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Not only compliant, but reliable.
In industries where safety is non-negotiable, Validas ensures your systems meet the highest compliance standards specific to your domain.
Organizations in highly regulated industries must navigate the complex challenge of complying with stringent safety and security standards that govern the development and deployment of critical systems.
These standards are designed to ensure functional safety, cybersecurity, and reliability across various sectors, each with its own specialized requirements.
ISO 26262 ensures functional safety in road vehicles, forming the backbone of safety assurance in the automotive sector. Complementing it, ISO/SAE 21434 addresses cybersecurity risks throughout the vehicle lifecycle, from design to decommissioning.
IEC 61508 provides a comprehensive framework for functional safety in industrial automation, covering electrical, electronic, and programmable electronic systems used in critical applications.
IEC 62304 defines the software life cycle processes for medical devices, emphasizing risk management, structured development, and ongoing maintenance to ensure safe and effective operation.
DO-178C and DO-330 are foundational standards in avionics and aerospace, governing software development and tool qualification to guarantee the safety and reliability of airborne systems.
EN 50716 governs cybersecurity for communication and signaling systems in the railway domain, ensuring secure and resilient infrastructure for safe rail operations.
To adhere to those compliance standards, Validas applies its innovative Compliance and Safety Framework (COSAFE), which facilitates the creation of Qualification Kits (QKits) for the continuous verification and qualification of tools and libraries.
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FAQ
The difference between tool classification and qualification: Tool classification determines the tool's impact on a safety-related product. Qualification is the subsequent process of gathering evidence to demonstrate that a tool is suitable for its intended use.
Tool qualification is required by most major functional safety standards, including ISO 26262 (Automotive), IEC 61508 (Industrial), IEC 62304 (Medical), DO-178C (Avionics), and EN 50716 (Railway).
A Qualification Kit (QKit) is a pre-packaged collection of documents, test cases, and procedures that automates and streamlines the tool qualification process, saving time and effort by providing pre-built frameworks.
No, only tools that have an impact on the safety-related outcome of the project need to be qualified. This is determined during the tool classification process.
Yes, but open-source tools and libraries must be qualified for their intended use. Validas AG provides the expertise, methods, and Qualification Kits to make this process efficient and compliant, ensuring safe adoption and compliant use of open-source tools in your project.