How to Create a Certificate of Analysis

While the format of your Certificate of Analysis can vary depending on your needs, there area 5 key information elements needed to create a Certificate of Analysis

  1. Supplier Information
  2. Materials Identification
  3. Transportation Information
  4. Conformance Evidence
  5. Signature Data

The functionality found in our Data Management Module will help your team quickly define and populate these elements when creating a Certificate of Analysis. Detailed below is a brief explanation of each element.

Requirements for a Creating a Certificate of Analysis

CERTIFICATE OF ANALYSIS REQUIREMENTS

Supplier Information

Supplier Information

This information is generally found in top section of a Certificate of Analysis and it contains identification information about the material supplier. Most often, the content will have embedded graphics, such as the company logo, along with addresses and other pertinent contact information. This data may be different for products shipped from a common source if, for instance, the manufacturer supports multiple brands or acts as a contract manufacturer for others.

Materials Identification

Materials Identification

The content presented here identifies the material being certified by this Certificate of Analysis. This section contains such common terms as item ID, product codes and descriptions. This is also where you will find the lot number(s) or serial number(s) of the products identified. The conformance evidence presented in the COA should be directly attributed to the materials and lots/serials stated. Sometimes, the evidence relates to material that was produced and then packaged. Care should be taken to ensure that the trace records linking the final packaged products to the fill materials are maintained.

Transportation Information

Transportation Information

Typically, transportation-related content is also provided when creating a Certificate of Analysis in a make-to-order industry. This content may include the Ship To customer name and address, original purchase order, the bill of lading number or other details such as destination, trailer or rail car number. This content in the Certificate of Analysis is generally provided to meet shipping requirements and to aid the receiver in confirming the material is authorized and expected. With this information, the receiver can track the shipment in their records and confirm chain of custody. This area of content may be omitted in circumstances where the same lot of materials is shipped to multiple customers for products produced on a make-to-stock basis.

Conformance Evidence

Conformance Evidence

The primary value of creating a Certificate of Analysis is in the evidence data presented in the body of the document. The specific characteristics, test results or other evidence cited is often defined by industry standards, regulatory requirements or customer-specific request. The same evidence might not be cited on each document and both the content and layout of the data may vary depending on your customer’s specifications. Typically, an identifier of the test or standard is provided and a result indicating that monitoring processes occurred is presented. In some cases, the performance standards (specifications) expected will also be shown for reference. It is expected that source records can be provided to substantiate evidence cited on the COA.

Signature Data

Signature Data

This last section of the COA may include a specific signature and title or boilerplate language indicating that the evidence presented was reviewed by a person authorized to complete such a review. There may also be additional boilerplate content identifying any special circumstances or properties of either the material or the evidence-gathering process. While we list it last in our explanation, there is no requirement that this content be located in the footer area of the report.

CREATING CERTIFICATES OF ANALYSIS TO SUPPORT SHIPPING DEADLINES

When creating Certificates of Analysis to accompany shipments, Quality Control and Quality Assurance departments are very aware of the need to generate accurate documents in coordination with shipping time-frames. They know that, in many cases, their customers are not authorized to accept a delivery if the Certificate of Analysis does not accompany the shipment. Receiving inspectors will want to examine the Certificate of Analysis before accepting a delivery to confirm that products conform to specifications.

Managing the process of creating Certificates of Analysis quickly and accurately, so that shipping deadlines are not missed, is a major focus of attention. This is especially true when paper- and spreadsheet-based tools make the processing steps cumbersome and time-consuming. Any crisis or shift in resources can delay documents and threaten on time shipping goals.

The Data Management module from Quality Essentials Suite provides a lengthy list of functions and features developed specifically to address the needs for prompt creation of Certificates of Analysis and to eliminate bottlenecks. Not only are the documents easily generated from the entered data, but they can be electronically delivered to customers automatically as part of the printing process.

To learn more about how our solution can affordably help your team overcome their bottlenecks and backlogs, check out our Pricing page. Then be sure to contact us and ask for a product demonstration.

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