Sunwave Health Implements ARAS PLM System and Conducts Computerized System Validation (CSV) Simultaneously

Recently, Sunwave Health Technology (China) Co., Ltd. (hereinafter referred to as "Sunwave Health") announced the official implementation of the ARAS PLM (Product Lifecycle Management) system and the simultaneous launch of the Computerized System Validation (CSV) project. This initiative marks a solid and crucial step for Sunwave Health in digital transformation and quality compliance management, injecting strong impetus into the high-quality development of the enterprise.

As a world-renowned R&D and manufacturing enterprise of nutritional and health food, Sunwave Health has always been committed to providing high-quality nutritional solutions for global customers through innovative technologies and excellent quality management. With its profound accumulation in the nutritional health field and international perspective, Sunwave Health has obtained a number of international certifications, including ISO 9001, ISO 22000, and FSSC 22000, and has passed quality standard audits by authoritative institutions such as China’s NMPA and the U.S. FDA.

I. ARAS PLM System: Empowering Sunwave Health to Enter a New Era of Digital Management

By introducing the ARAS PLM system this time, Sunwave Health aims to comprehensively optimize the product lifecycle management process through information technology, and improve operational efficiency and decision-making scientificity. The ARAS PLM system will cover core business links of Sunwave Health, such as product R&D, design, production, supply chain, sales, and after-sales service, helping the enterprise achieve data-driven refined management and lay a solid foundation for its sustainable development.

1.1 Data-Driven Decision Support

Through the ARAS PLM system, Sunwave Health can obtain real-time key data throughout the product lifecycle, break down information silos, and realize efficient data flow and sharing. Based on this real-time and accurate data, the enterprise’s management can quickly make scientific decisions, promptly identify and solve potential quality problems and operational risks, thereby improving the overall operational efficiency and market response speed of the enterprise.

1.2 Full-Process Quality Management

The ARAS PLM system provides a comprehensive quality management module, covering functions such as product design review, quality standard formulation, and production process monitoring. From product concept design to finished product delivery, the system strictly controls all links in the product lifecycle to ensure that product quality meets international standards. Through seamless integration with the enterprise’s existing production management systems (such as MES), the ARAS PLM system further strengthens Sunwave Health’s quality management capabilities and provides protection for the enterprise’s high-quality development.

1.3 Supply Chain Collaborative Management

In terms of supply chain management, the ARAS PLM system ensures the efficient operation of the supply chain by optimizing the collaborative operations of raw material procurement, production planning, and logistics distribution. The system can monitor inventory levels in real time and automatically trigger purchase orders, reducing the risk of production downtime caused by raw material shortages. At the same time, through close cooperation and information sharing with suppliers, Sunwave Health can further reduce procurement costs and improve the stability and flexibility of the supply chain.

1.4 Supply Chain Collaborative Management

In terms of supply chain management, the ARAS PLM system ensures the efficient operation of the supply chain by optimizing the collaborative operations of raw material procurement, production planning, and logistics distribution. The system can monitor inventory levels in real time and automatically trigger purchase orders, reducing the risk of production downtime caused by raw material shortages. At the same time, through close cooperation and information sharing with suppliers, Sunwave Health can further reduce procurement costs and improve the stability and flexibility of the supply chain.

II. CSV Validation Services: Laying a Solid Compliance Foundation for Sunwave Health’s Digital Transformation

To ensure the compliance and stability of the ARAS PLM system, Sunwave Health has introduced a professional institution to provide Computerized System Validation (CSV) services. The CSV services strictly comply with international standards such as GMP, FDA, and cGMP to ensure that the system fully meets regulatory requirements during operation and reduces compliance risks.

2.1 Compliance Validation

Through detailed validation plans and rigorous validation processes, the CSV services help Sunwave Health ensure that the functions of the ARAS PLM system are highly aligned with business needs, providing strong support for the enterprise’s international development. The validation process covers links such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring the stability and reliability of the system in practical application.

2.2 Data Integrity and Traceability

CSV validation tools can ensure the integrity, consistency, and traceability of system data. Through strict management of the data lifecycle, Sunwave Health can quickly locate and trace the root causes of product quality problems, providing strong support for the enterprise’s quality improvement and risk management. At the same time, the integrity and traceability of data also provide a strong basis for the enterprise’s compliance audits.

2.3 Risk Control and Continuous Improvement

Based on a risk-control-oriented validation method, the CSV services can help Sunwave Health identify potential risk points and ensure that the system remains compliant after upgrades or changes through continuous validation. This forward-looking risk management model not only improves the enterprise’s operational efficiency but also provides a solid guarantee for the enterprise’s continuous improvement and innovative development.

III. Comprehensive Effects: Digitalization and Compliance Empowering High-Quality Enterprise Development

Through the full-process management of the ARAS PLM system and the compliance guarantee of CSV validation services, Sunwave Health has realized full-chain quality control from product R&D to sales, ensuring the stability and reliability of product quality. The combination of digitalization and compliance not only improves the enterprise’s operational efficiency and market competitiveness but also provides strong momentum for Sunwave Health’s continuous development in the nutritional health field.

A relevant person in charge of Sunwave Health said, "The implementation of the ARAS PLM system and the CSV validation project this time is an important milestone in Sunwave Health’s digital transformation. We believe that through close cooperation with professional institutions, Sunwave Health will achieve significant improvements in digital management, quality compliance, and operational efficiency, and provide higher-quality and safer nutritional solutions for global customers."

In the future, Sunwave Health will continue to deepen digital transformation, explore more information application scenarios, and promote the enterprise’s high-quality development to a higher level.