Digital Innovation Strategy
Syngene International is India’s largest contract research and manufacturing organization, providing its services to a range of global clientele across the pharma, biotech, cosmetics, nutrition, and animal health sectors. From time to time there are regulatory audits, requiring stringent quality data organization. Previously, the company faced challenges like its software being not compliant to regulatory needs, lacking centralized consolidation of data, delay in sample review and reporting time, no online calculations, no audit trails, no harmonized reports, etc.
The company implemented CDS (Chromatography Data Systems), which aims to bring centralization, standardization, scalability, compliance and productivity enhancements. With the implementation of CDS, the company now has the ability to consolidate multi-brand chromatography systems to one single platform. The new system has also eliminated the need to train system operators on multiple vendor software.
With the new system in place, the company has been able to harmonize and consolidate all chromatography system data. Sample review and reporting time has also been reduced by 50 percent. User management controls and audit trails on this platform has ensured data integrity and traceability. This has helped Syngene International in reinforcing client confidence in its systems and processes, strengthening its capabilities to successfully undertake regulatory audits and added to its competitive advantage.