Appsilon GxP Audit
A comprehensive diagnosis of your R and Python software and computing environment compliance with actionable recommendations and areas for improvement.
Software validation is an important element of success in submitting to regulatory bodies. We will help you improve development workflows, implement secure software practices, conduct unit and performance tests, and ensure proper documentation.
Avoid wasting billions due to failed submissions caused by non-compliance.
Prevent delays by meeting regulatory requirements from the start.
Cut time spent on manual reporting tasks in half, enabling teams to focus on high-value work based on demonstrated results.
Reduce expenses over three years through automated compliance and operational efficiency driven by proven methods.
Eliminate manual errors and enhance data accuracy throughout your processes with results rooted in practical experience.
Get a detailed evaluation of workflows and compliance gaps, with actionable recommendations delivered to meet GxP standards.
Book The AuditCovering good development, security, validation, and reproducibility
Delivering results efficiently within a streamlined process.
Highlighting risks, compliance gaps, and key areas for improvement
Providing step-by-step guidance to achieve GxP compliance.
Targeted support to equip your staff with knowledge to implement best practices effectively.
Appsilon empowers pharmaceutical and life sciences companies to leverage open-source technology for faster, data-driven decision-making in regulated environments.
Only 1% of applicants pass our rigorous selection process, ensuring top-tier engineers.
Our packages are actively shaping the ecosystem with significant contributions from our engineers.
With 5 PhDs on the team, we share insights through conferences and published research.
The majority of our applications are integrated into key business operations, driving success for our clients.
Director, at Top 5 Pharma Company
Basel, Switzerland
Director
at Top10 Pharma Company
Director, at Top 5 Pharma Company
Basel, Switzerland
See how clients improved compliance, simplified workflows, and worked more effectively with our solutions.
Find clear answers to common questions about GxP compliance, helping you navigate regulations with confidence.
Appsilon provides ongoing support to ensure the successful implementation of audit findings. Our services include implementing recommendations from the audit, building Statistical Computing Environments (SCE), developing dashboards, and leveraging AI to support drug discovery and compliance efforts. Whatever your needs are, we are here to assist with tailored solutions.
Yes, our team is available to assist with implementing recommendations and optimizing your processes as needed.
Our services help with FDA/EMA submissions by setting up GxP-compliant environments, preparing documentation for audits and ensuring data accuracy through testing to improve development processes.
We also offer services such as GxP best practices, performing risk assessments, validating custom software tools, and providing ongoing support to maintain compliance. We can also help with dashboards, platform management, Statistical Computing Environments (SCE), DataOps, cloud infrastructure, and using AI to improve processes.
Our audit team includes senior-level architects to review code and workflows, platform engineers to evaluate infrastructure, and project managers to compile comprehensive reports based on industry standards.
We can begin working together 4 weeks after signing the agreement. This allows us time to prepare a team and ensure a smooth onboarding process into your systems.
We’re here to help! Share your project with us, and let’s discuss how we can make sure your software meets regulatory requirements.