In this series targeted especially for Medical Device Manufacturers (MDMs), we’ve delved into the biggest challenges facing your industry and how ERP systems can meet those challenges. Last up: Traceability. Simply stated: In a highly regulated industry, such as medical device manufacturing, traceability is crucial. Knowing the entire history of your product or products from design to production to implementation will ultimately save you from minor tension headaches to major migraines. By upgrading to, or implementing, a modern ERP System to manage your critical processes, you can easily overcome four major traceability challenges:

Traceability Challenge 1: Lot and Serial Number Tracking
With serial number tracking, every product becomes unique, and every journey becomes traceable from raw materials to the finished product. Nothing can be more headache-inducing than tracking down lost materials or components or maintaining a detailed Bill of Materials (BOMs) for each medical device. A cloud-based ERP system automates both serial number tracking and BOMs, keeping you abreast of every step of the production process: what materials and components you need for each device; where they are at any given time; how to assemble them consistently and correctly; and where they are going once they leave your assembly line. Through automated processes such as tracking and BOM management, you can better comply with the FDA’s Unique Device Identification (UDI) requirements.

Traceability Challenge #2:  Process
Well-documented processes are the backbone of a successful business. And documentation is not just about compliance, it’s also about efficiency and effectiveness. ERP systems document each step of the manufacturing process, including production, assembly, testing, and packaging, ensuring that every stage is properly recorded and can be traced back if needed to identify any deviations or defects. And when it is about compliance, your ERP system should include proper validation and test scripts specifically designed to help medical device manufacturers comply with regulatory requirements such as FDA’s Quality System Regulation (QSR), ISO 13485, and other industry standards. These processes help ensure that traceability records meet regulatory standards and facilitate audits and inspections.

Traceability Challenge #3: Material Origin and Rapid ID
In the unfortunate case of a device recall or quality issue, ERP systems provide visibility into the sources of raw materials and components used in manufacturing. By recording supplier information, lot numbers, and other relevant data, manufacturers can quickly trace materials to their origins in case of quality issues or recalls. Your system will also enable rapid identification of affected lots or serial numbers to minimize the scope and impact of recalls, ensuring that affected products can be quickly removed from the market. And as a result, MDMs can maintain compliance with regulatory requirements, but more importantly, can quickly minimize the impact on patients.

Traceability Challenge #4: Integration with Quality Management Systems (QMS)
The backbone of any robust system is its compatibility with diverse environments. Whether in relationships, technology, or other fields, it is a key factor for harmony and effective functioning. Medical Device manufacturers require an ERP system with a quality module that supports activities from receiving, production, shipping and returns. Infor SyteLine ERP and CloudSuite Industrial for example have an embedded quality module providing quality records to auditors or customers covering your entire enterprise, not just the manufacturing process.

No matter the specific challenges you face, ERP systems provide a comprehensive platform for managing traceability in medical device manufacturing. From helping manufacturers ensure compliance, maintain product quality, to responding effectively to any quality issues or recalls, these capabilities will not only reduce your day-to-day headaches but also give you and your customers peace of mind.

Gold-Standard ERP Implementation Services

Copley Consulting Group has been an Infor Gold Channel Partner for nearly 30 years. We offer the expertise and project management resources to make your enterprise’s Infor CloudSuite™ or Infor SyteLine implementation seamless. We’ve helped more than 250 small- to mid-size manufacturers transform their operations worldwide.


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