How Logilab SDMS helped a COVID vaccine manufacturer achieve Data Integrity, Compliance & Automation

How Logilab SDMS helped a COVID vaccine manufacturer achieve Data Integrity, Compliance & Automation

A leading biopharmaceutical organization and early innovator in COVID-19 vaccine development required a computerized system to ensure data integrity, regulatory compliance, and automation across its manufacturing QC and research laboratories. With growing GMP expectations and complex cloud infrastructure requirements, the organization needed a secure, scalable solution capable of centralizing instrument data, enforcing 21 CFR Part 11 compliance, and integrating seamlessly with CDS and LIMS systems. This case study outlines how Logilab SDMS with the CFR Gateway addressed these critical needs.

Inside this case study, you’ll learn:

• How automated instrument data capture created a centralized and reliable source of truth
• How CFR Gateway enables 21 CFR Part 11 compliance within GxP environments
• How metadata tagging and structured archiving improved traceability and long-term data management
• How cloud deployment supports scalable, compliant laboratory operations