Agile Product Lifecycle Management for Life Sciences


Agile Product Lifecycle Management for Life Sciences
Oracle's Agile Product Lifecycle Management helps life sciences companies bring together disparate organizations, information, and systems to deliver products to market faster, at a lower cost than their competitors, while maintaining compliance with regulatory requirements. Agile is a complete product lifecycle management solution suite built on industry best practices that enables organizations to manage-from a single interface-the product compliant dataset throughout its lifecycle, including research and development, prototype development, clinical trials, regulatory submissions, new product introduction, market acceptance, and end-of-life content.

Agile PLM includes functionality for key business processes that enables life sciences companies to do the following:

  • Drive product innovation and introduction with one central solution for collaboration across research networks both internally and externally, and managing all product portfolio aspects such as project and resource management, thereby automating the design control process across the organization
  • Lower inefficiency and compliance exposure with a secure workflow-enabled change management processes for core product record components such as development documents and records, product and process specifications, through regulatory submission information providing a compliant archive to support regulatory audits
  • Support enterprise quality management by providing one central solution for aggregating, analyzing, and acting on product quality issues from customer complaints to manufacturing deviations to adverse-event information or supplier corrective actions, and "closing the loop" on these quality events by resolving the product quality problem and communicating the resolution to all parties involved, including compiling medical device reports for submission to the FDA
  • Enable regulatory compliance by providing the infrastructure to meet the requirements outlined by the FDA's quality system regulations, as well as providing a platform for full compliance with FDA 21 CFR Part 11. Agile also provides solutions to help speed the validation of your Agile PLM system implementation
  • Leverage outsourced research, design, manufacturing, and packaging by providing secure role-based access to product information and progress status, allowing the company to focus on its core competency while ensuring swift progress and high-quality from its networked supply chain