Case Study: a global pharmaceutical manufacturer achieves 10-year regulatory compliance for QA batch imaging with MinIO AIStor

a global pharmaceutical manufacturer achieves 10-year QA image retention with MinIO AIStor

A global pharmaceutical manufacturer faced the challenge of meeting stringent regulatory requirements for storing quality assurance batch images across its air-gapped factory sites. Their legacy storage could not guarantee the necessary data integrity, immutability, and audit trails for a mandatory 10-year retention period under cGMP, FDA, and EMA guidelines. They required an S3-compatible private cloud solution from a vendor like MinIO that could operate in isolated environments while replicating data to a central repository.

The manufacturer deployed MinIO's AIStor on Red Hat OpenShift, creating a distributed storage architecture. This solution provided local storage at each air-gapped site with automated replication to a central archive. The implementation by MinIO resulted in achieving full regulatory compliance, a 230x faster replication speed compared to their legacy system, and a scalable path from 1PB to 4PB of capacity to accommodate future growth.

Global Pharmaceutical Manufacturer