In this special blog series, ERP Software & FDA Compliance, we’ll discuss the advantages of using an ERP system in an FDA-regulated industry. From organizing mission-critical documents to vendor management, you’ll learn how ERP helps keep product timelines in place and manufacturers in compliance.
Medical device manufacturers in FDA-regulated industries have a critical responsibility to maintain end-to-end lot and serial number tracking and management. Today’s ERP systems support this requirement through automated traceability technology, allowing manufacturers to track materials and products through receiving, production, inspection, shipping and more. Such comprehensive transparency allows organizations to increase the integrity of their data, enhance customer safety and protect their brand – while meeting regulatory requirements.
Here are three key benefits manufacturers can expect from ERP-enabled lot and serial tracking.
No manufacturer ever wants to face a recall, but if one is called for, regulators and consumers expect an efficient and effective execution.
Having full lot and serial traceability within your ERP system allows you to track problems throughout the entire supply chain, from origin to usage and back again, to determine the root cause. If the recalled product is one that’s been in circulation for some time, being able to pinpoint the source of the issue, be it raw materials from a given supplier or a defect in a particular batch, could mean the difference between recalling hundreds of products versus thousands.
Corrective Action/Preventative Action (CAPA) Support
Lot and serial traceability doesn’t just come in handy when things go wrong, like in the case of a recall. It also serves as a critical preventive measure, supporting the quality of your manufacturing process.
An ERP system equipped with lot and serial traceability facilitates review of materials at each phase of production. From inspecting materials to verifying suppliers, your ERP system can help administer a series of checkpoints to ensure a product continues to meet specification as it moves along the supply chain. If a point of weakness is determined through customer complaint or regulatory warning, changes to your quality system can be integrated into your ERP software. This will support your organization’s ability to carry out Corrective Action/Preventive Action (CAPA) processes and reduce the likelihood of future recalls.
In addition to helping manufacturers meet mandatory FDA guidelines, ERP-enabled lot and serial tracking can be a valuable tool for improving your bottom line.
It is not uncommon for manufacturers to maintain extra “safety stock” to avoid the risk of an unexpected shortage, which could cause delayed shipments or lost business. However, if your stock levels significantly exceed your actual needs, your organization could be wasting money purchasing and/or maintaining this inventory.
By tracking products at the lot and serial levels as they travel along the supply chain, you’ll gain enhanced visibility into real-time inventory numbers. Your ERP system can utilize these insights to help right-size your inventory to reduce waste and meet the needs of your business more cost-effectively.