Validation is a process of analysis followed by an evaluation based on evidence whether an object (e.g. process, documentation, software or application) meets the user’s requirements, especially as regards security and quality, also with an emphasis on the operational suitability for the use in the intended operational environment.*
In short, validation provides the answer to the question: Has the right thing been developed?
Validation conform to standards
In cooperation with you we would draw up a validation plan, which meets the applicable standard and we agree the defined validation strategy with the people / authorities (e.g. an assessor or quality control) which are checking the validation.
We will support you in your validation activities during your development process. To us it does not matter whether your development process is based the waterfall model, the V model or an agile development approach (e.g. SCRUM). We are familiar with all of them. In cooperation with you, we will define the optimal validation strategy for you.
System validation / product validation
We will carry out the validation for in line with the standards and parameters required by you, regardless of whether this is for a system or a product (part of a system). The review of the system specifications, the interface documents, the architecture and the design documentation are as much part of this validation as the statistical analysis of the software (when checking measures ensuring quality control), the review of the verification tests / evaluation of the test results as well as drawing up and carrying our own validation tests. Based on our long experience with regard to system validation and product validation we can select and carry out the optimal validation activities for your system / product.
Validation of tools supporting the development processes (tool validation)
During the manufacture of products, tools supporting the development process, such as requirement management tools, development tools, test tools or EDP systems are being used. These tools must be assessed to see whether they are required for a validation. certitudo GmbH can support you in indentifying the tools requiring validation and plan and carry out the respective validation measurements. These measurements comprise for example drawing up validation test cases, test data capture, carrying out the test(s) as well as a final creation of the validation report. We use risk based approaches to capture the validation measures optimal for the respective tool.
One of the most important tasks when validating is the evaluation of the requirements traceability matrices. One differentiates between horizontal and vertical requirement traceability matrix.
The horizontal requirement traceability matrix shows the relationship between the requirements and the test cases as well as the test results. This matrix is used to determine the system or the product cover of the requirements per release. If a requirement is not linked to a test case or the linked test case has not been carried out, there is a requirements cover gap. This gap must be evaluated with regards to the functional effects on the system and the product respectively. If a test case has been carried out and the there is only a negative test case result, the functional effects on the system and the product respectively must be evaluated using the fault analysis.
The vertical requirement traceability matrix shows the relationship between the requirements and the design documents as well as the source code. This matrix is used to show how and where the requirements are implemented in the software. If a requirement is not linked to a design document or part of a source code, there is a requirements cover gap (the requirement has not been implemented in the software). This gap must be evaluated with regard to the functional effects on the system and the product respectively.
With more than 10 years’ experience in carrying out multiple validation projects, certitudo GmbH is very well placed to support you in the technical creation of the respective requirement traceability matrix as well as in the evaluation of the requirement traceability matrices.
Berliner Verkehrsgesellschaft (BVG), the transport authority in Berlin, has installed the most modern control and safety technology for the southern part of route U6 between Stadtmitte station and Alt-Mariendorf station, comprising an electronic interlocking at Mehringdamm station and remote position in Alt-Tempelhof and Alt-Mariendorf, as well as a further remote operating terminal.
This largest combined interlocking project ever carried out by BVG was fully commissioned in September 2017 after a project period of about three years. The project comprises 14 stations or stops, 3 interlocking locations, a remote link to the control centre, 106 main signals, 51 distant signals, 153 emergency signals, around 140 train stops and 49 points connections, 40 speed monitoring units, more than 200 axle counters and a control unit for weir chamber bulkheads (to seal off the Landwehrkanal, a canal in the area).
For this project, certitudo GmbH successfully carried out the validation of the safe interlocking logic of the electronic interlocking at Mehringdamm station in accordance with European CENELEC standard EN 50128:2011 so that BVG could commission this without any issues.
* Definition according to CENELEC standard EN 50128:2011