BPA modern apps for quality and medical compliance include many modules for risk planning with the objective to develop a preventive risk mindset for the organization. Our components are very flexible to adapt to any risk methodology and comply with ISO 14971 recommendations.
We introduced 2 levels of risks in our software. Point risk analysis (initial risk and residual risk assessment after mitigation) is done for nonconformities, changes, incidents and other modules. Continual risk analysis is performed for enterprise risks and high residual risks.
Initial and residual risk values for nonconformities.
The enterprise risk management module includes prebuilt automated workflows to provision risk values based on assessment frequency.
Enterprise risk portfolio with continual risk assessment values.
Let end users know about your risk methods with our configurable help panel.
Help panel with risk matrix and factors.
Medical hazards are periodically assessed with a risk class ranking and risk priority ranking.
Medical hazard details with potential hazard, risk class ranking and risk priority ranking.
Power BI reports display consolidated risk data in configurable dashboard.
GAMP 5 hazard report with Power BI.
Process and product risks are evaluated based on FMEA methodology. The tool is flexible enough to group FMEA risks is folders (e.g. by product) and copy/paste and update risks with the same agility as a spreadsheet.
Copying and assessing FMEA risks by using the grid mode.
As a conclusion, BPA apps and components provide agile components to adapt to your risk methodologies and regulations (ISO, internal control,…).
With Office 365, we propose a secure and robust platform for risk management, including prebuilt automated workflows, Power BI reports and instant discussions with Teams.