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ISO 14971 Risk Management ISO 14971 Risk Management
TurboAC™ RMF: electronic ISO 14971 compliant risk management file
- Intuitive compliance with ISO 14971 and FDA requirements
- Built-in toolkit for Fault Tree Analysis (FTA) graphic
- Built-in toolkit for Failure Mode and Effect Analysis (FMEA)
- Full connectivity between FTA and FMEA
- Automatic calculation of residual risk of each hazard and cause
- Centralized links to the supporting documents/information (evidence)
- Highly customizable risk analysis traceability matrix
- Total Product Life Cycle (TPLC) management
- Electronic records and signatures
- Plug ins for connectivity with other requirement management tools (e.g. DOORs)

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ISO 14971 Safety Assurance Case ISO 14971 Safety Assurance Case
TurboAC™ Assurance Case:  all in one solution for safety assurance case development

 

- Tabular, graphic, and narractive safety assurance case editors

 

- Able to convert the tabular or XML format safety assurance case into graphic HTML file that can be viewed and navigated using a web browser

 

- Able to convert existing risk management information into a safety assurance case table or graphic

 

- Integration of risk management and safety assurance case throughout the product life cycle

 

- Intuitively guides you to provide additional information that is needed for a robust safety assurance case

 

- Able to print on regular size paper

 

- Electronically submit the safety assurance case to FDA

 

 

TurboAC™ Evidence: requirements, test cases, CAPAs, Complaints etc.
- Traceable indiviual requirement, test case, CAPA, Complaint etc.
- Tabular, graphic and narrative editors
- Export to word or PDF
- Full traceability among requirements, design specifications, test cases, and CAPAs
- Full connectivity with TurboAC risk management and safety assurance case moudles
- Life cycle change management

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ISO 14971 Risk Management and Assurance Case ISO 14971 Risk Management and Assurance Case