We are available for answring any question. Here we clarify the most common doubts that clients have. Feel free to contact us if you cannot find your answer.
FAQ
How can I know if my products are included in the regulations?
There are many products reached by the FSMA 204. You can find the list in our articles or go and visit the regulation article where the FDA enumerates all industries.
How can I know the steps in the value chain included in the regulations?
The FDA calls Critical Tracking Events to the steps in the Value Chain where they consider traceability mandatory. Those are Harvesting, Initial Packing, First Land Receiver (case of extracting fishing), Cooling, Shipping, Receiving, Transformation. To find out more about each, go to our blog where we explain what each of the means.
Are there exemptions for the rule?
Yes, in certain cases companies don't need to maintain this required additional traceability. We recommend visiting the official FDA website where you can find out about the exemption cases.
What is the information I must trace?
The information you must make available for the FDA are called Key Data Elements. It is different for each stage of the value chain. However, when you hire our services, our system will specify exactly what data you must collect from your processes. In this article we talk about the KDEs and CTEs explaining more about the information you must share and when you must share it.
What are the Traceability Lot Codes (TLCs)?
The Traceability Lot Codes (or TLCs) are the batch numbers to which the KDEs relate and/or belong. This is what connects the information of the entire value chain to a product.
In this article we talk about TLCs and why are they important.
Who will see the information about my products?
As platform managers, clients can give access to their employees to upload or read information. They can also choose which information is confidential and which information to share with their own clients. Darwin Evolution will store all the data but will only share what users decide.
Can Darwin Evolution be integrated with my ERP?
Yes! You can contact us and our Integrations Team will reach you out to help you or work with your ERP team to integrate both systems.
Can users upload files with products or processes information?
Yes! Darwin Evolution supports uploading CSV files or images with the process or batch information.
