Rockwell Automation introduces electronic batch recording to FactoryTalk Pharma Suite.
Rockwell Automation has extended its set of software applications tailored for pharmaceutical and biotech manufacturers, FactoryTalk Pharma Suite, to include electronic batch recording (EBR). The new release comes with a graphical recipe workbench and an enhanced recipe execution client. Both are optimised to meet the needs of target users and provide excellent usability, look and feel.
“Innovation and time to market are the main drivers in the pharmaceutical industry today, and we designed FactoryTalk Pharma Suite to support exactly that. We broke with the old ‘paper-on-glass’ paradigm and optimised FactoryTalk Pharma Suite for maximum productivity of every user at every step of recipe lifecycle, from recipe design to execution, review and approval. This product extends our traditional strength in large-scale pharma-manufacturing to biotech and is well aligned with the latest industry direction – personalised medicine,” explains Vladimir Preysman, chief strategist, Rockwell Software.
In FactoryTalk Pharma Suite, recipes are modelled graphically and aligned with the S88 standard. Visual tools and intelligent search mechanisms help ensure that information required for recipe design such as material, equipment, recipe building blocks, or process parameters can be accessed quickly and easily.
Recipes are assembled from re-usable, parameterised building blocks that represent standard functions like adding material to a process or checking equipment against requirements. The software also allows recipe authors to isolate and save sections of a recipe as custom building blocks. After focused tests and reviews, these building blocks can be reused in new recipes. This accelerates recipe design, prevents errors and enables incremental validation resulting in faster deployment.
“Pharma Suite has proved to be a flexible and agile MES platform that can be deployed in a short time,” says Robert Fretz, head of process automation and MES at Roche. “Its built-in application development framework enables our engineers to install, configure and extend the system by themselves, which was one of the major decision criteria when we were evaluating a material tracking and weighing system for our production.
“The recipe building blocks capture a wealth of domain knowledge and best practices from many successful EBR projects delivered by Rockwell to pharmaceutical and biotech customers worldwide,” says Preysman. “Now, we are expanding this to provide an open and extensible system. We offer IT departments and system integrators the tools to develop their own recipe building blocks in order to address their customers’ individual needs.”
The recipe execution client maximises efficiency by focusing on the operator’s workflow. It has been designed for interaction via a touch-screen and 2D barcode scanner, and provides excellent usability and ergonomics supporting efficient operator performance and compliance with GxP. The system guides the operator through complex processes and helps ensure that all tasks are completed according to the recipe. Deviations are handled by built-in exception management that delivers important input for review by exception.
FactoryTalk Pharma Suite is based on the state-of-the-art FactoryTalk ProductionCentre platform. It leverages a service-oriented architecture (SOA) for cost-effective, flexible deployment and integration with business and automation systems. Object oriented design makes it easier and faster to build, modify, and deploy applications across multiple sites.
For more information contact Jeff Sandison, Rockwell Automation, +27 (0)11 654 9700, [email protected], www.rockwellautomation.co.za
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