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

11. Exported
Documents

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 

19. Presenter’s Name
Title
QUESTIONS?

20. Presenter’s Name
Title
jernej.plankar@cosylab.com
Web: www.cosylab.com
THANK YOU!