Process Risk Assessment: A Data-Driven FMEA Approach



How Graphtal Supports Process Risk Assessment and FMEA:

Historical Data Integration: We analyze past bioprocess data to identify trends, deviations, and variability.

    FMEA Tool Facilitation: Provides tools and expertise to systematically conduct bioprocess-specific Failure Mode and Effects Analysis.

      Potential Critical Process Parameter Identification: Detects key  parameters that impact  product quality and process robustness.

        Predictive Machine Learning: Applies ML to forecast deviations and improve decision-making based on historical patterns.

          Multivariate Data Analysis (MVDA): Uncovers complex relationships between process variables using statistical modelling.

            Training & Capability Building: Offers hands-on training and support to strengthen internal risk and data analytics competencies.


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