Leading global pharmaceutical manufacturer relies on Stratus for electronic batch record (EBR) quality assurance

To automate and standardize batch data record collection across facilities in 17 countries, a leading pharmaceutical manufacturer selected plant historian software running on ftServer W Series systems. These Stratus systems are built from the ground up to provide the continuous uptime required for 21 CFR part 11-compliance; but that's not the only reason they were selected. Simplicity of deployment and operation coupled with exceptional availability technology were the deciding advantages offered by Stratus.

The FDA requires validation of all hardware and software that perform electronic batch record (EBR) keeping in these highly regulated pharmaceutical environments. Stratus' single system design proved much easier to validate than multiple-system clusters. And, once validated, the Stratus systems were far easier to deploy and maintain across a large manufacturing enterprise.

Now in operation at more than 20 sites worldwide, the new solution captures real-time information from plant SCADA nodes and sends it to a separate EBR system, creating a complete automated trail of the manufacturing process. Stratus systems are being used as the production server and for offsite backup/disaster recovery. The new solution provides round-the-clock quality assurance and protection of batches that can represent multiple millions of dollars in manufacturing costs and sales value.

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