MES: The Right Medicine for Drugmakers: Page 3 of 3

MES: The Right Medicine for Drugmakers

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time. Currently, reviewers must pore over hundreds of pages of documents before they release a shipment. This task often takes a month, delaying time until revenue, while shortening shelf lifetimes and creating headaches for shipment schedulers. Going to electronic systems can streamline this part of the cycle. “Electronic batch recording (EBR) can reduce that idle time from weeks to days,” Reitter says.

That time savings is possible because EBR and MES provide enough confidence in the processes that examiners can look at alarms and other event recordings to see how they impact quality, rather than examining every piece of paper to assure quality.

One aspect of this is to maintain the signoffs commonly used in today’s paper trails. “When operators start a mixer or change the amount of a chemical, they have to enter their password to confirm that they did the job, creating an electronic signature that’s logged into the audit trail,” Reitter says. Going beyond that, many companies are looking at ways to tie MES, ERP and other systems together, automating processes instead of simply digitizing the data, he adds.

Having this information in a searchable digital format will help companies respond when they’re audited or when problems arise. “Manufacturers who put their data into MES can take it forward with full traceability,” says Tom Comstock, vice president of product marketing at Brooks Software.

While integrating MES is today a big issue, observers note that at some point, the technology will become part of the landscape. Programs will merge into enterprise-wide programs. “Users won’t know they’ve just finished a page in MES and gone to a lab information system, the applications will start blending together,” Sterrett says.

For more information, search keyword “MES” at www.automationworld.com.

See sidebar to this article: Cleaning Up Integration

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