Life Sciences
Life Sciences companies of all sizes face a competitive marketplace where it is vital to deliver innovative new products while ensuring compliance with increasingly stringent federal regulations that govern every aspect of design and manufacturing. To continually deliver successful new products to market, companies need to drive innovation, streamline business processes and improve collaboration globally.
The ENOVIA Life Science Accelerators provide years of Life Sciences industry experience with best-in-class collaborative business processes to ensure a successful, FDA and ISO compliant product rollout. Whether you are in the medical device or another life sciences product development industry ENOVIA can help you to streamline business processes and reduce new product development time.
ENOVIA Life Sciences Accelerator
For Product Introduction
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.
Features Include
- Product Line Management
- Project Work Breakdown Structure, Task Deliverables plus Issue & Risk Management
- Team Collaboration
- DHF & Product Dossier Tracking
Key Benefits
- Bring industry-leading products to market more quickly and reliably
- Increase executive visibility across all projects
- Improve quality and consistency of document deliverables to reduce regulatory risk
- Automatically generate the structure of the DHF using templates
- Satisfy Quality System Regulation (QSR)/ISO regulatory requirements and achieve Six Sigma objectives
ENOVIA Life Sciences Accelerator
For Change Control
ENOVIA Life Sciences Accelerator for Change Control manages modifications to all types of Quality System Regulation (QSR) and ISO regulated documents, procedures and specifications throughout an organisation. 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.
Features Include
- Change Documentation & Impact Assessments
- Implementation Action Plans
- Process Approvals
- Part 11- compliant electronic Change Control process
Key Benefits
- Manages modifications to all types of Quality System Regulation (QSR) and ISO regulated documents, procedures and specifications
- Automatically enforces critical change control business rules
- Aging report provides visibility to the status of the changes and help identify bottlenecks
ENOVIA Life Sciences Accelerator
For Quality Issues
ENOVIA Life Sciences Accelerator for Quality Issues manages quality issues through a single, global, on-line system, which provides insight into the health of your Quality System. Companies can avoid compliance risk, reduce waste, and increase the ability to leverage quality information for improving related business processes. ENOVIA Life Sciences Accelerator for Quality Issues addresses four critical concerns: Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NCRs), Product Complaints, and Quality Audits.
Features Include
- CAPA Management including Initiation, Root Cause, Remediation and Monitoring
- Non Conformance Reports
- Product Complaints Management
- Quality Audits
Key Benefits
- CAPA capabilities provide comprehensive management of the quality investigation
- Product Complaint capabilities include automation for developing action plans and delivering requisite regulatory submissions
- NCR capabilities provide control over manufacturing nonconformance including containment, bounding investigations, proposed and actual dispositions and verification activities
- Fully integrates the capture and tracking of all quality incidents and the subsequent investigations
ENOVIA Life Sciences Accelerator
For Engineering Design
The ENOVIA Life Sciences Accelerator for Engineering Design gives companies the ability they need to manage the vast array of product data centrally including bills-of-materials (BOMs), product specifications, and Device Master Records (DMRs).
Features Include
- Part & CAD Data Management
- Bills of Material (BOM) Management
- BOM Alternates & Substitute Parts
- BOM Markup and Compare
- Engineering Change and Device Master Record (DMR) Management
Key Benefits
- Respond rapidly to market opportunities by streamlining product development and change processes
- Improve quality and consistency of design control deliverables by dramatically reducing regulatory risk
- Satisfy QSR/ISO regulatory requirements for DMRs
- Satisfy Federal Drug Administration (FDA) Part 11 requirements with a full audit trail and signature authentication controls
Downloads
Datasheet: ENOVIA Life Sciences Accelerator for Product Introduction (1.0Mb)
Datasheet: ENOVIA Life Sciences Accelerator for Change Control (1.6Mb)
Datasheet: ENOVIA Life Sciences Accelerator for Quality Issues (1.6Mb)
Datasheet: ENOVIA Life Sciences Accelerator for Engineering Design (2.1Mb)
Whitepaper: How PLM Provides a Competitive Advantage for Life Sciences Companies (0.4Mb)