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Product
August 26, 2010
ENOVIA’s five Life Sciences Accelerators™ have these common features:
ENOVIA Life Sciences Accelerator for regulatory affairs enables users to organize efficiently the multitude of requirements for submissions to regulatory authorities responsible for medical device safety. The product facilitates communication between Submission team members, within the organization, and with agencies such as the U.S. Food and Drug Administration (FDA). ENOVIA Life Sciences Accelerator for Regulatory Affairs helps companies reduce error and reduce application times through improved submission organization, accountability, and communication.
ENOVIA Life Sciences Accelerator for product quality enables organizations to respond quicker to market opportunities by streamlining product design and submissions to help prevent recurrence in future processes and designs. It provides a holistic quality issue solution by integrating with other related product lifecycle processes to effectively remove the source of problems. It enables organizations to bring industry-leading products to market quicker with more reliability with real time visibility into downstream problems by linking product design data directly to customer complaints and non-conformances.
ENOVIA Life Sciences Accelerator for change control manages modifications to all types of Quality System Regulation (QSR) and International Organisation for Standardization (ISO) regulated documents, procedures and specifications throughout an organisation with previously unattainable levels of automation and control. It provides a single, flexible electronic change control process that enables enterprise-wide collaboration to improve operational efficiency and enforces critical business rules to minimize compliance risk. Using ENOVIA Life Sciences Accelerator for Change Control, companies will attain U.S. Food and Drug Administration (FDA) Part 11-compliant access control, security and traceability as demanded for this mission-critical business process.
ENOVIA Life Sciences Accelerator for product introduction enables project managers from Life Sciences companies to institutionalize best practices while executing new product introduction projects. Project managers are provided with advanced visual project tracking reports to maximize management visibility and control to improve time-to-market and regulatory compliance within product introduction projects while maximizing efficiency and reducing collaboration costs. ENOVIA Life Sciences Accelerator for Product Introduction dramatically increases the productivity and coordination of globally distributed users by executing project activities with real-time information that updates automatically through direct links to tasks, documents, deliverables and other data sources. This automatically completes Design Control deliverables for the resulting Design History File (DHF). These automatic updates allow project managers to focus on high value activities rather than tracking down status.
ENOVIA Life Sciences Accelerator for engineering design manages all of the elements of a Medical Device company’s QSR (Quality System Regulation) and ISO-regulated design control data within a single, integrated system. This includes product data such as mechanical and electrical Bills-of-Material (BOMs), CAD models, configurations and related documentation such as drawings, specifications, procedures and quality standards. It also provides a mechanism to gather all information related to products and parts as they are collected and processed throughout other process areas of the PLM system. At the same time, it provides full audit trails and powerful authentication controls for compliance to international electronic record and electronic signature regulations.