product costing. SyteLine is a comprehensive software solution. It includes everything from sales, accounting, manufacturing, inventory control, and quality assurance capabilities are vital for companies like you to succeed in this industry.
Your company can track the movement of materials and parts from receipt to shipping, ensuring that products meet or exceed the standards required by customers and by regulatory agencies. SyteLine allows you to access information quickly for informed decision-making. Manage costs, monitor business processes and have complete compliance information at your fingertips. Lean manufacturing features ensure you deliver on-time while the integrated quality management system helps you easily collect, control, and analyze product data. Give us a call at (920)406-3030 and we can show you how The Lake Companies and Infor SyteLine (CloudSuite Industrial) can help you overcome your challenges with speed and simplicity.