EBR now part of suite

New EBR capability enables users to address exceptions and process deviations in real-time, reducing wasted time, money and materials

Rockwell Automation has released its FactoryTalk Pharma Suite 2.1 software. FactoryTalk Pharma Suite applications now incorporate electronic batch recording (EBR) capabilities, and are tailored to the needs of pharmaceutical and biotech manufacturers. The new release continues the tradition of innovations that set Pharma Suite apart, and extends its capabilities in supporting a true “review-by-exception” methodology.

With Pharma Suite 2.1 exceptions during batch recording can be reviewed and addressed in real-time, not after the fact, as is typical for paper-based or “paper-on-glass” workflows. The exception handling during the EBR execution occurs during the manufacturing process, allowing the operator on the shop floor to address exceptions as the manufacturing rules are enforced in real-time. This reduces wasted time, money and materials. New usability capabilities also allow quality personnel to start investigating process deviations as they occur on the shop floor, rather than wait for batch completion. Collected exceptions are the starting point for the batch review process. The online batch record review capability allows quality control personnel to more efficiently judge the documented deviations and to close out the review process more quickly and with fewer process deviations.

The new EBR capability reduces the amount of time spent on batch review after completion of the batch, which means the finished products spend less time warehoused waiting for the release. This reduces inventory costs, increases turnover and allows the product to spend more time in the distribution channel before its shelf life expires.
All quality-related processing information is compiled in a holistic batch record based on the ISA S88 standard. Pharma Suite also provides the capability to render batch record information in different publishing formats like PDFs, HTML, XML and classic paper-based reports.

Rockwell Automation recently presented these new capabilities at its 11th Annual International Life Sciences Symposium in Montpellier (F June 2010). The event brought together senior managers from the world’s top 50 pharmaceutical companies and gave them an opportunity to network, share best practices and learn more about the latest industry trends. Attendees applauded the new capabilities including the use of role-based views and reports, the ease of system usability, the adaptation of industry standards and the ease of deployment.

“Pharma Suite 2.1 is the next logical step to break the old ‘paper-on-glass’ paradigm,” said Martin Dittmer, FactoryTalk Pharma Suite product manager, Rockwell Automation. “For years, EBR has been interpreted as putting the old paper system behind computer screens; however, computer-based systems are capable of much more. Pharma Suite continues to incorporate new and exciting capabilities to assist our customers in accelerating their innovation and shortening time to market. Pharma Suite is optimized to help users maximize their productivity at each step of the recipe lifecycle from recipe design to execution, review and approval.”

In Pharma Suite, recipes are modeled graphically and aligned with the ISA S88 standard. Visual tools and intelligent search mechanisms help ensure that all information required for recipe design can be accessed quickly and easily. Recipes are assembled from reusable parameterized building blocks that represent standard functions such as adding material to a process or checking equipment against requirements. Pharma Suite also allows the reuse of pre-configured building blocks to accelerate recipe design, reduce errors and speed validation, resulting in faster deployment.

The recipe execution client of Pharma Suite maximizes operator efficiency by focusing on the operator’s main workflow. The system guides the operator through complex processes and helps ensure that all tasks are completed according to the recipe. Deviations are handled by the built-in exception management that delivers important input for review by exception.

Pharma Suite is based on the state-of-the-art FactoryTalk ProductionCentre manufacturing operations platform, which is proven in hundreds of installations across different industries and scales of deployments. It leverages a service-oriented architecture for cost-effective, flexible deployment, as well as integration with business and automation systems. Its object-oriented design makes it easier and faster to build, modify and systematically deploy applications across multiple sites.