AUSTAR Provides Computerized System Validation (CSV) Consulting Services for an Innovative Vaccine Company

Computerized systems are now indispensable in modern pharmaceuticals, driving efficiency across R&D, production, quality control, and supply chain management. By enhancing automation and precision, these systems ensure data integrity and reliability—critical for meeting stringent regulatory requirements. Through rigorous computerized system validation (CSV), pharmaceutical manufacturers maintain GMP compliance throughout the system lifecycle, safeguarding product quality and patient safety.

Project Background:

As an innovative biopharmaceutical company gaining prominence in China's vaccine sector, the client specializes in the development of infectious disease and oncology vaccines, therapeutic drugs, biotech R&D, and the translation of core research achievements. On the production front, the company has established a modern vaccine manufacturing facility equipped with advanced production technologies and a rigorous quality management system to ensure high-quality vaccine production. The facility complies with international standards and boasts robust production capacity to meet market demands. Additionally, the company is actively expanding its global presence, collaborating with research institutions and enterprises across multiple countries and regions to continuously enhance its technological capabilities and market competitiveness.

AUSTAR Solution:

• Computerized System Validation (CSV) for Chromatography Data System (CDS) Software

• Computerized System Validation for Equipment & Instruments

• CSV Review for Equipment & Instruments (Simple Systems)

AUSTAR Value & Client Benefits:

• Successfully completed CSV consulting services within the defined scope, meeting both quality and timeline requirements. Addressed gaps in GMP compliance and validation capabilities of equipment/system suppliers by adhering to relevant GMP regulations, ISPE GAMP 5 guidelines, and global data integrity expectations. Provided cost-effective, tailored service models based on system complexity and novelty to ensure optimal compliance solutions.

• Fostered mutual growth through close collaboration, emphasizing knowledge transfer—“teaching to fish rather than giving a fish”—to elevate the client's expertise in computerized systems and data integrity  compliance.