AUSTAR Provided Computerized System Validation (CSV) Consulting Services for a Lighthouse Factory Project of a Listed Company

In the wave of digital manufacturing transformation, Lighthouse Factories have emerged as global benchmarks for smart manufacturing. By deeply integrating cutting-edge technologies like IoT, big data, and AI, they achieve end-to-end intelligent transformation from R&D to production and supply chains, significantly improving efficiency, quality, and flexibility.

As exemplars of innovation, these factories illuminate the path forward for global manufacturing. They solve long-standing challenges—such as low productivity, resource waste, and customization bottlenecks—demonstrating the vast potential of intelligent manufacturing. Their replicable templates accelerate industry-wide digital transformation.

Project Background：

As a leading pharmaceutical company in China, the client specializes in the R&D, production, and sales of innovative drugs, with a strong presence across multiple key therapeutic areas. As a publicly listed company, it holds a significant position in both domestic and international markets, actively expanding global operations through partnerships with multinational pharmaceutical enterprises to enhance its worldwide influence.

In manufacturing, the client has established multiple modern production bases certified by domestic and international regulatory authorities, ensuring product quality meets global standards. Its core products demonstrate competitive advantages across various therapeutic fields, providing patients with diverse treatment options. Additionally, the client embraces digital transformation, collaborating with technology companies to integrate cutting-edge technologies such as big data and AI, optimizing R&D, production, and supply chain management flows to improve operational efficiency and quality control.

AUSTAR Solution：

• Regulatory Compliance Review & Gap Analysis.

• Computerized System Validation (CSV) Audit & Implementation.

• Enhancement of Computerized System Management Procedures.

AUSTAR Value & Client Benefits：

• Successfully delivered the CSV consulting services for the Lighthouse Factory project on schedule and in full compliance with quality standards. All work adhered to ISPE GAMP 5 guidelines and met current regulatory requirements for computerized system validation under US FDA, EU GMP, China GMP, and WHO GMP.

• Focused on capability building, empowering the client’s team through hands-on project collaboration to strengthen their CSV expertise.