Oracle has announced Oracle’s Agile Product Lifecycle Management (PLM) 9.3.1 to help pharmaceutical companies streamline drug development processes, reduce waste, leverage global networks and enable Quality by Design (QbD) practices.

The latest release also includes new cross industry capabilities that support the entire product value chain. For example, Agile PLM 9.3.1 provides deeper product lifecycle analytics, next generation multi-CAD integrations, complex technical documents management, design variant management and many other usability and functional enhancements.

Oracle’s Product Value Chain solution includes Oracle’s Agile PLM, Oracle Product Hub, Oracle’s AutoVue Enterprise Visualization and Oracle Product Data Quality. Relying on these offerings, customers can manage all product information, integrate product lifecycle processes and benefit from secure collaboration, data quality and knowledge management.

Streamlining and Enhancing Product Value Chain Processes

The existing and new Agile Enterprise PLM capabilities for pharmaceutical organizations include:

Drug development portfolio management: Enables critical program deliverables and regulatory requirements to be enforced by improving drug development execution, program management and cross function collaboration.

Comprehensive drug development records: Structured drug development records facilitate re-use of Common Technical Documents (CTD) by capturing complex multi-dimensional data from material, equipment, process/recipes and analytical methods in one system.

Efficient clinical supply management: Delivers faster clinical trials by allowing material allocations, equipment reservations and recipe variations during the clinical trials phase to be efficiently and effectively managed.

Faster technology transfer: Facilitates the scale-up to commercial drug production volumes by enabling the drug product value chain, including suppliers, materials, equipment and processes, to be analyzed.

Integrated quality and risk management: Delivers an effective enterprise quality management solution that enables new guidelines and QbD practices to be built into the beginning of product development for faster and more efficient submissions.

Integrated packaging and label management: Improves the regulatory integrity of commercial content by providing a global repository for all packaging components, digital assets and marketing collateral that references development evidence.

Global product registration: Provides the content needed to support regulatory submittal requirements. This content is used for on-going global product proliferation. Re-use of registration content can significantly improve ROI for each new product developed.

To support customers in the hi-tech, industrial, consumer packaged goods, retail and life science industries, the latest release also includes:

New Enhancements in Agile Product Lifecycle Analytics: Enables users to prioritize and monitor project progress and costs, mitigate risks and drive continuous improvement by providing actionable insights into product pipelines, project schedules and phase gate processes.

Agile Next Generation CAD Connectors: Provide rich design data management and collaboration capabilities including managed workspaces, external references and interchange assemblies across today's multi-disciplinary mechatronic engineering environments.

Agile Design Variant Management: Manages the model/option and instance byte order mark (BOM) integration with Oracle Product Hub and Oracle Configurator to provide an end-to-end mass customization environment.

Additionally, Agile PLM 9.3.1 supports dynamic publishing of complex product documents, while also introducing core improvements in personalization, workflow, IP management and security, schedule and resource management, configurable price management and sourcing response analysis and selection.

Supporting Quotes

“Pharmaceutical manufacturers operate in a highly regulated environment that has some of the most complicated value chains and business processes,” said Eric Newmark, research manager, IDC Health Insights. “These companies require solutions like Oracle’s Agile PLM which helps address the shifting landscape they face by streamlining complex processes, reducing waste, improving collaboration and supporting compliance with incredibly strict regulations.”

“We are committed to helping organizations across all industries manage product value chain processes so that they can accelerate product innovation and maximize product profitability,” said Hardeep Gulati, Oracle vice president PLM and PIM Product Strategy. “With this release, Oracle has added new differentiated capabilities that enable pharmaceutical drug development while also enhancing the deep cross industry capabilities delivered in Agile Enterprise PLM.”

“Agile PLM 9.3.1 is highly complementary to our other significant investments and capabilities within Life Sciences,” said Neil de Crescenzo, Oracle senior vice president and general manager, Health Sciences Global Business Unit. “With the new Agile PLM capabilities and our recent acquisition of Phase Forward we have a comprehensive solution for clinical trials and clinical supply management.”