GxP in Software Engineering
GxP Validation and Compliance for Pharma
We will ensure high quality of your software, so you can seamlessly go through FDA / EMA submission process.
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.
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.
Guiding You Through GxP Compliance
We help companies navigate the complexities of GxP compliance, ensuring fast adoption of technology and meeting regulations efficiently.
Sarah Gasman - Senior Data Analyst
Boston Medical Center
GxP Compliance Audit
Conduct a comprehensive analysis of your software compliance and receive a detailed report with actionable recommendations and areas for improvement.
Shiny Dashboards in R and Python
Develop GxP-compliant dashboards that provide real-time insights, ensuring accurate data visualization and compliance support.
Data Platform & Cloud Solutions
Build validated environments for cloud, operations, data management, ML, AI, and engineering, ensuring compliance and reproducibility.
Statistical Computing Environment
Enhance, automate, and ensure the rigor of statistical analysis, enabling the development and execution of statistical programs within a unified system.
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.
Leveraging the Best Technologies
We combine cutting-edge technology with scientific expertise to deliver high-quality, compliant solutions.
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 ChecklistHelping Pharma Teams Like Yours Achieve GxP Compliance
Sarah Gasman, Senior Data Analyst
Boston Medical Center
Robin Whytock, Research Fellow
University of Stirling
Bill Adams,
Boston Medical Center
Driving GxP Compliance for Leading Pharmaceutical Companies
Our solutions are designed to meet your GxP compliance needs, ensuring your company stays audit-ready and efficient.
Get Custom GxP Compliance Guidance
Stay Informed with GxP Compliance Tips and Trends
How Good Automated Testing Supports GxP Compliance in Software Development
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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.
What is GxP Validation and Compliance?
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.
Why is GxP Validation Important?
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.
What is GxP in Software Development (GSEP)?
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.
What are the Best Technologies for GxP Validation?
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
What Does the FDA Submission Process Look Like?
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.
What Does the EMA Submission Process Look Like?
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.
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Ready to Tackle Challenges with GxP?
We’re here to help! Share your project with us, and let’s discuss how we can make sure your software meets regulatory requirements.