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.
When a shipment arrives at your facility, how can you be certain that the materials that have been delivered meet your expectations? Rather than testing the parts on the spot or waiting to find out what your customer thinks of them, your supplier provides a certificate of analysis, or COA. The COA contains test results that affirm that the product or raw materials meet the quality requirements you’ve established. In some regulated industries, COAs are required by the FDA. As regulations become increasingly stringent, as seen in the recently implemented Food Safety Modernization Act (FSMA), manufacturers will need to work closely with suppliers to maintain detailed records confirming batch consistency and ingredient/part integrity.
While you may be “checking the box” by filing hard-copy COAs from your shipments, a paper-based system does your business no favors. Integrating electronic COA management into your ERP system can benefit your company’s operations – and bottom line. Here’s how.
Productivity & Efficiency
When managing COAs in your ERP system, you have the ability to configure data using custom settings, enabling the information you need to be available even before a shipment arrives. Why is this important? Having COA information available to all departments can assist in minimizing disruptions and keeping your production line running as a well-oiled – and cost-effective – machine. For example, with advance COA information in hand, you can optimize processes by being on the lookout for inconsistent materials, increase safety stock to make up for availability issues or increase work in progress (WIP) inventory to close gaps in production line efficiency.
Root Cause Analysis
Even if a given shipment meets specification on paper, that doesn’t totally eliminate the risk of product variations, returned goods or even recall. Compiling and analyzing electronic COA data such as product description, lot number, batch number, manufacture date and expiration date can be critical to determining the root cause of such problems (and may be requested in the case of an audit). Knowing the source of these issues, you can configure your ERP system to alert you when these conditions occur again to avert potential problems and ensure optimal quality and yield.
Quality & Compliance
As discussed in our last blog, managing the supplier approval process is a critical responsibility for manufacturers in FDA-regulated industries. Tracking COA data goes one step further by allowing you to keep tabs on supplier quality on a regular basis. After a supplier has been certified, you can monitor ongoing performance by tracking and studying COA data. This information can be pertinent to contract negotiations, specification changes and yield adjustments. It may also throw up otherwise overlooked red flags that a certified supplier is exhibiting quality variability. By managing COA data in your ERP, you are better able to hold suppliers accountable post-approval, discuss performance in tangible terms and ensure their services remain certifiable and compliant.