ERP & FDA Validation: Full Lot & Serial Tracking

Share this blog
   

In this blog series, ERP Software & FDA Validation, 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.

From food and beverage to medical device, manufacturers in FDA-regulated industries have a responsibility to maintain end-to-end lot and serial number tracking and management of inventory.

FDA TraceabilityFaster Recalls

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.

As an example, HemoSonics, a manufacturer of diagnostic platforms for critical bleeding, recently migrated away from a homegrown solution that combined spreadsheets and manual processes to an automated ERP solution. Having gained approval for their product internationally, and pending approval in the US, the company was moving into full production and looked to Copley Consulting for an FDA Validated ERP solution that could keep up with company growth and compliance mandates, while reducing regulatory risk.

“With our existing processes, we lacked a consolidated system that could automate our manufacturing process. With Copley, we now have the system and processes in place to address FDA regulatory mandates and CE requirements, as well as satisfying financial compliance requirements. The new system includes mission-critical features such as serial lot traceability to track all components of our products through the manufacturing life cycle, and to meet FDA software validation requirements, thus ensuring quality control.”

 Steve Erwine, CFO at HemoSonics

 

Inventory Management

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.

 

 

ERP & FDA Compliance

 


Filed Under: Blog, FDA Validated