Leading global pharmaceutical manufacturer relies on Stratus for batch record quality assurance

Business Situation

Millions of people around the world benefit daily from innovative medicines and widely used drug therapies designed to improve their health and way of life. To ensure consistency and quality throughout the drug manufacturing process, global leaders in this industry rely on meticulous record keeping. Every step of every batch in the production process is closely guarded and recorded. Compliance with strict government mandates is imperative but the integrity and reputation of the pharmaceutical maker remains the most important factor for long-term success.

To secure each batch, data must be captured at regular intervals at the MES (manufacturing execution system) level. If manufacturing data is lost or if there are "gaps" in the data due to downtime of the system, the quality chain is broken and the batch must be discarded. A single batch of a blockbuster drug can easily represent production costs and sales value in multiple millions of dollars, making data integrity a well understood factor in this industry.

For most companies, the batch documentation process was a largely manual effort. In response to the 21 CFR Part 11 government mandate, pharmaceuticals began looking to their IT professionals for ways to automate and standardize this process across all of their manufacturing sites. For a global leader with facilities in 17 countries, this meant a continuously available Stratus-based Electronic Batch Record (EBR) solution.

Stratus-based Solution

The company’s IT group selected plant historian software from a well known maker and then evaluated three choices to ensure continuous uptime of their new application: load balancing, high-availability clusters, and Stratus ftServer W Series systems. They quickly ruled out the first two options. The application did not lend itself to load balancing. The cluster implementation required changes to the application and would have been more complicated to support and update across the many local manufacturing sites where the software would run.

Validation was another issue with clusters. The U.S. Food and Drug Administration requires validation of computing hardware and software that perform electronic batch record keeping before being placed into operation. The process means considerable time and money on the part of the pharmaceutical company.

Simplicity of design, deployment, and operation -- coupled with exceptional proven reliability -- were the deciding advantages in favor of the Stratus' fault-tolerant Windows solution.

Business Impact

The solution captures real-time information from SCADA nodes at the plant level and sends it to a separate electronic batch record (EBR) system that creates a complete trail of the manufacturing process. Two ftServer systems are installed at each manufacturing site. One server is used in production. It is connected by high-speed fiber to the other server located in a bunker site, providing backup in case of an outage to the production computer room.

A technology architect for the pharmaceutical company gives high praise to the new solution, “You set up the Stratus ftServer system, it runs, and then you forget about it. It just doesn’t break,” He adds, “After a system linked to batch record keeping is put in place and validated, that system becomes part of our quality assurance procedures.” To-date this highly successful solution has been replicated at 20 of the company's manufacturing sites.

The single system design of the server makes it as easy to install and maintain as an ordinary stand-alone system. But, its proven real-world uptime, which surpasses 99.999%, is anything but ordinary. Taking advantage of Stratus' continuous availability features is far less complex than other high-availability alternatives; you simply load your application. No application changes, special programming or scripts are necessary to achieve the highest levels of availability offered in the industry. Self-monitoring and online ActiveService capabilities, built into every Stratus system, detect, isolate, report and resolve problems before they cause system downtime.

The emergence of electronic batch record keeping reflects the pharmaceutical industry’s increasingly wider use of IT to support manufacturing processes. There is a greater need for information access and visibility associated with manufacturing facilities. The days of a plant being able to function with isolated systems that didn’t connect well to the larger enterprise are gone.