Why You Need Certificates of Analysis and How to Manage Them

What makes up a COA document?

The Food and Drug Administration (FDA) lists specific requirements for each COA document your company produce. These include;

• Supplier Information: This section contains data regarding the material supplier, including their name, address, and other contact information.
• Materials Identification: The content in this section identifies the material being verified by this COA. And it usually contains common terms such as lot numbers, product codes and descriptions.
• Transportation Data: This area generally includes the customer name and address, original purchase order, or other details such as the item’s destination. This content is provided to meet shipping requirements and to help the receiver in confirming the material is authorized and its delivery is anticipated.
• Evidence of Conformance: This section holds the most important information in the COA. It states the specific characteristics, test results or other evidence in terms of industry standards, regulatory requirements or customer-specific request. In some cases, the performance standards expected will also be noted for reference.
• Signature Data: This last section of the COA includes a signature indicating that the evidence presented was reviewed by a qualified and authorized product inspector.

 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.

What are COAs used for?

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.

Why does your company need to produce COAs?

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;

• Decreased confidence in what gets shipped out
• Increase in product recalls, wasting company time and money
• Audit process becomes more complicated
• Competitors can get the edge when they produce COAs and you do not
• Lost customers

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.

How Should You Manage COAs?

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:

• Control the COAs you create and send to your customers using the DMS audit trail, electronic signatures, and template version control
• Easily distribute COAs with overlays, form reports, address book/contact distribution, and publishing to external locations like file shares
• Configure your content types using default routing and LOT numbering
• Structured data that allows for field based searching, exporting, and reporting
• Use of concept of "Master COAs" to lock data that COA editors should not be editing

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.

Check out our other resources on this topic:

• 4 Main Components of Manufacturing Quality Management
• The ROI on a Specification Management System: Is It Worth It
• How to Reduce Human Error During the Manufacturing Process
• The Manufacturing BOM: Managing the Document that Pilots Your Supply Chain

Contact us for a demo or for more information about how our ENSUR Document Management Software can streamline your certificate of analysis process.