• Agree and manage the requirements
  
• Agree and manage the interfaces
  
• Prepare the test and support systems
  
• Track progress against a plan

The solution contains predefined Modules:

• Generic Test plan/Test specification and Template for the Test report according to EN50128
• Generic Validation plan and Template for Validation Report according to EN50129
• Generic Safety plan and Template for Proof of Safety according to EN50129

Compliance with EN 50128

The software safety standard EN 50128 originates from the European Committee for Electrotechnical Standardisation or CENELEC. Its full title is ‘Railway applications. Communications, signaling, and processing systems. Software for railway control and protection systems. The internationally published version of the CENELEC EN 50128 standard is IEC 62279. The content of both publications is identical.

The standard requires that all systems with safety implications and which contain software should be assigned a Software Integrity Level (SIL), ranging from a value of 0 to 4. The standard then details in a number of ‘normative’ and ‘informative’ ways, the software development activities appropriate to each SIL that should be carried out, and evidence for the completion of which should be generated.

Rhapsody Kit for EN 50128

Documentation for the Rational Rhapsody Kit for ISO 26262, IEC 61508, IEC 62304, and EN 50128Rational Rhapsody Kit for ISO 26262, IEC 61508, IEC 62304, and EN 50128

IBM Rational Solution for Rail Engineering - CENELEC EN 50128 (beta)

The IBM Rational Solution for Rail Engineering - CENELEC EN 50128 is a set of best practices to help organizations develop products for certification under the EN 50128 safety-critical standards. The scope of these practices covers the objectives, plans, tasks, and work products described and specified by the EN 50128 standard They have been developed to support incremental adoption, thereby accelerating the adoption of common process support, practices and tools so as to reduce the time to value for the client’s process improvement initiatives. More information.

You can download the process asset here.

 

 

Solution Highlights

Automate Risk Management and Compliance

• Workflow control of individual work items enables streamlined, interdependent processes
• Linking of work items delivers full traceability throughout the lifecycle and across projects
• Comprehensive, automated history of all artifacts facilitates proof of compliance - Integrate risk management processes leveraging the ISO 14971 Template

Quick-Start with Automated Industry Processes

• Proven medical processes including the above customizable templates help get you started
• Automated workflow control includes routing, approval, and escalation
• Support for unlimited, fully linked variants speeds up development

Synchronize Collaboration In Real Time

• Centralized 100% browser-based tool drives real-time collaboration
• Online “easy-as-Word” authoring speeds up adoption
• DOORS NG Round-trip™ for Microsoft^® Excel^® smooths external exchange
• Native RIF/ReqIF exchange with IBM^® Rational^® DOORS^® etc. connects specialists

Automate Your Validation and Verification (V&V):

V&V is supported via comprehensive traceability, automated forensic-level accountability, and real-time reporting throughout the lifecycle as well as across projects.

Furthermore, it is supported via review and approval of any work item with an electronic signature, combined with uninterrupted traceability starting at the design phase.

Benefits for Development Manager

Unlock Complexity and Streamline Processes

• Get started quickly using Rational Team Concert work items and workflows and intuitively customize them to reflect unique company processes
• Enforce workflows in the product development process using the sophisticated rules engine
• Seamlessly integrate ISO standards and SOP requirements into product requirements
• Manage QMS documents in Rational Quality Manager for full traceability and easy proof of compliance
• Leverage generic Medical Device traceability tables

Automate Proof of Compliance

• Leverage RQM’s compliant electronic signature functionality for FDA 21 CFR Part 11
• Fully integrate company product design controls
• Easily set up automated traceability across design, manufacturing, and testing
• Plan user management and improve release predictability

Extend and Reuse Your Work

• Integrate Requirements with Verification and Validation (Design V&V) processes
• Drive requirements into Manufacturing
• Integrate the design Master Validation Plan
• Execute flawless design transfer
• Accelerate external exchanges with DOORS NG Round-trip^™ and native RIF/ReqIF

Benefits for Quality Managers

Automate Proof of Medical Device Compliance

• Leverage RQM’s compliant electronic signature functionality for FDA 21 CFR Part 11
• Full integration of company product design controls
• Very specific requirements traceability including integration with design, manufacturing, and testing traceability
• Predictable user management and integrated workflows

Create and Manage your company SOPs in IBM CLM

• Quickly construct a QMS traceability table
• Easily integrate SOP requirements with product requirements
• Benefit from managing all QMS documents in IBM CLM for multi-directional traceability
• Effectively plan for and manage internal audits

Help your development group manage complexity

• Integrate ISO standards with product requirements
• Establish a Medical Device comprehensive traceability table
• Easily enforce workflows in the product development process

Extend and Reuse Your Work

• Integrate Requirements with Verification and Validation (Design V&V) processes
• Drive requirements into Manufacturing
• Integrate the design Master Validation Plan
• Execute flawless design transfer
• Accelerate external exchanges with DOORS NG Round-trip^™ and native RIF/ReqIF

Enabling the generation of MISRA C/C++ compliant code

ALM Benefits

IBM CLM gives organizations one unified solution that delivers project transparency through real-time aggregated management information. Everyone is aligned around what is being built and why to drive advancement while protecting integrity and compliance. This helps teams respond faster and with better quality to new business opportunities and customer demand.

Immediate Benefits and Value

• Unlock synergies across all collaborators with 100% browser-based access to a single data source
• Increase productivity with an intuitive and role-based user interface
• Achieve better quality and regulatory compliance through end-to-end traceability and automated audit trails
• Adopt modern agile techniques at once or incrementally with out of the box project templates that can be adjusted to your needs
• Optimize planning, prioritization, and release predictability via flexible planning and real-time reporting