Cosylab | codeBeamer ALM as a Swiss Army Knife on a Particle Therapy Project
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The document outlines the capabilities and achievements of Cosylab, which specializes in software for radiation therapy and scientific applications. They have successfully delivered over 250 projects globally with significant growth, employing nearly 200 skilled developers since their establishment in 2001. Key features of their software include enhanced documentation, risk management functionalities, and support for various scientific and medical device workflows.
Cosylab | codeBeamer ALM as a Swiss Army Knife on a Particle Therapy Project
- 1. THE GLOBAL LEADER IN SOFTWARE FOR RADIATION THERAPY AND SCIENTIFIC APPLICATIONS Jernej Plankar Medical Systems Engineer codeBeamer ALM as a Swiss Army Knife on a Particle Therapy Project
- 2. About Cosylab NEW ENERGY BIG PHYSICSSPACE AND ASTRONOMY We develop control systems for • Particle therapy facilities (PT) • Large scientific facilities (accelerators, fusion, telescope arrays, etc.) Numbers • Branches: Europe (3), US, China, South Korea, Japan • Established in 2001, >20% CAGR, turnover > 17.5 M€ in 2019 • Nearly 200 highly-skilled developers and engineers • 250+ successfully delivered projects in 20 countries CERN Large Hadron ColliderITER The Extremely Large Telescope (ELT) PARTICLE THERAPY MedAustron Particle Therapy Centre INDUSTRY 4.0 Manufacturing, robotics…
- 3. About Particle Therapy Depth Dos e 100 % Ideal dose distribution Malign tumour Photons (radiotherapy) Source
- 4. About Particle Therapy Depth Dos e 100 % Ideal dose distribution Malign tumour Source Particles (protons, ions)
- 5. What do you use codeBeamer for?
- 6. The codeBeamer Use Cases • Requirements • Tests • Risks • Documents • Bugs (problem reports) • Change requests • Releases • Software unit verification workflow (code review, unit testing...) • Software of unknown provenance (SOUP) • Input control and parts traceability (HW) • Tool validation • ...
- 7. Why? • Work process is implicitly followed by pre-defined workflows • Easier for team members to get on board • Less ″brainless″ documentation tasks • More analysis, requirements engineering, coding, testing... => increased quality • Inherent traceability • Who has done what and when? • How does it relate to other items? => easy change impact analysis • Development process is unified over entire company
- 8. How? • A set of configured trackers, based on MDR and applicable med. dev. standards • Trackers are used to create and manage content, based on lifecycle processes • Ensuring traceability between correlated parts as well as chronologically • Inherent DHF and DHR formation (electronic records)
- 9. Use case: Documentation (1) Profile Content Stored in CodeBeamer (Documents Tree) Title, Unique ID, Revision, Authors, Reviewers, History, Link to the content... Anything/anywhere, e.g. • codeBeamer tracker (Reqs, Tests, etc.), • A .doc file, stored in arbitrary repo (cB/SVN/Git/...) • Paper document • Website • ... Document The export template generates documents ready for release by combining the information from the Profile and Content.
- 10. Use case: Documentation (2) • Documents Tree = a centrally managed list of all planned and created documents (profiles) • Auto team notification • Release workflow • Compliant with ISO 13485
- 12. Use case: Risk management (1) • Hazard • Hazardous situation • Failure mode • CAPA • SOUP item • ... Risk Risk control measure Requirement Test case Analysis & Evaluation Mitigation Implementation Verification • Compliant with ISO 14971
- 13. Use case: Risk management (2)
- 14. Use case: Risk management (3)
- 15. Use case: Third-party software – SOUP & OTS
- 16. Use case: Input control
- 17. Use case: Technical File Template
- 18. How it all fits together