FAQs
Where can I learn more about the SoftComply Information Security Risk Manager?
We have an extensive set of Knowledge Base articles about customisation and additional automation for the Risk Manager apps.
You are welcome to BOOK A DEMO call to learn more about the Information Security Risk Manager.
Why are some SOPs and Templates empty?
The Trial version of the SoftComply eQMS contains the full structure of a QMS, but very limited content is available in the Trial mode. You can access the entire content of the eQMS by purchasing the full license.
What happens when my evaluation period ends?
When your evaluation period ends and you did not purchase the license, the SoftComply eQMS’ functionality will stop working. Any Trial space deployed during the evaluation will still be available but it will not be possible to create any additional Trial QMS spaces and the macros will not be working.
What happens if I decide not to renew the license?
Any QMS space that you have already deployed will not be affected, but it will not be possible to create any additional QMS spaces and the macros will stop working.
If you choose to purchase the license, all features will become available again.
What standards is the SoftComply eQMS based on and where can I find them?
SoftComply eQMS is based on the latest version of: ISO 13485:2016, IEC 62304:2006 (as amended in 2008 and 2015), ISO 14971:2012 and 21 CFR 820.
I need help to customize my eQMS!
We are happy to support you. Contact us at info@softcomply.com or BOOK A CALL with our Regulatory Team.
We also have an extensive network of consultants who can provide dedicated and professional support.
Why can’t I create a new Risk Project?
There could be several reasons for this. Please have a look at your SoftComply Risk Manager configuration and answer the following questions here.
Why did my Risk Severity values change?
This is a feature of the SoftComply Risk Manager app that is related to the requirement of ISO 14971 for medical device risk management. To learn more about it and how to disable this option, please continue reading here.
Why do I see empty Risk Rows in the Risk Table?
For more information about why you may be seeing empty risk rows in the risk management table and how to avoid it, please continue reading here.
Which permissions do I need for the SoftComply Risk Manager?
Please read the Security and Permissions related questions and answers at the Risk Manager Security post.
