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Guides

The long-form guides, one question each.

  1. A row of rubber stoppers lit cool above and warm below
    October 8, 20267 min read

    Agentic AI in GxP environments: A practical guide

    What does it take for AI agents to do useful work in a GxP environment, and what controls should a quality organization expect?

    In this guide
    1. What FDA's draft AI guidance asks for, and what it leaves out
    2. EU GMP Annex 22 and the revised Annex 11: what the drafts ask of AI systems
  2. A helix of light
    September 23, 20265 min read

    A modern guide to pharmaceutical deviation investigation

    How can pharmaceutical teams assemble evidence, investigate possible causes, and prepare a traceable deviation record faster?

    In this guide
    1. Why unstructured records slow regulated operations
  3. Tubes in a rack, close
    September 15, 20269 min read

    The complete guide to pharmaceutical document digitization

    How can pharmaceutical teams turn operational documents into accurate, structured, source-linked data that holds up in regulated work?

    In this guide
    1. True copies, scanned batch records, and data integrity
    2. How to digitize certificates of analysis from suppliers
    3. How to digitize paper batch records without losing the source
Highly Regulated

A weekly letter from Katalyze.

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