Validation services for AI GVP (GxP) implementation considerations.

To pharmaceutical and medical device manufacturers planning the introduction or update of an AI-enabled GVP (GxP) compliant system!

The "AI GVP (GxP) Implementation Consideration (and Post-Implementation) Validation Service" is a service that supports GVP/CSV reliability assurance and validation when conducting a "Feasibility Study: Evaluation of Implementation Viability" for a PV System with AI functionality. In the era of AI utilization, pharmaceutical and medical device manufacturers face regulatory and compliance challenges in ensuring the safety of patients and health examiners. To address these challenges, our company provides PV consulting services for PV Systems equipped with AI functionality, offering services during implementation evaluation and operational phases (before and after implementation). 【Provided PV Services (partial)】 ■ GxP CSV compliance for SAP ERP System (S4/HANA, Solution Manager, MDG) ■ Proposals for improving safety adverse event case data input, evaluation, and regulatory reporting ■ Provision of safety regulatory information from regulatory authorities in Japan, the United States, Europe, and Asia ■ Training sessions on ICH E2B (R2)/(R3) guidelines *For more details, please download the PDF or feel free to contact us.

others