A Certificate of Analysis (COA) is a document that manufacturers produce that verifies the product they manufactured conforms to their customer’s requirements. It is important for the customers to know that the product they are receiving adheres to their specific parameters and targets, and to ensure that it meets their needs. COAs help your company prevent costly returns, replacements, or customer complaints. In this article, we will discuss exactly why COAs are so important and the best way to manage them within your company.
The Food and Drug Administration (FDA) lists specific requirements for each COA document your company produce. These include;
Without each of these sections and data, your COA will not count as a legitimate inspection of your product, and you may run into legal or business ramifications.
As previously mentioned, COAs are documents meant to prove the products you are manufacturing are up to your customers’ expectations. With countless items being produced by manufacturers, it is often difficult for a company to seamlessly track materials from the very beginning to the end of the final product process. This means that companies rely more and more on their suppliers to provide quality materials for finished products.
A COA goes beyond just acting as a product inspection as well. With materials rapidly moving to and from different locations, it is necessary to have the shipped material clearly and correctly identified and clarified. In addition to material and container labels, the COA serves as an identification document for the status of each product. These documents provide more detailed information than a label generally provides. The COA conveys information from a material supplier to a material user about the identity, quality, and purity of that specific material. It is very important for a material supplier to show its customer a trustworthy COA so that the customer can understand exactly what type of product they receive. The receiver can also compare the information provided on the vendor’s COA against its specifications to see whether the material meets the required criteria.
Many manufacturers know there are advantages to creating COAs but consider them too costly and time-consuming. However, without producing a trustworthy and accurate COA, your company could face both business and legal consequences. These include, but are not limited to;
The price of not having COAs is quite high, much higher than the cost to produce COAs in the first place. Without these documents, your company could very likely lose money, customers, and even credibility within your industry. While the process to begin creating and distributing COAs may seem daunting, a document management system (DMS) can help.
As important as COAs are for companies who manufacture products, it can be challenging to figure out how best to collaborate on and organize them. If you opt to manage them manually, with a paper system, you are increasing the likelihood of human error and losing vital business efficiency. However, with a document management system like ENSUR, you are provided a central location for all your COAs. Using a DMS, your company can realize the following benefits:
Employees will no longer need to save files to their computer hard drive, shared drive, or a USB stick, they simply log into their document management system and access any document they need in seconds. The time your employees would be spending sifting through paperwork or searching for documents can be used for more essential and important business practices, increasing overall efficiency, and ensuring that your company stays in compliance with all FDA regulations.
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Contact us for a demo or for more information about how our ENSUR Document Management Software can streamline your certificate of analysis process.