IBM Computerized System Validation CSV
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Validation
Management
Audits and
Assessments
Features and
Functionality
Documentation
supported
Reporting
Engineering Lifecycle Management for Computerized System and Equipment Validation
IBM Engineering for Computerized System Validation and Equipment consists of a set of Applications, which include Requirements Management (using IBM Engineering Requirements Management DOORS Next), Validation Management, and workflows deployable in Engineering Workflow Management. It also includes a DOORS project template for medical devices, which contains pre-defined DOORS modules that users can instantiate to deploy DOORS more quickly in projects required to comply with FDA QSR and FDA 21 CFR part 11 requirements. IBM Engineering Requirements Management DOORS Next modules contain a set of defined attributes for the various stages of development in the safety lifecycle, including specification, design, implementation, integration, verification, validation, and production release.
IBM Engineering for Computerized System Validation and Equipment consists of a set of Applications, which include Requirements Management (using IBM Engineering Requirements Management DOORS Next), Validation Management, and workflows deployable in Engineering Workflow Management. It also includes a DOORS project template for medical devices, which contains pre-defined DOORS modules that users can instantiate to deploy DOORS more quickly in projects required to comply with FDA QSR and FDA 21 CFR part 11 requirements. IBM Engineering Requirements Management DOORS Next modules contain a set of defined attributes for the various stages of development in the safety lifecycle, including specification, design, implementation, integration, verification, validation, and production release.
Validation & Testing
Test
planning
Linked to requirements
Comprehensive test plan
Scope, Timeline, Resources
Risk assessment
Test Construction
Requirement driven testing
Test enviroments coverage
Manual test authoring
Test lab management
Test
Execution
Manual test execution
Drive test automation tools
Record test results
Submit & Track defects
Reporting & Dashboard
Status and progress tracking
Customizable live dashboard
Compliance and quality audit
Real-time metrics and reports
Reporting & Dashboards
The IBM Platform provides out of the box several thousand reports which you can add to your personal, team or project dashboard.
For advanced needs you can create your report in WYSIWYG similar application called IBM® Jazz Reporting Service which provides very simple yet powerful reporting capabilities.
Ready-to-use reports that you can use to share information about your lifecycle management projects or you can create new reports. You can also export the report data to Microsoft Excel or integrate the reports with your dashboards
Ready-to-use reports that you can use to share information about your lifecycle management projects or you can create new reports. You can also export the report data to Microsoft Excel or integrate the reports with your dashboards
Features and ways how
we can help you to
achieve compliance.
Document Generation
IBM Engineering Lifecycle Optimization - Publishing (PUB) is an automated document generation solution that generates documents from IBM Engineering Lifecycle Management products and selected applications from other vendors that use XML and REST interfaces.
With Engineering Publishing, you can:
- Generate documents for everyday use, formal reviews, and compliance with standards
- Create multiple output formats in one generation, including Microsoft Word or Excel, HTML, PDF, and XSL-FO documents
- Schedule reports to run routinely
- Include data from multiple products in one report
- Store and reuse artifacts for any number of reports
- Get reports based on current data as frequently as you like
- Include a range of organization features in your report, such as a table of contents, captions, comments, and more
Failure Mode and Effects Analysis
IBM provides out of the box FMEA extension for IBM Jazz Platform which is installed in /RM component. Extension enables users to:
- Choose attributes like probability, severity, impact
- Automated or manual calculation of risk priority number (RPN)
- Linking of FMEA artifacts to affected requirements and to mitigation requirements
- Out of the box Gap Analysis
With help of Softacus FMEA extension we are also able to:
- Compare RPN before and after mitigation
- Color-code RPN based on the value
- Adjust the FMEA calculation to any of your needs
- Provide it for free to our IBM Jazz customers
Hazard Analysis
Fault Tree Analysis (FTA)
- Traceable links among requirements, Traceable links among requirements, analysis, design, and safety elements makes your “safety case”
- FTA elements can have traceable, navigable links to– Requirements– Elements that can manifest faults– Elements that can detect faults– Elements that handle faults
- FTA elements contain metadata– Severity– Likelihood– MTBF– Risk– Safety Integrity Level
- UML Fault Tree Analysis Profile
- Fault Means, Effect, and Criticality Analysis (FMECA)
– An inductive (bottom-up) approach that relates component faults with hazards
– Cannot be applied until you have a parts list, which is late in the development process - Security Analysis Diagram
– UML Profile for modeling cybersecurity, threats, and countermeasures
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