医薬品の開発・製造で使用されるソフトウェアソリューションには、FDA・EMA・PMDAなどの規制当局の定める要件に準拠したデータインテグリティー・プライバシー・セキュリティーの保証が求められます。そのため、企業が新たなプロセスのコンプライアンス対応を進めるには、データガバナンスの落とし穴とデジタルのベストプラクティスを理解しているパートナーが必要です。
このような課題には、Genedataソリューションが最適です。
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 Profiler 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
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 engage a partner, our validation 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.
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 in order to identify and support specific business processes. Genedata offers a tailored approach to ensure smooth alignment with quality and compliance requirements.
Our in-house experts have extensive experience in developing, deploying, and managing biopharma systems in regulated environments and our quality management system (QMS), processes and procedures are designed to optimally support your validation projects. Comprehensive documentation, full traceability from requirements to test, and professional training are provided and 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.