DKMAnet: User administration - questions and answers
How are users organised in DKMAnet?
From November 2011, companies will be able to manage their DKMAnet users in an other way than today. In the original version, each company had a Company Administrator (CA) who could create company users.
If the Company Administrator was to have access to new services on DKMAnet, he would have to contact the Danish Medicines Agency.
In the new user management setup, the company appoints a Security Administrator (SA), who will have access to all DKMAnet services. The company's SA can create users in the company with access to one or more services and can also set up himself as a user of services of his choice.
Finally, a user activity log has been added to DKMAnet, so that the SA can monitor user activity.
Why has the Danish Medicines Agency changed user management?
Today, DKMAnet encompasses more services and hence potentially more confidential information from each company, and we have therefore found it necessary to change the user management setup.
The new solution offers better possibilities of differentiating access to the various services, and the new activity log gives the companies overview and insight into user activity.
What will happen to the existing company administrators and users when we switch to the new user management solution?
Existing company administrators and company users will experience no differences when switching to the new user management solution. They will have the same rights as they have today.
The difference is that the company's Security Administrator will be able to change the rights of the company administrators as well as setup additional company administrators.
What user types are there on DKMAnet?
There are three user roles for companies that implement the new user management solution (possible from October 2011):
- Security Administrator (SA) – can create company administrators with access to one or more services. Can access the activity log. Can allocate the roles of CA and CU to himself and thereby gain access to using DKMAnet services. Note that there can only be one SA per company.
- Company Administrator (CA) – can create company users with access to one or more of the services delegated to the CA. Can allocate the CU role to himself and thereby gain access to using DKMAnet services.
- Company User (CU) – can use the services to which he or she has been given access.
Companies that have not yet switched to the new user management setup only have the latter to roles (CA and CU). These companies cannot use the new services until they switch to the new user management solution.
How does the company appoint a Security Administrator?
Once your company has decided who is to be the SA, you must order and install a digital employee signature on the SA's computer (unless that person already has one installed). Your company must then send a duly completed and signed "Form for appointment of Security Administrator" to the Danish Medicines Agency.
It will take us two weeks at most to process the application. Once we have set up the SA, he or she will receive an email from the Danish Medicines Agency.
Who should the company appoint as Security Administrator?
It is the company's own decision who to appoints as Security Administrator. But please bear in mind that the Security Administrator will have overall responsibility for selecting and setting up company administrators who thus have access to creating users with right of access to potentially confidential information about the company.
One option could be to appoint a person who currently acts as QP or someone who has similar, legal responsibilities.
If your company decides to appoint a person from the IT department (because the Security Administrator is to arrange for digital signatures for CAs and CUs), please keep in mind that he or she could gain insight into a number of business areas (Prices & Packages, Package leaflets, Company authorisations and Clinical trials).
What can the Security Administrator see and do on DKMAnet?
Generally, the Security Administrator (SA) can only use the services "User administration" and the "Activity log" on DKMAnet. As such, the SA role has no rights to access and use other services.
If the SA wants to use other services, the SA must setup himself/herself first as Company Administrator (CA) and then Company User (CU), because only the CA role can setup CUs with access to use services.
In the activity log, the SA can search on dates and names and thus gain an overview of who in the company have logged into DKMAnet, when they logged in, and which services they used.
What advantages are gained from appointing a Security Administrator?
There are many advantages of implementing the new user management solution:
- Automatic access to new services
- Access to exploiting the fine-meshed division of rights offered by the new solution
- Access to an activity log of the company's use of DKMAnet.
What should the Security Administrator do first?
We recommend SAs to read through the DKMAnet user administration guidelines that they received when notified of their establishment as SA from DKMAnet support.
When SAs log into DKMAnet, they have access to one service only: User administration.
Here, SAs can gain an overview of any existing users (company administrators (CAs) and company users (CUs) in the company.
Can we decide not to implement the new user management solution and proceed as today?
Yes, but you will neither be able to start using the new services nor be able to gain access to the DKMAnet activity log.
Can we implement the user management solution later?
Yes, you can implement the new user management solution at any time that suits you.
The "Form for appointment of Security Administrator" can be downloaded from the Danish Medicines Agency's website, and it is entirely up to the company to decide if and when it wants to implement the new user management solution.