2026-08-13 –, Room 5
As the pharmaceutical industry shifts toward Model-Informed Drug Development (MIDD) and complex pharmacometric simulations, the Julia programming language has emerged as a frontrunner due to the availability of specialized ecosystem for Pharmacometrics (Through Pumas, SciML and JuliaDiff packages) and support for High Performance Computing, and interoperability.
However, deploying Julia in a GxP-regulated environment requires more than just efficient algorithms; it demands strict adherence to software validation, reproducibility, and data integrity standards such as FDA 21 CFR Part 11 and GAMP 5.
This talk outlines a strategic framework for making Julia code "pharma-ready." We explore the use of Julia’s native packages to maintain Reproducibility, the implementation of testing suites for the generation of validation reports and we will also explore how to use literate programming in Julia to generate documentation and reports . By leveraging Julia’s unique features, we show how developers can create high-performance workflows that satisfy both computational demands and regulatory scrutiny.
Non-compliant software cannot be used in the pharmaceutical industry because it directly compromises patient safety, data integrity, and product quality. In a highly regulated sector (e.g., FDA, EMA, WHO), software must undergo rigorous validation to prove it consistently operates as intended. Non-compliant, invalidated systems lead to legal, financial, and safety risks.
Achieving compliance in a regulatory setting isn't about the language itself, but the processes wrapped around it. To make Julia code compliant for pharmaceutical use, developers must focus on following aspects
Reproducibility:- Software reproducibility in the pharmaceutical industry refers to the ability of a computerized system to consistently generate, process, and output the same results, data, or product quality metrics whenever it is used, regardless of who is operating it or when it is operated. This is a critical component of GAMP 5 and makes sure software used in GxP (Good Practice) environments consistently adheres to FDA 21 CFR Part 11 and EU GMP Annex 11 regulations. In this talk, we will show how to ensure reproducibility in your Julia program using Pkg.jl and other external Julia packages.
Documentation:- We will show how to use literate programming in Julia using Literate.jl or Weave.jl to generate reports where code, assumptions, and results live in a single document.
Validation:- Regulatory bodies require proof that the software performs its intended functions. These proofs are provided in form of following reports
Installation Qualification (IQ) report: Provides evidence that the Julia app and its dependent libraries are installed correctly in the production environment.
Operational Qualification (OQ) report: Provides evidence that your Julia app operates correctly according to specifications and functional requirements.
Performance Qualification (PQ) report: Provides evidence that your Julia app operates consistently and reproducibly under routine, real-world conditions to meet predefined specifications, this report also includes a conclusion confirming the Julia app is ready for performing its routine production tasks.
In the talk, we will show you how to generate these pieces of evidence with respect to your Julia app and show an example of these reports.
All the recommendations that will be discussed in this talk; stem from eight years of developing and maintaining Julia-based solutions which were deployed in regulated pharmaceutical environments.
I am a Senior Software Engineer with 10 years of experience at JuliaHub. Over the past decade, I have transitioned from developing core Julia-based desktop products (JuliaPro, Pumas) to my current role on the Operations team, I specialize in developing, deploying, and maintaining robust Julia-based software solutions. My background includes collaborating with the Pumas team to streamline the build processes for the Pumas and DeepPumas JuliaHub apps.
Currently, I am a member of the operations team, where I manage deployments and upgrades for our enterprise clients. Alongside overseeing the broader platform release process (With respect to compliance), I actively develop and maintain the RStudio and WindowsWorkstation apps. I also work closely with the compliance team to ensure the JuliaHub platform meets the strict regulatory standards required by our pharmaceutical enterprise customers.