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Ensure Your R-based Computing Environment Meets Regulatory Compliance
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A comprehensive diagnosis of your R and Python code and scientific computing environment compliance with actionable recommendations and areas for improvement.
Increase Chances for Smooth FDA Submission
Code validation is critical for successful regulatory submissions. We help you improve workflows, implement secure practices, run tests, and ensure proper documentation.
Regulatory Confidence
We review your code and workflows against GxP standards, so your systems meet FDA and EMA requirements before submission.
4-6 Week Turnaround
Results delivered within a streamlined 4-6 week process covering 20 audit areas — from development practices to security and reproducibility.
Actionable Insights Report
You receive a detailed report highlighting risks, compliance gaps, and a clear step-by-step action plan to achieve GxP compliance.
How We Helped Our Partners
GxP Reporting Automation: from 5 Weeks to 5 Minutes
Reducing the time needed to generate Annual Product Quality Review (APQR) by 85% for a premier biopharmaceutical company's GxP compliance process.
What the Audit Covers
A structured review across 20 areas of your clinical data science environment.
Code
Code Quality Review
In-depth review of R and Python code against GxP development standards, covering structure, readability, and maintainability.
Security
Security Assessment
Evaluation of access controls, data handling, and infrastructure security to identify vulnerabilities and compliance risks.
Validation
Validation & Testing
Assessment of unit tests, integration tests, and performance benchmarks to ensure reproducible and reliable results.
Documentation
Documentation Review
Review of technical documentation, SOPs, and audit trails to ensure traceability and regulatory readiness.
Compliance
Compliance Gap Analysis
Systematic identification of gaps between current workflows and FDA/EMA requirements, with risk-prioritized findings.
Training
Team Training & Enablement
Targeted workshops to equip your clinical data science teams with GxP best practices and secure development workflows.
#Why Appsilon
Not just a vendor.
A force multiplier.
We bring ecosystem access, regulatory experience, and elite talent that compounds your capabilities.
Pharmaverse Council Members
We sit on the pharmaverse council, develop core packages, and contribute to the ecosystem. You gain access to our deep connections and collaborative innovation.
Proven with Regulators
Partnered with Eli Lilly and R Consortium on pilot FDA submissions. We know what regulators expect and how to deliver it with open-source tooling.
Real Pharma Experience
We've helped 8 of the top 10 pharma companies modernize their analytics workflows. We understand the regulatory constraints, organizational dynamics, and technical debt you're working with.
Core Open Source Contributors
Appsilon engineers serve as core contributors to the {teal} framework, sponsored by Roche. Our team shapes the tools your teams rely on.
How to Start Your GxP Audit
Code validation is critical for successful regulatory submissions. We help you improve workflows, implement secure practices, run tests, and ensure proper documentation.
Week 1-2
Kickoff & Scoping
Define audit scope, onboard into your systems, and review existing documentation and workflows.
Week 2-4
Deep Assessment
Code review, security audit, and workflow analysis across 20 audit areas covering development, validation, and reproducibility.
Week 4-5
Report & Action Plan
Compile findings into a comprehensive insights report with risk-prioritized recommendations and a step-by-step action plan.
Week 5-6
Training & Handoff
Targeted team training on best practices, implementation guidance, and setup for ongoing support.
#Valued by clients worldwide
#Contact Form
Consult with Our Experts for Custom Solutions
Get in touch
with Appsilon Experts
with Appsilon Experts
We will contact you within 24 hours!
#Our Clients About Appsilon
How It Feels to Work with Us
Appsilon team is exceptional. The engineers challenge and speak their minds, which helps do justice to the product.
Associate Director
Top 50 Pharma Company
We rely on Appsilon's expertise to support the build and maintenance of critical clinical reporting software based in R and Shiny.
Data Engineering Lead
Top 10 Pharma Company
We wouldn't be here where we are now without Appsilon. I want this partnership to keep going and growing.
Human Resources People Partner
Top 10 Pharma Company
Expert Insights
Insights, Inspiration & Distilled Knowledge
What is GxP Validation in Clinical Software Development?
Make FDA submissions and GxP validation easier with tips and best practices tailored for clinical software development.
Paweł Przytuła
Read more
Ebook for Directors in Clinical Trials
Get Your Copy Today
Explore how open-source technology, particularly R and Shiny, is transforming clinical trials and the broader pharmaceutical industry.
FAQs
Find clear answers to common questions about GxP compliance, helping you navigate regulations with confidence.
01.
What type of follow-up support is available after the audit?
Appsilon provides ongoing support including implementing audit recommendations, building SCEs, developing dashboards, and validating apps and packages.
02.
Are your experts available to implement the audit recommendations?
Yes, our team is available to assist with implementing recommendations and optimizing your processes as needed.
03.
How can your services assist with FDA/EMA submissions?
We help by setting up GxP-compliant environments, preparing documentation for audits, and ensuring data accuracy through testing.
04.
What kind of experts are assigned to the audit?
Senior architects review code and workflows, platform engineers evaluate infrastructure, and project managers compile comprehensive reports.
Contact Us
Drive Impact with Appsilon
From custom dashboards and applications to AI-powered solutions and compliant computing environments, our engineers and infrastructure architects accelerate clinical development within fully validated, regulatory-compliant frameworks.