SeltaSquare

The AI+ Certification is an AI quality certification program co-developed by the Korea Standards Association (KSA) and Wisestone, which rigorously evaluates the quality of products and services incorporating AI technology based on standards set by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

In this certification process, SELTA-WAVE underwent comprehensive verification of quality and ethical accountability across its full lifecycle — from product development through to service delivery — in accordance with ISO/IEC 25059:2023 (Quality Model for AI Systems) and ISO/IEC 25023:2016 (Systems and Software Quality Measurement).

SELTA-WAVE successfully passed the international standard quality assessment, with a particular focus on evaluating the suitability of its AI functions. It completed objective testing across key quality attributes — including accuracy, reliability, usability, and performance efficiency — and received an official test report, formally demonstrating the product's excellence.

SELTA-WAVE is an AI-based Safety Data Solution that provides advanced capabilities across the full pharmacovigilance lifecycle, including automated ICSR (Individual Case Safety Report) processing, regulatory authority report generation, data quality inspection, and error detection. Through this AI+ Certification, SELTA-WAVE has been recognized as a solution that not only meets international quality standards but also guarantees stability and consistency in real-world commercial environments.

As AI technology rapidly expands its influence across industries, ensuring quality and ethical integrity from the earliest stages of development has become essential. Comprehensive quality management — extending beyond mere functional implementation to encompass data bias, model reliability, operational stability, and ethical accountability — is increasingly regarded as a critical factor in building user trust and driving the positive advancement of AI technology. Systematic quality verification processes such as the AI+ Certification contribute to the creation of a safe and trustworthy AI ecosystem by identifying and managing potential risks throughout design, data collection and management, model development, and service operations.

Through this certification, SeltaSquare is now positioned to deliver tangible value to customers in the pharmaceutical and bio industries, including enhanced reliability and accuracy in pharmacovigilance operations, a more advanced framework for responding to global regulatory requirements, and greater transparency in AI-based data processing.

Sergey Denisov, Head of SeltaSquare's AI Team, stated: "SELTA-WAVE receiving the AI+ Certification means that SeltaSquare's AI technology has met international quality standards. We will continue to deliver innovative pharmacovigilance solutions that conform to global standards."

Demos and consultations for the AI+-certified SELTA-WAVE are available through SeltaSquare's official website.

Read the Original Articles:

• PharmNews: SeltaSquare Obtains International Standard-Based AI+ Certification
• DailyMedi: Pharmacovigilance Solution SELTA-WAVE Achieves 'AI+ Certification'
• Money Today: AI Pharmacovigilance Solution 'SeltaSquare' Obtains International Standard-Based AI+ Certification
• Enet News: SeltaSquare Completes International Standard-Based AI+ Certification