Connected risk management. Clear safety assurance.
TurboAC is GessNet’s established software for organizing hazard analysis, FMEA, risk controls, verification evidence, risk-management files, and safety assurance case content through the product lifecycle.
Structure for the risk work regulated products require
TurboAC keeps analyses, controls, and evidence connected rather than scattered across spreadsheets and standalone documents.
Hazard analysis
Identify hazards, hazardous situations, potential harms, use conditions, and relevant causes.
Risk-control implementation and tracking
Define risk controls, assign responsibility, and track implementation and verification status.
FMEA support
Structure failure modes, causes, effects, and relationships at system, subsystem, and component levels.
Verification and validation evidence linkage
Connect risk controls and requirements to evidence demonstrating that controls are implemented and effective.
Safety assurance case construction
Build claim, argument, context, and evidence structures for transparent review.
Lifecycle and change management
Maintain risk and assurance information as the design, manufacturing process, use environment, and field information evolve.
Two directions of analysis, one traceable risk picture
Top-down hazard analysis and bottom-up failure analysis should inform the same set of risk controls, requirements, and evidence.
Hazard analysis
Start from intended use and reasonably foreseeable misuse to identify hazards, hazardous situations, and potential harms.
FMEA and reliability analysis
Start from failure modes at system, subsystem, and component levels and evaluate how failures may contribute to hazardous situations.
From setup to reporting
A consistent structure supports initiation, execution, maintenance, review, and reporting.
Organizational setup
Establish roles, structures, templates, and conventions for risk and assurance work.
Risk-management file initiation
Define the product, intended use, applicable scope, and initial analysis framework.
Lifecycle management
Maintain hazards, FMEA, controls, evidence, and decisions through development and change.
Analysis and reporting
Produce reviewable risk-management and assurance outputs according to the configured process.
Safety assurance experience became the foundation for a broader connected platform
Following FDA CDRH OSEL’s introduction of safety assurance cases for infusion pumps in 2010, GessNet proposed and developed TurboAC in 2011 through close communication with OSEL. That work reinforced a central principle: regulated-development software must be built around the real relationships and decisions behind the documents.
Broader scope in QMSpace
QMSpace extends connected reasoning into requirements, CQAs, quality systems, systems engineering, product platforms, digital libraries, workflows, regulatory submissions, and lifecycle change.
Determine whether TurboAC or QMSpace is the better fit
GessNet can review the intended use, current environment, required analyses, deployment needs, and future scaling objectives.