The development of a medical device is a very complex undertaking: Requirements must be precisely and traceably recorded, implementation in hardware and software must take place, and extensive testing must be performed to ensure the correct and hazard-free functionality of the device. Last but not least, all these processes must also be extensively documented and approval documentation generated.
In order to be able to cover all aspects of these three major topics of requirements management, test management and documentation generation, tool support is absolutely necessary given today's complexity. One of these tool landscapes comes from IBM. This formerly consisted only of DOORS (Dynamic Object Oriented Requirements System - requirements management), was then expanded to include RQM (Rational Quality Manager - test management) and has since been renewed to DOORS Next and ETM (Engineering Test Management). Finally, everything was merged into a common framework called IBM ELM (Engineering Lifecycle Management).
Using such tools can help modernize and make workflows more consistent, as well as comply with regulations and enforce certain processes. In addition, such tools provide support for creating requirements and tests, as well as modern data management and querying. Nevertheless, it is not always easy to achieve embedding in existing processes, as these tools are often very complex and initially confusing without support in their introduction and use.
The IBM tool landscape for building and managing a product lifecycle was started in the 1990s with DOORS and then gradually expanded to include RQM and later molded into a new platform with ELM. In overview, there are currently the following components of the platform:
The big advantage of ELM is that it is a complete platform that integrates all tools. In contrast, if you use the classic variant for capturing requirements DOORS, the cooperation with RQM and RPE is much more complicated, the interface is more rudimentary and some functions cannot be used.
The general benefit of using the above tools in a systematically correct way that fits the workflow can be seen in the following diagram:
The tools support in almost all areas of the diagram shown above and help to manage data and comply with processes in a structured way. This includes change management, Risk Management, requirements, and all types of test specifications. It is also possible to assign these elements to / divide them into components of the system.
All of the tools mentioned in the previous section are extremely powerful and flexible, offering the user many ways to design the workflow they want or to customize the tools to fit the workflow they are using. Even in the smallest detail, the tools can usually be adjusted very precisely. In addition to many setting options in the graphical user interface, the tools usually also offer open web interfaces for automated access to the managed data. They also allow the user to program the entire configuration right away, as is the case with RPE, where you first have to write a template to specify how the generated documents should look and where the used data should come from.
Dr. Torben Scheffel, qtec expert
We have the expertise to help you both with the introduction, use, configuration or enhancement of these tools, and to develop or refine workflows with you that fit into your ways of working. Our experts have experience with the classic variants of these IBM lifecycle management tools such as DOORS, the more modern variants, as well as with programming template files for the automated generation of documentation using RPE
Another aspect of our service offering is to import regulatory standards and guidelines into DOORS and attribute their elements. This allows elements of the product lifecycle such as requirements and test specifications to be linked to the relevant clauses of the standard.