Risk summary report (or risk summary matrix) is a document commonly needed for Pre-market submissions or regulatory audits or inspections. The report typically includes traceability from hazards to causes, risks, risk controls, and artifacts such as requirements and/or V&V for the risk controls. Creating and maintaining this traceability can be tedious.


With TurboAC™, the user can electronically organize and centralize these artifacts and maintain it through the product life cycle.


Hazard Category

Hazard

Hazardous Situation

Harm

Sequence of Events

Cause

Risk Control

RBA Ref.

Req

Verification of Implementation

Verification of Effectiveness

Sev.

Pro.

Risk

Sev (M)

Pro

(M)

Risk (M)



















GessNet™ also provides support to develop connectivity interface with other electronic systems such as requirement and/or test case management tool.