InfoBatch™ Provides DeltaV Batch Historian Support

June 6, 2003 – Informetric Biosystems today announced general availability of the InfoBatchTM Connector for the Emerson Process Automation DeltaV Batch Historian. With the new DeltaV Connector, manufacturers can incorporate recipe data, alarms, operator actions, critical process parameters, and important batch events into InfoBatch Reports.

InfoBatch enables manufacturers to maximize quality and productivity by demonstrating that Good Manufacturing Practice (GMP) is maintained through all phases of batch production. Users can quickly create comprehensive exception and production reports without programming. Reports can document product uniformity, identify process problems, and analyze key performance indicators.

The initial release of InfoBatch targets biotech and pharmaceuticals manufacturers. The industry traditionally relied on tedious and error-prone manual tracking or custom software applications for batch reporting. The cost of developing, maintaining, and constantly re-validating custom solutions has been significant. By combining a fully configurable batch reporting engine with stringent security and version control, InfoBatch eliminates many of the cost, resource and regulatory issues associated with other reporting methods.

The DeltaV Batch Connector is configured through an intuitive query dialog. The user simply specifies the data type (e.g. recipe parameter, process value, alarm, operator action, etc...) and the desired criteria. For example, alarms can be filtered by area, process cell, unit, and severity. When the report is generated, InfoBatch automatically associates the reported data wth the selected batch.

Bob Engel, a principal founder of Informetric, states “we are pleased by the early response to the DeltaV connector. The fact that this new product has been embraced by the leading manufacturers of pharmaceuticals and biotech products is very encouraging. In addition, we are pleased by the cooperation that we have received from Emerson Process Automation. Emerson is sincerely operating in the best interest of their customers by supporting third-party vendors like Informetric. DeltaV is truly an open environment, which explains why virtually every manufacturer we speak with is adopting DeltaV as their automation platform of choice.”

The pharmaceutical industry is now mandated to comply with new FDA Electronic Reporting regulations (21 CFR Part 11) and must purchase or develop software that can document the quality of drug production in a secure and traceable manner. InfoBatch is the first batch report product which complies with these regulations. It integrates user security, full versioning of all report configuration and an audit trail for all report specification changes. InfoBatch reports are a key component of the drug’s manufacturing Batch Record, which is the vital documentation of manufacturing compliance to FDA regulations.

InfoBatch incorporates a unique secure browser-based interface. As a result, manufacturers can utilize existing computers and network infrastructure while at the same time addressing rigorous security issues dictated by the recent FDA regulations. In addition, InfoBatch supports ad hoc reporting, thus enabling engineering and QC personnel to data mine for process exception conditions from historical archives that can span months or years of operation. InfoBatch incorporates support for the leading process historians, and thus complements existing process control and information systems. InfoBatch can combine data from several sources into a single, cohesive batch report. A key attribute of InfoBatch is that report data is retrieved from the source each time a report is generated. As as result, InfoBatch eliminates the expense and complexity associated with replicating data into a redundant batch historian. The result is increased reliability and lower integration, validation, and maintenance costs.

InfoBatch is available immediately. For additional information, contact Informetric at 1-908-918-0111 or visit the Informetric web site at www.informetric.com.

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