User Roles in meddevo: Overview and Application
In meddevo you can find two types of roles: The Company Roles and the User Roles.
Company Roles are used on Workflows and define who can start an approval, who can review data and documents and who can perform the final approval. Learn more about them here.
User Roles define who can use which features in meddevo. In the past, User Roles were organized by certain features (for example: can or can not edit a certain data type) but will in the future be organized by certain role requirements (for example: the "Post-Market Surveillance" role will be able to do everything necessary in the context of Post-Market Surveillance procedures).
It is important to understand that a user needs only one role. It is not necessary to add several roles. In case you have someone who has responsibilities in more than one area (for example: Clinical Affairs and Post Market) the "Full eTD User" Role is the appropriate one for them.
| Role Name | Can | Can not | When to use this role |
| People that can add, change and delete things | |||
| Administrator | Can access all functionalities of meddevo. The Administration can access the Admin area, change roles, change workspace settings, change any data and document and participate in any workflow activities. | Assign Administrator to your top level meddevo user ("Key User") that has main responsibility for the workspace. This role has the broadest authorisations and should be provided only to users that are very familiar with meddevo. | |
| Clinical Affairs | At present, users in this role are granted the same permissions as Full eTD Users. In the future, their permissions will be adjusted to fit the specific needs and duties of the role. | Access the administration area. | Assign this role to all users that work ONLY in Clinical Affairs and not in other areas of Regulatory Affairs. |
| DMS & Approval | At present, users in this role are granted the same permissions as Full eTD Users. In the future, their permissions will be adjusted to fit the specific needs and duties of the role. | Access the administration area. | Assign this role to all users that work ONLY in the document management system and approve documents and data, but dont work in other areas of Regulatory Affairs. |
| eTD Full User | Read, add, change, delete and export any data and documents. | Access the administration area. | Assign this role to all users that work in Regulatory Affairs (and might also cover some of the other fields). |
| Post-Market Surveillance | At present, users in this role are granted the same permissions as Full eTD Users. In the future, their permissions will be adjusted to fit the specific needs and duties of the role. | Access the administration area. | Assign this role to all users that works ONLY in Post Market Surveillance and not in other areas of Regulatory Affairs. |
| QM | At present, users in this role are granted the same permissions as Full eTD Users. In the future, their permissions will be adjusted to fit the specific needs and duties of the role. | Access the administration area. | Assign this role to all users that works ONLY in Quality Management and not in other areas of Regulatory Affairs. |
| Read only | Read any data and documents. Can add and read comments on any data and documents. | Cannot add, edit, delete, restore any data or documents. | Assign this role to any user that shall be able to read documents and data but has no permission to change product data and documents. |
| Research & Development | At present, users in this role are granted the same permissions as Full eTD Users. In the future, their permissions will be adjusted to fit the specific needs and duties of the role. | Access the administration area. | Assign this role to all users that works ONLY in Research & Development and not in other areas of Regulatory Affairs. |
| Submissions/Registrations | At present, users in this role are granted the same permissions as Full eTD Users. In the future, their permissions will be adjusted to fit the specific needs and duties of the role. | Access the administration area. | Assign this role to all users that works ONLY in Submission/Registration and not in other areas of Regulatory Affairs. |
| Workflow User | The user can read all data and documents, start workflows, perform review and approval workflow steps. | Cannot edit data or documents. | Assign Workflow User to anyone who makes final decisions on data and documents but does not necessarily work on the data themselves. This is a role for example given to the Head of Regulatory Affairs. For some companies this role might be given only to top management. |
OLD ROLES; PLEASE MOVE AWAY FROM USING THESE | |||
| Content Manager | will be faded out, please replace by any of those above | ||
| Content Creator | will be faded out, please replace by any of those above | ||
| Document Manager | will be faded out, please replace by any of those above | ||
| Content Reviewer | will be faded out, please replace by any of those above | ||
| Document Reviewer | will be faded out, please replace by any of those above | ||
| Content Approver | will be faded out, please replace by any of those above | ||
| Document Approver | will be faded out, please replace by any of those above | ||
| Content Viewer | will be faded out, please replace by any of those above | ||
| Document Viewer | will be faded out, please replace by any of those above | ||
At the moment, we advice against creating own user roles. The current roles system is very complex and easily missunderstood.