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専門性、コンプライアンス、規制準拠

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。

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

Overview of GxP package and optional support services
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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.