<img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=489233&amp;fmt=gif">
Search

    Quality Outlook 2026: The Rise of the QA Agents

    The case for a human-led, AI-enabled future for quality

    Download the Quality Outlook 2026
    Global Quality Outlook 2026 cover | Scilife

    Not another report about AI

    In a world saturated with AI narratives, Quality Outlook 2026 focuses on what actually determines success in life sciences: the people behind the systems.

    It examines how QA leaders are evolving into data-literate, digitally fluent decision-makers — the human agents who interpret risk, guide technology, and protect trust as complexity accelerates.

    Illustration of hands holding 2026 report | Scilife

    The state of the industry

    As AI adoption accelerates, gaps in quality, maturity, and human oversight are becoming more visible, precisely as regulatory scrutiny increases.

    Digital ambition outpaces operational reality in life sciences organizations

    • 48%¹ of leaders see digital transformation as a major strategic driver
    • Only 14%¹  report full integration of AI into daily workflows
    • Only 22%¹  of organizations reported having successfully scaled AI

    Regulation moves to the forefront, compliance comes under strain

    • 50%² increase in FDA warning letters in fiscal year 2025
    • Product recalls in the EU and UK rose by +10.2% YoY³
    • CoPQ  (Cost of Poor Quality) = 15–20% of revenue⁴

    Quality maturity remains uneven, with wide disparities across regions and sectors

    • 20%⁵ encounter leadership resistance to quality initiatives
    • 40%⁵ struggle to make data-driven quality decisions
    • 58%⁵ of companies lag in quality digitalization

    Quality is becoming digital. Trust is still human.

    Digital wireframe human head representing digital quality | Scilife

    The reality

    AI is everywhere. Regulations are tightening. Data is exploding.

     

    Yet life sciences organizations are still paying the price for reactive quality: delays, remediation costs, fractured systems, and eroded trust.

     

    The question isn’t how fast we can automate quality — it’s how we do it without losing human judgment.

    Classical human statue head with a checkmark representing human trust | Scilife

    The reality check

    The future of quality isn’t about AI replacing people.

     

    It’s about QA leaders evolving into QA Agents: professionals who combine data, digital systems, and AI with context, ethics, and accountability.

     

    They don’t just ensure compliance. They interpret risk, guide technology, and protect patients.

    What is in this report?

    Based on insights from hundreds of quality professionals across life sciences, this report combines real-world data, expert perspectives, and practical guidance for QA leaders preparing for 2026.

    The rise of QA agents cover | Scilife
    Foreword of global quality outlook 2026 | Scilife
    Index of the Global Quality Outlook 2026 | Scilife

    Inside the report, you’ll find:

    • An evidence-based assessment of quality maturity across life sciences organizations
    • Real data on how culture, leadership, and data gaps limit even the best QA teams
    • Why digital quality systems only work when guided by human judgment
    • How to move beyond compliance toward more resilient, capability-driven quality models

    Authors, experts, and contributors

    Their insights shape the practical strategies throughout the report.

    Sebastien Sepierre,
    CEO, Scilife

     

    Angel Buendía,
    Knowledge Manager, Scilife

     

    Lesley Worthington,
    Communication and Leadership Coach

     

    Chris Martin,
    Quality Specialist, RP, RPi & GDP Expert

     

    Karandeep Badwal,
    Founder and Principal Consultant at QRA Medical

     

    Martin King,
    Regulatory Affairs and Quality Assurance expert

     

    Georg Digel,
    Founder at Elevate CAPA

     

    Download the Quality Outlook 2026