How Regulated OEMs Modernize Inventory Control and Traceability Reporting with Optimized ERP Systems

OEM medical device and life science companies have specific documentation demands that go above and beyond routine business reporting and tracking. For many years it was managed with mundane paper filing systems stored in bulky cabinets that were reliant on manual, antiquated filing habits. Yet the ever-advancing digital age has renovated how we store such information. Enterprise resource planning (ERP) systems were created to digitally store critical data and make it more reliable and easily accessible than those old paper trails ever were – providing the traceability and inventory control that was needed to successfully meet strict compliance requirements.

Medical device industry ERP benefits

Highly regulated industries like medtech have benefited from ERP systems that can meet specialized regulatory and compliance needs while increasing efficiencies across operations, warehousing, and fulfillment. Companies can say goodbye to the old-fashioned paper trail (and resulting compliance risks) and say hello to a full-suite, online system that streamlines delivery and generates some of the most critical and difficult data points and documents in your entire business process – becoming the traceability tool you need to support scalable growth and organizational success.

Identifying your priorities, budget, scalability, and available time for training and adoption are key when considering a new ERP solution. The following are four reasons now is the time to make your move to a full-suite ERP system:

A modern solution An ERP system is a centralized, digital hub that protects your manufacturing data, prevents errors, and fends off recall or quality issues. It can manage everything from sales and quoting to inventory management, document management, shop floor control, quality management, and financial accounting. Advanced security measures protect information with sophisticated user access controls and high-level encryption to protect sensitive data.

Simple training With a system like Cetec ERP, companies gain an out-of-the-box technological tool that is immediately ready for use. The user-friendly interface allows employees to quickly learn and navigate the platform – enabling your team to rapidly adopt and deploy to reap the benefits for your OEM manufacturing business.

Scalability priorities Anticipating scalability issues as you grow is the best way to avoid them. With the right ERP solution, you can easily adapt and accommodate new modules as needed to meet imminent growth demands without additional administrative overload.

Regulated industries As a highly regulated industry, the medical device sector is required to maintain rigorous records to meet ISO standards and FDA compliance. The right ERP system integrates compliance checks and quality control procedures into your manufacturing and distribution processes to help consistently record and preserve them.

Medical device manufacturing ERP traceability

Medical device companies should select an ERP system that was designed to support companies in regulated industries and offers end-to-end lot and serial traceability – from raw materials to subassemblies to finished products shipped to the customer. Cetec ERP’s ironclad traceability reporting is streamlined to help maintain reliable traceability and increase efficiencies for more dependable reporting and to save time.

Your ERP system should have the following traceability benefits and functionalities to meet all your current needs while supporting future scalability:

Raw materials

  • Ability for raw material traceability to be tied back to a specific PO line receipt with a CoC/CoA and connected to a receiving/incoming inspection.
  • Able to track the entire life cycle of that lot, traversing subassemblies all the way through to the finished goods shipped to a customer.
  • Documentation storage for quick reporting and easy lookup for auditors or for recalls. Accurate picking/allocation of material with FIFO methods and barcode scanning of receipts.

BOM lot codes and serials

  • Generate lot codes for subassemblies or finished goods for your customers; ability to generate a serial number and print a UDI label to track history, rework or repair for warranty, and more.
  • Provide a traceability document linking every lot code used in the product, all the way down to the raw materials – eliminating those large paper packets and physical paper tracking by storing all the data within the ERP system.

Systems like Cetec ERP offer all this functionality and more, becoming a vital tool to modernize medical device companies by streamlining operations, improving compliance and digitizing traceability.

Regulated industries have evolved to achieve more effective documentation methods that meet compliance requirements thanks to revolutionary ERP technology with traceability reliability and data access. Gone are the days when towering cabinets of paperwork took up office space and created compliance risks with their inefficient filing systems and manual limited access. Today, companies can store all their data in a digital ERP solution, accessible from anywhere, with all the operations details, raw materials and BOM lot codes and serials you need to successfully manage and scale the business.

Learn more about the Cetec ERP system and how it can modernize your inventory control and benefit your traceability

Looking for more information on ERP functionality? Read Lot/Serial Control for UDI & MDR Compliance and Soup-to-Nuts Lot Traceability.