Training Artsoft 2024

Which document contains an overview over the process structure of in4medicine AG QMS?

• Quality Management Manual

• Quality Politics

• Quality Goals

• SW-SOP-01-Software-Development

What processes do interact with the SW-Process directly?

• BA - Business Analysis

• TP - Testing Process

• MA - Management Review

• CM - Configuration Management

In Orcanos, the new qms software, how are changes for future software releases of SMASS documented?

• With Engineering Change Order Items (ECO)

• With Software Requirements

• With Risk Management Analysis

• With CAPA Work Items

On which work item in orcanos will the developer document the progress of the implementation?

• On the Engineering Change Order (ECO)

• On the software requirement

• On the user requirement

• In the Jira Ticket

The routing process of the software requirement work item goes from "in progress" to "ready for implementation" to "implemented" to ________ to "done"

If the developer finished implementing code for a software requirement, the developer will set the software requirement to the status...

• Ready For Testing

• Implemented

• Ready For Implementation

• Done

After a software requirement is implemented, what is the next step according to the routing process of the software requirement?

• Create test design

• Specify the requirement

• Set the requirement to status "done"

• Update the Engineering Change Order

A software requirement is in the status "ready for implementation". Why can't the developer change the status to "implemented"? Why is the software requirement locked?

• There are multiple developers defined for the same software requirement.

• The test design has to be created first.

• The software requirement is part of an Engineering Change Order wich hast not yet been released.

• The software requirement isn't fully specified yet.

If multiple developers are defined on the same software requirement and one of them has implemented their part, what does he/she do?

• Set the status of the software requirement to "implemented"

• Remove himself/herself from the assigned developers

• Route the engineering change order to the next status

• Write a mail to Aurel

What is a quality goal of in4medicine AG regarding the employees of Artsoft?

• All employees should have a maximum of 5 coffees a day

• All employees must have been trained at least 4h on the i4m risk management

• All employees must have been trained at least 4h on the i4m qms

• All employees must have been trained at least 8h on the i4m qms