GxP in Software Development
We will ensure high quality of your software, so you can seamlessly go through FDA / EMA submission process.
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.
We guarantee high-quality code and strong security, so your systems run smoothly and meet regulations.
Our ready-to-use tools speed up development, saving you time and keeping your company competitive in the pharma market.
With biotech and software engineering expertise, we address your unique challenges, helping you drive innovation in clinical development.
You can start with an audit or development support, and scale up as your needs grow, giving you full flexibility.
Reducing the time needed to generate Annual Product Quality Review (APQR) by 85% for a premier biopharmaceutical company's GxP compliance process.
Reduction in manual reporting, allowing teams to focus on high-value tasks.
Automation of GxP reports, improving accuracy and 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
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.
With over a decade of experience and world-class engineers, we bridge the gap between software development and successful drug development.
Our team consists of the top 1% of software engineers globally, bringing unmatched expertise in developing GxP-compliant software for biotech and pharma.
We’ve successfully delivered hundreds of projects for top biotech and pharma companies, providing the technical foundation for clinical trials and drug development.
Our proprietary Definitions of Done (DoD) and Appsilon Quality Test (AQT) processes ensure that your software meets the highest standards of GxP compliance.
We combine cutting-edge technology with scientific expertise to deliver high-quality, compliant solutions.
Download a checklist designed for clinical managers in data departments to make sure that software meets requirements for FDA and EMA submissions.
Get the ChecklistSarah Gasman, Senior Data Analyst
Boston Medical Center
Robin Whytock, Research Fellow
University of Stirling
Bill Adams,
Boston Medical Center
Our solutions are designed to meet your GxP compliance needs, ensuring your company stays audit-ready and efficient.
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.
We’re here to help! Share your project with us, and let’s discuss how we can streamline your GxP compliance needs.
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