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Digital Quality Metrics and AI/ML Analytics

Building a Continuous-Improvement Framework that Aligns with Regulatory Expectations

  • Carolyn Troiano
  • FDB2847
  • Carolyn Troiano
  • FDB2847
  • 90 Minutes Learning Time
This course equips teams to use AI/ML-enabled quality metrics as a controlled decision tool, strengthening early risk detection, data review, and compliance oversight while keeping human judgment central to quality outcomes.
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ONE participant (viewer) – Live session Plus Complimentary 30 Days Streaming access

Up to 10 participants – Live session Plus Complimentary 30 Days Streaming access

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Why take this course?

Digital quality metrics are becoming more important as life sciences companies adopt cloud services, SaaS platforms, AI, ML, and LLM-enabled tools across development, manufacturing, testing, and support activities. These technologies can improve speed and visibility, but they also introduce validation, Part 11, and data integrity concerns that cannot be handled through general IT oversight alone. When metrics pipelines, dashboards, and analytics influence quality decisions, companies need clear control over how data is generated, reviewed, and used.

This program focuses on building digital quality metrics that support continuous improvement while remaining aligned with FDA-regulated expectations. It addresses how risk-based metric selection, AI/ML analytics, and dashboard design connect to SDLC activities, GAMP®5 (Second Edition), CSV, and CSA. It also examines supplier-provided analytics, data integrity in aggregation layers, and the practical limits of AI, including hallucination, bias, and performance drift, where human judgment remains essential to sound quality and compliance decisions.

  • Build metrics that support earlier quality decisions:

    This course helps teams move from delayed reporting to digital quality signals that can identify trends, deviations, anomalies, and drift sooner. That improves how risk is recognized across GxP systems and supports quicker, better-informed action before issues expand into larger quality or compliance concerns.

  • Use AI/ML analytics without losing compliance control:

    AI and ML can increase efficiency, but they also introduce risks tied to unreliable data, hallucination, bias, and shifting performance. This course strengthens how teams apply analytics within validated environments, maintain data integrity, and use human review as the guardrail for quality, compliance, and better judgment.


Key Areas Covered

  • Moving from lagging indicators to real-time digital quality signals
  • Selecting quality metrics for GxP systems using risk-based quality principles
  • Using AI/ML analytics to detect trends, deviations, anomalies, and drift earlier
  • Building dashboards that support data integrity, electronic records, and risk-based decisions
  • Connecting analytics to SDLC activities and GAMP®5 (Second Edition) control strategy
  • Verifying supplier-provided analytics and understanding what FDA expects companies to assess
  • Managing hallucination, bias, and performance drift in AI-enabled quality solutions
  • Presenting digital quality metrics during regulatory inspections and audits

This Course is designed for professionals responsible for validation, data integrity, quality metrics, or oversight of AI-enabled systems in regulated operations.


A must for Quality, Information Technology, Manufacturing, Automation, Regulatory Affairs, Clinical Trial, Laboratory, and Computer System Validation Professionals.

COURSE DIRECTOR

Carolyn Troiano

Carolyn Troiano has more than 45 years of experience in computer system validation across FDA-regulated industries and advises companies on FDA compliance, CSV, and large-scale IT implementations. She also participated in the FDA/Industry Partnership that developed 21 CFR Part 11, bringing directly relevant experience in electronic records, data integrity, and validated digital systems.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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