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Products vs Product Families, and Compliance Documents vs Product Files

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Understanding the precise meaning of terms like 'Products' vs 'Product Families', and 'Compliance Documents' vs 'Product Files' is crucial for building your product compliance document management system, and for effectively using the PCM platform. This detailed explanation will help you accurately interpret and apply documentation requirements, preventing compliance gaps that ...

Understanding the precise meaning of terms like 'Products' vs 'Product Families', and 'Compliance Documents' vs 'Product Files' is crucial for building your product compliance document management system, and for effectively using the PCM platform. This detailed explanation will help you accurately interpret and apply documentation requirements, preventing compliance gaps that could lead to regulatory risks. You will be able to confidently manage and verify your product compliance across their entire product range.

A 'Product File' in our PCM software platform is a collection of compliance documents for a product(family). 'Compliance Documents' are documents that provide proof of compliance with the applicable regulations for a product, its components, or its materials.

For example, a test report is a compliance document that generally provides proof of compliance of the tested sample with (typically) one regulation or a set of standards under a regulation. The test reports can be used for those products/models that are specifically listed in it. Usually, a test report does not provide assessments of all requirements of all applicable regulations. Therefore, in most cases a Product File will contain multiple test reports and assessment reports.

Let's clarify with a practical case: A supplier provides you a test report for a test for SVHC (Substances of Very High Concern) for the lid of a plastic container. The report mentions models XYZ and Z123 and the colours red and green.

This means that:

  1. The test report covers only the lid. If the container is made out of another plastic material, the test report cannot be used for the container itself. You will need to get the test report for the container as well.
  2. Only the colours red and green are covered by the test report. The yellow coloured lid is not covered, and you will need to get the test report for it as well.
  3. The test report cannot be used for models ABC24 and NYC22, if you sell those as well. You will need to get the test report for those as well.
  4. Other aspects for containers, such as compliance with Food Contact Materials regulations or the risk assessment for the General Product Safety Regulation (EU) 2023/988 are not covered by the test report in this example and you will have to provide other reports to prove compliance for those aspects.

A test report, or collection of test reports can only be used for a family of products if the products in that family are equivalent from a regulatory point of view. Or in other words, if they share the same design, same technology, same intended purpose and are therefore covered by the same regulations. if this is not the case, you would add a new Product File.

If you have questions or need clarifications, please do not hesitate to reach out to our customer support team.