Qualification Framework
Follow a defined series of questions, actions and instructions for tool-performance validation.
Simplify Tool Qualification and Compliance Audits
Visure Tool Qualification Package
Use a structured package of project documents, questions, actions and instructions to validate tool performance and generate qualification records for regulated development environments.
PurposeTool qualification
FormatStructured project documents
OutputValidation records
UseRegulated development
Capabilities
Core Capabilities
Capabilities and terminology aligned to the current partner portfolio and target application.
System Requirements
Document the tool and environment requirements that form part of the qualification activity.
Validation Activities
Execute and record validation steps within the controlled package.
Qualification Report
Generate a record showing that the defined qualification activities have been completed.
Controlled Software Updates
Support qualification strategies that avoid unnecessary re-validation when the deployed software baseline is intentionally maintained.
Audit Support
Organize tool-qualification evidence for regulated project audits.
Standards & Compliance
Standards and Regulatory Context
Relevant standards, coding guidelines and assurance frameworks for the technology and its application areas.
DO-178C tool qualification context
DO-254 tool qualification context
IEC 62304 project context
ISO 26262 project context
FDA regulated workflow context
Industries
Industry Applications
Industry connections are included where the technology addresses a defined engineering, verification or product-security requirement.
Integrations & Deployment
Toolchain and Deployment
Connect the technology with the existing engineering environment, lifecycle tools, CI/CD platform and target architecture.
Platform
Visure Requirements ALM
Qualification content
System requirements, validation steps and reports
Governance
Use according to the applicable project/tool-qualification plan