Scilife has a new module! Finally, risk management is made a whole lot simpler, as well as accessible by everyone. In our webinar on Scilife's new Risk Assessment module, CEO Filip Heitbrink discusses:
No, the tool is provided empty. During onboarding we help with configuring risk assessment types, but right now the user should define the risks manually. However, we might create a list of predefined and editable items in future versions.
It's only possible to add text when describing a risk in the risk assessment module at the moment. Once you link it to a CAPA, you have the opportunity to upload attachments in the CAPAs module.
You can add this information in the remarks field.
In short, no, approvers cant make direct modifications, but they can leave a comment. You can add more than one person that's going to work on the risk assessment, and then there's an approval step. An approver can only reject the risk assessment and send it back to the responsible person with a remark, as they must specify a reason for the rejection.
You can add more users in as 'responsible persons' for the risk assessment. You can see and track who makes changes and who saved what. You can also download and view all the risk assessment versions. You can also add multiple approvers that all need to sign off, or just one, it’s up to you.
Usually, you need to be a manager to create risk assessment types. However, this is configurable by you. Under the 'manage' tab you can define who can create risk assessment types and choose between admin, regular user, or manager.
No, you cannot close your CAPA if the risk assessment is still open. First you do your risk assessment, create mitigating actions for your risk, then automatically create a new CAPA, and that CAPA goes into implementing status where everyone closes their actions and uploads proof . You can close your risk assessment before the CAPA is closed.
Yes, there is a dependency. You cannot close your CAPA if the risk assessment that's linked to it is not closed.
Yes, you can still define a mitigation plan without the CAPA module. However, you need the CAPA module to assign risk assessment tasks to the right people so they can perform and sign off on the risk assessment and upload proof. That's why we advise everyone to link their risk assessments to CAPAs.
Yes, there are two options for this. Clicking 'Download as PDF' creates a report of your whole risk assessment. You define your own PDF template and layout with custom variables through the Document Control module, which will include electronic signatures etc. If you only want to download the FMEA as an Excel then you can hit 'Download as Excel'.
Yes, in the same way as described above, by downloading a detailed PDF report.
Yes, both ways are possible. All modules are interlinked.
The mitigation plan is an open text field, you can put as many options there as you want. If you link it to a CAPA, and you don't want to put everything under one action, you're free to add additional actions within that CAPA and then split your mitigation of a risk into several actions. Right now, the mitigation that you define is linked one-on-one to the risk. You can add several different mitigating actions for a risk in the text field of the mitigation plan.
According to the order you created. You can add and remove rows as you wish
At the moment we're implementing the most widely used methodology first, as time goes on we'll add more features and tools in our next iterations.