Expertise. Compliance. Regulatory Excellence.
Choose a validation-ready software solution for your drug development and manufacturing operations while safeguarding data integrity, privacy, and security to meet FDA, EMA, and other regulatory expectations. Navigate the road to compliance with an experienced partner who understands data governance challenges and digital best practices. Partner with Genedata.
GxP Validation. Made Easy.
Easily deploy Genedata solutions in a regulated environment with our GxP license and validation support. Whether you choose to handle validation yourself, collaborate with Genedata experts, or take advantage of our managed IT services for added operational support, our GxP support offering is tailored to meet the specific needs of each project. Find out more about the three different validation packages and contact our experts to discuss the best option for you.
Our Customers
We needed a central platform to capture and process data across our global R&D teams, while ensuring full data integrity and traceability, and Genedata was the only solution that ticked all the boxes right from the start.
The Genedata [...] platform is used productively in a validated environment and is helping to democratize access to integrated data in the translational research and clinical settings.
...we want to trust the data and the data is really the most important that that company has. And I think Genedata really gave us this peace of mind in terms of data traceability and even FAIRness.
Road to Compliance. Together.
In view of strict regulatory requirements and constantly evolving risk- and technology-based strategies in validation, the path to compliance requires close cooperation between software suppliers and pharmaceutical companies to identify and support specific business processes. Genedata offers a tailored approach to ensure smooth alignment with quality and compliance requirements.
We support your validation projects with comprehensive documentation, full traceability from requirements to test, and professional training. Our experts support your risk assessment and validation activities in an agile, collaborative approach according to your method and procedure in place.
View our Genedata Quality Policy for more details.
