On this page
10. Next steps towards finalising your file
The risks concerning your files
Now it is time for you to have a closer look at the risks concerning your file. There are two ways to do that:
- Click on the Risk Profile tab to get a visual overview of the current status of the file, or
- Go to the Requirements tab and evaluate what is still missing.
Next steps
The next steps could be:
- Issue your supplier another task (on the TIME LINE tab) to upload missing documents,
- Create an inspection plan, start additional testing to obtain missing evidence,
- Ask our expert team to perform a Label / Manual check
Monitoring your progress
On the Technical files page where you see a list of all your Technical Files, a status block indicates how many documents are still missing from the Technical file. The color of the block indicates the compliance risk, with red indicating a high risk, orange a medium risk and green a low risk.
By placing the mouse pointer on the block, an overview appears of all missing documents, grouped by risk level.
The risk level is classified as high by default for all documents.
You can adjust this to medium or low for specific documents at your own discretion, possibly only for specific projects, file groups, product risk levels and product categories.
|
Status |
Meaning |
|
|
13 documents are missing, at least 1 of which is high risk |
|
|
5 missing documents, medium or low risk, at least 1 with a medium risk |
|
|
3 documents are missing, all with a low risk |
|
|
All documents have been collected |
|
|
No regions or product category have been chosen yet |
|
|
20 documents are missing, but the file deadline is more than 6 weeks in the future (the 6 weeks mentioned will be a customizable account setting) |
|
|
No regions or product category have been chosen yet, but the file deadline is more than 6 weeks in the future |
|
|
The file has not yet been activated |
I have gathered enough evidence
When you decide that you have enough compliance evidence in order to release the product into the market, you should set the file to FINAL status. Go to the Product tab, Click on the active state in the toolbar (example image below) then set the status of the file to Close for final review.
Finally, a situation may arise in which changes are made in the legislation applicable to the file after the file has been created and activated.
This usually occurs when the market release date of the file is further in the future. The further the date, the greater the chance that new legislation will be published in the interim that was not known at the time the file was created.
For such files, a red banner has been shown in the file for some time to make aware of this, with a link with which you can update the list of requirements free of charge.
It is now also possible to create a tab on the technical files page that shows all files that need such an update.
The validity of your Technical File for reorders
The column reorder expiry shows the date from which the file is no longer suitable as proof of compliance for a reorder of the product, because from this date one of the documents is no longer valid or new legislation comes into effect that is not included in the current list of requirements of the file.
Clicking on the date shows an overview of expired documents and changes in the requirements list per the reorder expiry date or per today if that date is in the past.