Actors and Roles

Top Level Management coordinates the different activities.

It gets reports from QA Manager, Lab and test session Managers & Auditors.

The KEREVAL Health Lab Manager managesthe activities ofKEREVAL e-Health laboratoryand maintains thetechnical expertiseof the laboratory.
He is responsible for theimplementation ofdefined processesand applicable totheIHE.

A substitute is identified for this role.

The lab manager and his substitute must be qualified.

A committee which role is to ensure the quality of the testing process, discusses the needs and decides on what needs to be done in term of quality

Manages the QA.

Gets input from the QA Committee and reports to Top Level Management

The role of independant auditors is to verify that the QMS processes and testing references  are correctly used and/or respected.
Auditors report to the Top Level Management.

They must be qualified.

Manages the testing session.
Organizes the testing activities, reports to the Top Level Management.
Follow the rules from the QA Committee to ensure the overall quality of the process.

They must be qualified.

Verifies and validates the tests performed by the Systems in accordance whith the test cases described in the Gazelle Management tool.
Monitors act under the responsability and guidance of the Test Manager.

Monitors can be either external or internal resources, depending on type of test sessions.

In any case, they must be qualified.

SUT Operators execute on their SUT test steps required by the test.

SUT operators are by definition external resources, belonging to Health companies.

They must be qualified.

Manages the development team.
Organizes the release activities, reports to the Top Level Management.
Follow the rules from the QA Committee to ensure the overall quality of process

They should follow the processes set up for the development of the test tools and should develop the test tools taking into account the state of art in this field. They are also Testers.

Technically skilled professional who is involved in the testing of KEREVAL Health Lab test tools.

According to the level of testing, testers can be either developers, or dedicated testers within KEREVAL or SUT operators for Beta testing (involve testing by vendors or any SUT operators who use the system at their own locations and provide feedback to Test Tool Developers).