Recently, I was doing some in-depth research on GxP guidance and automated system validation, and I decided to compile everything I learned into a complete study guide / ebook for anyone looking to get started with GxP and GAMP 5.
Whether you're new to life sciences compliance or just curious about how enterprise data tools fit into regulatory frameworks, I wanted to share this resource with the community!
Here is a quick overview of what the guide covers:
The History & Core Pillars of GxP: Traces how regulatory rules evolved after real-world disasters and covers the fundamentals of GLP, GCP, GMP, and GDP.
GAMP 5 Software Categorisation: Explains how software is categorized from Category 1 (Infrastructure) up to Category 5 (Custom/Bespoke Software).
Posit Ecosystem Mapping: Provides real-world examples of how Posit products fit into GAMP categories—including base R/Python runtimes (Cat 1), Posit Workbench (Cat 3), Posit Connect and Package Manager (Cat 4), and custom Shiny apps or R/Python analysis scripts (Cat 5).
The 14 Core Validation Documents:** Breaks down essential validation lifecycle paperwork, including Validation Plans (VP), User Requirements Specifications (URS), Configuration Specifications (CS), functional testing (IQ/OQ/PQ), Requirements Traceability Matrices (RTM), and Change Control.
I’ve attached the GxP & GAMP Complete Study Guide PDF below. I hope this serves as a helpful roadmap or quick reference for anyone working with Posit tools in regulated environments!
Feel free to check it out, and I’d love to hear your thoughts or how your team handles validation in your own workflows!
<iframe src="https://www.linkedin.com/embed/feed/update/urn:li:ugcPost:7488831370987847680" height="465" width="504" frameborder="0" allowfullscreen="" title="Embedded post"></iframe>