JustSystems, Inc., the largest independent software vendor in Japan and a worldwide leader in XML and information management technologies, has announced a first-of-its-kind batch manufacturing process definition solution for life sciences companies.
Developed with one of the world's largest management and technology consulting firms, the new solution builds on JustSystems' recently announced dynamic document initiative to ensure that companies share accurate, consistent, and complete information across the multiple steps of the drug discovery and development process. (See see related announcement: "JustSystems Champions ‛The Document as the Application.'"
"Today, pharma and biotech companies use spreadsheets and other static documents to create and maintain their process definitions—which are effectively product recipes—and transfer them from R&D to manufacturing operations," said Paul Wlodarczyk, vice president of solutions consulting for JustSystems. "A key challenge is ensuring the information in these documents is accurate and authoritative as the product moves through its lifecycle and across the supply chain," he said.
"Another challenge is identifying, tracking, and reporting on the critical-to-quality process parameters. Our solution for batch process definition is ideally suited to address all these demands," Wlodarczyk said.
In addition to keeping information accurate, pharmaceutical companies face another challenge in their spreadsheet-based processes: Getting all the recipe information into the manufacturing execution systems (MES) and batch control systems that drive operations on the plant floor. Typically, recipe information must be manually re-entered into these systems, a time consuming and error prone process.
To improve operations for pharmaceutical and biotech companies, the JustSystems process definition solution builds on the company's unique dynamic document vision. Document applications blur the lines between traditional documents, that provide rich context, persistence, and portability, and business applications, that provide live data and an interactive user experience. The result is a dynamic document that comes to life, providing users a rich new context for diverse and distributed information sources that are always up to date.
Inside Recipe and Process Management
The JustSystems solution enables life sciences companies to standardize information transfer between research, manufacturing operations, regulatory affairs, and suppliers, the company says. It helps reduce waste from failed batches and to comply with regulatory submissions. This breakthrough system supports quality by design (QbD). It is also the only solution of its kind that supports both the ANSI/ISA-S88 industry standard for batch process definition and BatchML, the XML standard for representing S88 data.
xfy Application Framework
xfy (pronounced "x-fie") is a powerful document-based composite application framework that allows organizations to rapidly unify content and data in a single dynamic document. With no technical knowledge, business users can rapidly assemble rich document-based applications that bring together isolated content and data from disparate sources. xfy dynamic documents are, in essence, applications.
Based on xfy from JustSystems, the solution offers an intuitive graphical user interface that complies with S88 charting standards, so it will be familiar to process engineers. For researchers, it represents a dramatic usability improvement over spreadsheets. xfy for Batch Process Definition enables users to rapidly assemble recipes by dragging-and-dropping recipe "building blocks." Using recipe building blocks life sciences companies can normalize recipes on a common set of reusable manufacturing actions. This dramatically accelerates the process of creating new recipes and standardizes the representation of a firm's manufacturing process intellectual property.
The solution can save recipes as BatchML, an XML file format that enables recipes to be read by other applications that support BatchML. These would include MES, Product Lifecycle Management (PLM), batch control, and compliance solutions.
Says Wlodarczyk: "The xfy for Batch Process Definition solution is a testament to our unique ability to enable business users to create and manipulate industry-standard XML through a rich, intuitive visual interface—without any special training and without ever seeing an angle bracket."
The xfy for Batch Process Definition solution will be featured in a Webcast Feb. 7 titled: "Transforming Technology Transfer and Recipe Management: From Spreadsheets to Standardized Practices." The Webcast begins at 2:00 p.m. eastern time (11:00 am Pacific time) and features representatives from JustSystems, BearingPoint, and AMR Research. To register, visit http://www.pharmtech.com/recipemanagement.
JustSystems also will be participating in several pharmaceutical-related events during the first quarter, including:
· March 3, Woodbury, N.J.: ZapThink's "Practical SOA for Pharmaceutical and Health Care Industries."
· March 24-27, Philadelphia—WBF 2008 North American Conference.
· March 26-28, Philadelphia: INTERPHEX2008
A white paper titled, "Transforming Technology Transfer and Process Definition Management: From Spreadsheets to Standardized Practices" is available at http://gw.vtrenz.net/?SCIGF87K78.
For more information on JustSystems, visit http://na.justsystems.com/.
JustSystems is a leading global software provider with a 27-year history of successful innovation in office productivity, information management, and consumer and enterprise software. With over 2,500 customers worldwide, and annual revenues over $110M, the company is continuing a global expansion strategy that includes the launch of its new enterprise software offering called xfy (pronounced "x-fie"), and XMetaL content lifecycle solutions. JustSystems has worldwide office locations including global headquarters in Tokyo, and regional offices in New York, Palo Alto, Vancouver, and London. The company currently employs over 1,000 people. Major strategic partnerships include IBM, Oracle, and EMC. For more information, visit http://na.justsystems.com/.