GxP in Software Development

GxP Validation and Compliance for Pharma

We will ensure high quality of your software, so you can seamlessly go through FDA / EMA submission process.

astellas
Genmab
merck
johnson and johnson
World Health Organisation
Kenvue
Phuse
Pharmaverse
astellas
Genmab
merck
johnson and johnson
World Health Organisation
Kenvue
Phuse
Pharmaverse
What You Gain

Overcome GxP Challenges with Expert Support

Focus on advancing drug development while we ensure your software and technology meet the required GxP regulations. We manage audits, train your team, automate testing, and prepare your software for submission, keeping your systems GxP compliant and allowing you to concentrate on clinical trial success.

Quality and Compliance

We guarantee high-quality code and strong security, so your systems run smoothly and meet regulations.

Fast Implementation

Our ready-to-use tools speed up development, saving you time and keeping your company competitive in the pharma market.

Scientific Innovation

With biotech and software engineering expertise, we address your unique challenges, helping you drive innovation in clinical development.

Scalable and Custom Solutions

You can start with an audit or development support, and scale up as your needs grow, giving you full flexibility.

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.

50%

Reduction in manual reporting, allowing teams to focus on high-value tasks.

85%

Automation of GxP reports, improving accuracy and compliance.

Our Services

Guiding You Through GxP Compliance

We help companies navigate the complexities of GxP compliance, ensuring fast adoption of technology and meeting regulations efficiently.

"The team was able to get up to speed with a very complex project quickly and make strategic and novel improvements."

Sarah Gasman - Senior Data Analyst

Boston Medical Center

Conduct a comprehensive analysis of your software compliance and receive a detailed report with actionable recommendations and areas for improvement.

Train your team with best practices in version control, ensuring, ensuring your software aligns with industry standards.

Set up testing infrastructure, automate manual testing to significantly speed up validation, and train your team to maintain automation.

Develop GxP-compliant dashboards that provide real-time insights, ensuring accurate data visualization and compliance support.

Build validated environments for cloud, operations, data management, ML, AI, and engineering, ensuring compliance and reproducibility.

Our Expertise

Your GxP Compliance Partner

With over a decade of experience and world-class engineers, we bridge the gap between software development and successful drug development.

World-Class Engineering Talent

Our team consists of the top 1% of software engineers globally, bringing unmatched expertise in developing GxP-compliant software for biotech and pharma.

Partners to 7 out of Top 10 Pharma Companies

We’ve successfully delivered hundreds of projects for top biotech and pharma companies, providing the technical foundation for clinical trials and drug development.

Dedicated DoD and AQT Processes

Our proprietary Definitions of Done (DoD) and Appsilon Quality Test (AQT) processes ensure that your software meets the highest standards of GxP compliance.

astellas
Genmab
merck
johnson and johnson
Phuse
Pharmaverse
astellas
Genmab
merck
johnson and johnson
Phuse
Pharmaverse
Tools and Technologies

Leveraging the Best Technologies

We combine cutting-edge technology with scientific expertise to deliver high-quality, compliant solutions.

Languages
R Language
JavaScript
Python
Cloud
Google Cloud
AWS
Azure
On-Premise
Frameworks
Shiny
PyTorch
React
NextFlow
Ansible
Observable
Platforms
Databricks
Docker
Kubernetes
shinyapps.io
Package Manager
Posit Connect

Is Your Software GxP Compliant?

Download a checklist designed for clinical managers in data departments to make sure that software meets requirements for FDA and EMA submissions.

Get the Checklist
Our Clients About Appsilon

Helping Pharma Teams Like Yours Achieve GxP Compliance

"The team was able to get up to speed with a very complex project quickly and make strategic and novel improvements."

Sarah Gasman, Senior Data Analyst

Boston Medical Center

"[Appsilon] is able to understand project needs and to develop innovative solutions that we had not previously envisioned."

Robin Whytock, Research Fellow

University of Stirling

"We explored how machine learning and advanced analytics could help automate processes, uncover new insights, and achieve outcomes beyond traditional approaches."

Bill Adams,

Boston Medical Center

Talk to Our Experts

Get Custom GxP Compliance Guidance

Appsilon Experts
Schedule a call with our GxP expert, to discuss your specific challenges and compliance needs.
Paweł Przytuła
CRO at Appsilon
We will contact you within 24 hours!
MerckWHOJnJkenvue
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FAQs

We understand GxP compliance can be complex, so we’ve gathered answers to some of the most common questions to help you navigate the process and better understand the requirements.

GxP validation ensures that software and processes in regulated industries, like pharmaceuticals, meet specific guidelines for quality and safety. Compliance means adhering to these GxP standards throughout the software development lifecycle.

GxP validation is crucial because it ensures that the products and processes used in life sciences are safe, effective, and meet regulatory standards. Compliance reduces risks of failures, delays, and potential legal issues during regulatory submissions.

GxP in software development refers to ensuring that the software used in regulated industries meets Good Practices (GxP) guidelines. GSEP (GxP Software Engineering Practices) ensures that the software is reliable, traceable, and compliant.

The best technologies for GxP validation include R, Python, Git for version control, automated testing tools, and cloud platforms like AWS or Azure. These tools ensure proper documentation, traceability, and regulatory compliance in software development

The FDA submission process involves preparing detailed documentation of the product’s development, testing, and validation. It includes reports on compliance with GxP standards and evidence that the product meets safety and efficacy requirements.

The EMA submission process requires thorough documentation on clinical trial data, validation of processes, and adherence to GxP standards. The submission focuses on proving that the product is safe and effective for market approval within the EU.

Let's validate GxP Together

Ready to Tackle Your GxP Challenges?

We’re here to help! Share your project with us, and let’s discuss how we can streamline your GxP compliance needs.

Talk to our Experts