Oracle adds pharma PLM for drug development & production

22-Sep-2010 - Last updated on 23-Sep-2010 at 10:34 GMT

Oracle is revising its lifecycle management package to streamline processes including scale-up to commercial production and QbD implementation.

By tailoring a Product Lifecycle Management (PLM) package to pharmaceutical manufacturers Oracle believes it can help these clients “dramatically reduce costs”, simplify business networks and shorten time to market.

Oracle’s Agile PLM 9.31 focuses on seven areas of the pharmaceutical lifecycle to achieve these improvements. For instance, the package simplifies analysis of suppliers, materials, equipment and processes to support biopharm efforts to scale-up commercial production volumes.

Earlier in development PLM can be used to manage material allocations, equipment reservations and recipe variations during clinical trials. Using PLM for these tasks shortens clinical trial timelines, according to Oracle.

“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”, said Neil de Crescenzo, general manager, health sciences global business unit at Oracle.

PLM also includes a quality management system which allows guidelines and quality-by-design (QbD) to be built into product development from the start. Integrating these elements allows for faster and more efficient submissions, according to Oracle.

Integrated packaging and label management is also achievable using PLM. The package uses a global repository of all packaging components, digital assets and marketing collateral to improve the regulatory integrity of commercial content.

Earlier and later stages

PLM includes features to support drug development. For instance, the package can be used for drug development portfolio management. Oracle says this can improve drug development execution, programme management and cross function collaboration.

Structured drug development records can also be maintained using PLM. These records capture multi-dimensional data from material, equipment, processes and analytical methods to enable re-use of common technical documents.

Later in development PLM can be used for global product registration. In this instance PLM supports re-use of registration content to improve return on investment for each new product.