DigitizeControlValidateyour lifecycle management process with the best CSV Solution provided by Softacus

Upgrade your old-school software validation methods and enjoy a paperless, error-free, and automated lifecycle management process. Spend more time on value-added activities with our professional IBM Validation Lifecycle Management System.

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Find all that you need in one place

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Validation
Management

IT System Risk Analysis
Register Management
Re-Qualifications
Periodic Reviews
Change Controlling
Risk Management
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Audits and
Assessments

Computer System Audit
21 CFR Part 11 Signatures
System Impact Assessment
Risk Assessment
Decommissioning
Testcase Execution
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Features and
Functionality

Requirements Management
Real-Time Documentation
Traceability Management
Dynamic Data Sharing
Status Monitoring
Protocol Authoring
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Documentation
supported

Validation Master Plan &
Reporting
Design Documents (FS, URS, CS, DDS, etc.)
Test Protocols (FAT, SAT, IQ, OQ, PQ/UAT, etc.)
Operational Forms & Logbooks

Engineering Lifecycle Management for Computerized System and Equipment Validation

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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

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Traditional & agile practices & methods
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Reuse of requirements and tests
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Development lifecycle traceability
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Automation of Compliance and Documentation
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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

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Test
planning

Linked to requirements

Comprehensive test plan

Scope, Timeline, Resources

Risk assessment

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Test Construction

Requirement driven testing

Test enviroments coverage

Manual test authoring

Test lab management

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Test
Execution

Manual test execution

Drive test automation tools

Record test results

Submit & Track defects

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Reporting & Dashboard

Status and progress tracking

Customizable live dashboard

Compliance and quality audit

Real-time metrics and reports

Reporting & Dashboards

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Dashboards

The IBM Platform provides out of the box several thousand reports which you can add to your personal, team or project dashboard.

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Free Jazz Reporting Service App

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.

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Ready to use Reports, current and historical

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

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Report on anything

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

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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

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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)

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  • 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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Explore professional IBM computerized system validation tool which supports your projects in all project phases

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