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Certificates of analysis editing

January 30, 2023

6 min

Lionel Murat
Cofounder of CIKLab

Beautiful watches come in beautiful boxes, cosmetics have beautiful packaging, good products come with good quality documents.

The importance of quality documentation

Paper salesmen… 

In some industries, such as ingredients, quality documentation is more important than the product itself… Surprising, perhaps, but hardly exaggerated.

It is indeed the specification sheet that allows your customers to choose your products and the certificate of analysis that proves its authenticity, its origin, its quality.

All customers, regardless of their place in the value chain, check the data in their suppliers’ certificates of analysis. Sometimes this is even the only control carried out to release a product.

Documentation is a guarantee of reliability and trust. It is the technical documentation, rather than a commercial brochure, that will enable your customers to choose a product. A complete and well-done technical file is the first proof of the quality of your products.

On the other hand, if the documentation is not good, how can you expect the product to be good?

It is therefore essential to offer impeccable quality documentation, both in terms of content and form. In addition to being a technical document, it is the primary marketing and sales argument.

Essential information on spec sheets and CoAs

From a quality point of view, a product is just a set of analyses and results.

A certificate of analysis responds to a specification sheet or data sheet.

  • The data sheet indicates the theoretical parameters that a product must respect.
  • The certificate of analysis gives the precise results specific to a batch.

Ideally, the certificate of analysis will contain exactly the same information as the specification sheet, with the addition of details about the batch in question and the test results. It is therefore necessary to be vigilant so that the certificates of analysis and the specification sheets are updated at the same time.

The regulations in force according to the industries are more or less precise concerning the information to be found on the specification sheets and the certificates of analysis, but globally, the same information is found.

 

Specification sheet

Certificate of analysis

  • Supplier information
  • Product identification
  • Specification
  • Validation
  • Life span
  • Composition
  • Conditioning and storage conditions
  • Parameters to be analysed
    • Analyte
    • Specification (span + tolerance)
    • Unit
  • Version of the specification sheet
  • Date of edition
  • Identity validator
  • Supplier information
  • Specification
  • Validation
  • Product identification
  • Batch Identification
  • Analysis results
  • Etc.

Focus : Certificate of analysis vs. Certificate of conformity

There is sometimes some confusion between certificates of analysis and certificates of conformity.

Obviously, each industry has its own standards and practices, but in theory :

  • A certificate of analysis contains only the results of analyses performed on a particular batch.
  • A certificate of conformity represents the company’s commitment on all the parameters and the overall conformity of the product, without giving the results of analyses.

For ingredients, most certificates include analysis results and compliance information.

Generally, physico-chemical parameters, active ingredients and microbiological activity are tested systematically. On the other hand, contaminants (heavy metals, pesticides, PAH) are tested periodically.

CoA edition

As we have already discussed, most manufacturers do not have software dedicated to quality control and the edition of certificates of analysis. All their quality control is managed through Excel files and Word documents.

The edition of the certificates of analysis is therefore a very tedious work for the quality managers who have to compile the data, enter the information, check, save and validate these documents.

Mano mano

The easiest way to proceed is to create a model certificate by product or by product family. For each batch, you just have to modify the necessary information (batch number, expiration date, validation date, etc.) and update the analysis results.

Once the certificate of analysis is ready, you have to print it in .pdf format, save it in the right folder while respecting the nomenclature to be able to find it, then validate it by adding a signature.

As everything is manual, it is possible to edit personalized certificates according to the customers’ needs.

On the other hand, filling in the certificates of analysis requires a lot of vigilance in order not to make any input errors. Also, it is a very time consuming activity because it takes an average of 10 to 15 minutes per certificate.

For a company that releases 200 batches per year, this represents 50 hours or 1500€.

Roi de la formule Excel

Without too much knowledge of Excel and Word, with simple search formulas, it is possible to automate the process a little. You can edit a certificate of analysis from information entered in an Excel database. This will save time in filling in the document and above all avoid typing or copy/paste errors.

You start by grouping your products that share the same analyses.

In a first tab, you create your database of analysis results

Product

Batch

ANALYSIS 1

RESUL. 1

ANALYSIS 2

RESUL. 2

Etc.

Product A

1234

>10%

11%

Conform

Conform

 

Product B

6789

>5%

6%

Conform

Conform

 

Then, define print masks and search for information according to the batch number for example.

Product A

 

 

 

Batch number

1234

  
  

Spec

Result

 

Analysis 1

>10%

11%

 

Analysis 2

Conform

Conform

    

Product B

 

 

 

Batch number

6789

  
  

Spec

Result

 

Analysis 1

>5%

6%

 

Analysis 2

Conform

Conform

    

This will save you a lot of time, provided you have a limited number of products or families. Unfortunately, the files become heavy very quickly and the queries take too much time. Above all, it is much more complicated to adapt certificate masks to customer or product specificities.

Also, updating quality documents can be a real headache. Moreover, each change has to be made twice, on the data sheet and on the certificate of analysis.

In an automated system with formulas, every change can break the formulas.

If you are on a manual system, you may have to modify each file individually:

  • Imagine having to change a logo or an address in 250 product sheets?
  • Imagine having to change the name of a regulation in 1,000 model certificates of analysis?

A simple and efficient solution to edit your certificates of analysis?

With CIKLab, the quality control management software, the edition of certificates of analysis is automated.

At the same time as you manage your control plans and follow your batches, you prepare :

  • Your specification sheets
  • Your certificates

Specification sheets creation

In CIKLab, you start by creating your products.

From your catalog :

  1. You add the analyses you want to perform on your products
  2. You adjust the specifications.
  3. You decide which parameters should be visible to your customers
  4. In 1 click, you edit your updated specification sheet in .pdf

If needed, you can adapt the design according to your visual identity.

If you manage different specifications for your suppliers or if a customer has particular specifications, you can simply manage it in CIKLab.

Certificates of analysis edition

When you create a new batch, CIKLab helps you choose the analyses to be performed and order them from your laboratories.

Upon receipt of the reports, the analysis results are entered into CIKLab and a validation process allows you to close and release the batches.

Then, in one click, you automatically edit your analysis certificates.

They are directly signed and printed in PDF, named according to a precise nomenclature and directly linked to your products and batches. All the documentation is available in your online library. You no longer waste time saving your documents in a complex tree of folders. You can even authorize your sales representatives to access technical data sheets and certificates of analysis, but not other quality documents.

Customers-specific sheets

To edit a technical sheet or a customer specific certificate of analysis, it’s even faster.

From your standard product, you create the specifications of your customer and edit his data sheet. To edit a certificate of analysis, you can import the results of your standard product and edit the certificate that corresponds to the customer’s specifications.

The traceability management allows you to go back to the source product without any risk of error.

With CIKLab, you can easily edit your certificates of analysis, you limit the risk of error and you save precious time in the management of quality control.

Do not hesitate to contact us for a demonstration or a trial!

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