JustSystems reveals recipe for pharma transformation

JustSystems, the largest independent software vendor in Japan and a worldwide leader in XML and information management technologies, has developed 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" dynamic document initiative to ensure that companies share accurate, consistent, and complete information across the multiple steps of the drug discovery and development process.

"Today, pharma and biotech companies use spreadsheets and other static documents to create and maintain their process definitions which are effectively the 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. 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."

In addition, pharmaceutical companies face another challenge in their spreadsheet-based processes: getting all the recipe information into the MES and batch control systems. Typically, recipe information must be manually re-entered into these systems, a time consuming and error prone process.

The JustSystems solution enables life sciences companies to standardise information transfer between research, manufacturing operations, regulatory affairs, and suppliers; reduce waste from failed batches; and comply with regulatory submissions. The system supports Quality by Design (QbD) and claims to be 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.

This file format enables recipes to be read by other applications that support BatchML, such as MES, Product Lifecycle Management (PLM), batch control, and compliance solutions.