An assurance case is rarely created in one go. The argument matures with the system: it is developed, commented on, supplemented, reviewed and corrected, and each of these steps requires the time and effort of experienced engineers. Below, we show how this cycle can be accelerated by using AI tools connected to PREMIS via MCP. […]
Auditability is an important aspect of systems used in critical industries, such as automotive, energy, aviation or pharmaceuticals. In the latter, the term audit trail is used, which means an automatically created and secured record of the history of activities performed in the system. PREMIS implements audit trail records in accordance with the ALCOA+ principles, […]
PREMIS implements a goal-oriented approach, which is effective in achieving and controlling compliance with regulations such as the CRA (Cyber Resilience Act). Achieving cyber resilience requires coordinated processes and maintaining the consistency and currency of many of their results as evidence of compliance. PREMIS makes this easier. There is no substitute for an efficient technical […]
Space systems are developed using rigorous processes. In Europe, these are most often in accordance with ECSS (European Cooperation for Space Standardization) standards. These standards describe processes that ensure a high level of safety and reliability in the execution of missions. While the use of assurance cases is not explicitly required by ECSS standards, they […]
Regulations and standards in some industries require an organization to maintain readiness for control, audit, or inspection. Examples include GMP (Good Manufacturing Practices) in the pharmaceutical industry, MDR (Medical Device Regulation) for medical devices, and more recently the AI Act for high-risk AI systems. Maintaining inspection readiness requires coordinated cooperation between the relevant units, and […]
The accuracy and thoroughness of documentation are crucial for system certification. While the use of AI can accelerate the preparation of such documentation, it can also impact its quality. How can such documentation be effectively reviewed when it is extensive? It is important that information is presented in a way that makes it easy for […]
Certification of AI systems is a complex process that includes both AI regulations and industry regulations. In particular, the AI Act Regulation (EU 2024/1689) defines the concept of high-risk systems for which additional requirements have been defined. For such a complex process, the use of assurance case gives the opportunity to effectively manage the development […]
An assurance case used in a systematic and professional manner can not only be useful for system certification, but also as a communication tool in the system assurance process helping in early detection of problems and decision-making. Its effectiveness stems from its focus on goals and building confidence. However, this can be lost if you […]
The use of CI/CD tools (Continuous Integration and Continuous Delivery/Deployment) is increasingly common in the development of critical systems. The same CI/CD pipelines can also be used to automate the creation and maintenance of assurance cases including the argument structure and evidence, and also for the argument verification and status data updating. CI/CD process and […]
Eliminative argumentation is an alternative approach to building an assurance case. The argument is typically constructed positively and focuses on demonstrating why we believe the goal has been achieved. Eliminative argumentation relies on the constant questioning of “what if?”. The structure of the argument can be quite similar to that of a standard positive argument, […]
Safety cases are usually based on functional safety arguments to demonstrate that failures will not result in hazardous situations. But accidents may have causes related to the system behaviour different than failures. This is where SOTIF comes in. This stands for Safety of the Intended Functionality. What does it mean? It covers mitigation of hazard […]
When working with assurance case arguments, a simple text argument format can be useful. This should be understandable to humans and usable with AI tools, while also being formally defined so this can be imported into assurance case editors. For this purpose, we are introducing LTAC – Lightweight Text Assurance Case. It’s a simplified text […]