The Governance domain allows companies to launch enterprise-wide new product introductions on-time and on-budget. Within Governance are these sub-processes: Requirements Management, Portfolio Configuration, Program Management, Decision Support Business Intelligence, and Compliancy.
ENOVIA Life Sciences Accelerator for New Product Introduction
ENOVIA® Life Sciences Accelerator™ for Product Introduction enables program and project managers to create a competitive advantage by delivering products from concept to market faster.
ENOVIA® Life Sciences Accelerator™ for Product Introduction provides advanced project management capabilities for Life Sciences companies to institutionalize best practices in executing new product introduction projects. It helps coordinate project activities and deliverables to ensure completion of design control deliverables and automatically tracks the resulting Design History File (DHF). Project managers are provided with advanced visual project tracking reports to maximize management visibility and control. By implementing ENOVIA Life Sciences Accelerator for Product Introduction, companies will improve time-to-market, avoid regulatory risk, and improve operational excellence.
When ENOVIA Life Sciences Accelerator for Product Introduction is implemented, the following benefits are realized:
Deliver Market-Leading Products
Organizations can bring industry-leading products to market more quickly and reliably by focusing on the creative aspects of design rather than administrative details. Product teams can easily collaborate with various contributors and stakeholders to plan projects, develop designs, expedite documentation and release new products. It also increases executive visibility across all projects and institutes clear accountability across all project teams.
Drive Responsive Execution
Organizations can respond more quickly to market opportunities by streamlining product design, submissions and production ramp-up. Complete more projects on time and budget by automating project execution, visibility to dependent projects, reusing available information and avoiding unnecessary setbacks.
Achieve Lean Quality and Compliance
Organizations improve quality and consistency of document deliverables to dramatically reduce regulatory risk and avoid audit findings. Organizations can satisfy QSR/ISO regulatory requirements and achieve Six Sigma objectives through enhanced process control, metrics and real time reporting.
- Provides real-time access to project pipelines for rapid analysis and decision making.
- Embeds compliant best practices and Critical-To-Quality (CTQ) drivers into standard, repeatable project templates
- Provides highly visual views on the deliverables, stages and functional area responsibilities to enable on-time completion of all design control activities
- Automatically generates the structure of the DHF
- Exposes resource bottlenecks in real-time with enhanced management visibility.
- Increases resource utilization and reduce conflicts between project managers and functional group managers.
- Drives phased-based decision making processes using best-in-class process templates, with predefined phases, gates and milestones.
- Improves execution and oversight of complex product development activities by decomposing projects into smaller manageable projects with visibility to sub-project dependencies.
- Facilitates access to processes and data within a secure environment.
- Coordinate and collaborate on the planning and execution of projects in real-time.
- Manages complex collaborative projects involving internal and external teams of prospects, customers, suppliers, and partners.
- Tracks meetings, decisions, and artifact baselines so that traceability is established for historical reference.
Business GoalsManagers can define a business goal hierarchy to help identify which projects to approve and fund based on how they impact strategy.
Design History File and Product Dossier TrackingENOVIA Life Sciences Accelerator for Product Introduction automatically tracks the activities and deliverables to generate the resulting DHF in accordance to U.S. FDA regulation 21 CFR 820.30(j). Project deliverables can be viewed according to a number of configurable criteria to show only those deliverables that are most important to you. The DHF provides dynamic links to related documents and data for improved visibility into related business processes.
Advanced Resource ManagementENOVIA Life Sciences Accelerator for Product Introduction enables companies to optimize global resource staffing plans for strategic projects and reduce cycle times by implementing best-in-class business processes. Project managers can define project resource plans by project phases or over a project time-line in either weekly or monthly intervals. Plans are submitted to functional group managers for fulfillment. During the resource planning definition process, a project leader can define the estimated resource costs. Each submitted resource request identifies the business skills to ensure that the right people are assigned to the project resource request. Functional group managers have real-time visibility to all submitted requests in order to assign available people within their organization or to even reject a request. Functional managers can also leverage a number of resource planning reports to help increase resource utilization, eliminate bottlenecks and improve resource assignment decisions.
Project DashboardsManagement can leverage dashboards that provide a graphical view of the project schedule of phases, gates, and milestones, and a roll-up of risks, quality, assessments, issues, costs and benefits. More detailed information can be easily navigated from the dashboard summary.
Project TemplatesProject managers can develop process standards and enhance predictability by driving repetitive project execution throughout the organization. The project template consists of a work breakdown structure defined with phases, gates, milestones, and tasks with dependencies and responsible roles. Project templates can also include folder structures for storing content, questionnaires, document and deliverable templates, project budgets, resource plans, and bookmarks.
Work Breakdown StructureProgram managers can decompose complex product development activities into smaller manageable subprojects. Project leaders can then define schedules to organize global project teams into phase-gate activities that take into consideration assigned project members' roles and non-working days. ENOVIA Life Sciences Accelerator for Product Introduction supports all phases of development, including the ideation phase in which organizations evaluate the likely value and feasibility of all potential new projects. Once each concept is approved, it is updated to a formal project and can be planned in detail. ENOVIA Life Sciences Accelerator for Product Introduction provides bi-directional integration to Microsoft Project for project managers that prefer using a Microsoft Project user interface for editing schedule information.
Phase Gate ManagementProject leaders can manage a company’s processes with a phase gate review process, which includes criteria for making decisions to fund or not fund a project. For historical traceability purposes, the project leader can schedule the gate review meeting date and capture the gate meeting details such as list of attendees, topics and artifacts, and final decisions.
Task DeliverablesAs tasks are assigned and being worked, task deliverables should be associated and managed in the context of the task. As a deliverable is promoted through its lifecycle, the system automatically updates the task status. After the tasks are completed, project folders store and categorize the deliverables for access controls and increased visibility. To keep task deliverables on schedule, project leaders can configure automatic reminders of upcoming or late tasks that project members will receive in their company email.
VPM Project ManagementFor companies using ENOVIA® VPM Central™, it is possible to monitor design activity and navigate all project information from CATIA using ENOVIA Life Sciences Accelerator for Product Introduction. This allows access to outputs from design on the corresponding project tasks. In V6, ENOVIA Life Sciences Accelerator for Product Introduction and ENOVIA VPM Central both run on the same technology platform. Therefore, users can search for and associate VPM data as deliverables to assigned project tasks easily. VPM tasks can be created as part of the ENOVIA Life Sciences Accelerator for Product Introduction Work Breakdown Structure (WBS) and are accessible immediately to the designer within his design environment.
Product Line ManagementENOVIA Life Sciences Accelerator for Product Introduction organizes and manages a company's product portfolio and executes development projects related to the planning and introduction of future products. Product lines and model hierarchies organize a company’s family of products. Model hierarchies represent specific products available to customers. Product managers can associate product releases with development projects and easy access and navigate design history file and its content.
Schedule Product BuildsPrototype and production builds represent key milestones of the product development process. Multiple builds can be identified and planned for a particular product, and then their completion can be tracked through the project schedule.
Project ContentAll project content and deliverables are managed and stored securely within controlled and uncontrolled folder and subfolder structures. Security is established on a per-project basis. Project owners and project leads determine individual access rights. Within a project, each folder and file maintains additional levels of security. Lifecycle controls establish folder content baselines as a means of measuring project performance and historical references. Team members can establish a single environment for managing and sharing all project information —not just documents. By subscribing to folder and document events, members can become informed immediately as changes and additions occur. Reports provide a consolidated list of project-related content from either the work breakdown structure or from the folder structure.
Project FinancialsProject leaders can define a financial plan for each project. The financial plan includes the project budget and project benefit. The project includes project capital and expense categories and items, along with actual costs. The project leader can also define the financial benefits the project will deliver over a defined timeline. Project leaders have the ability to toggle between multiple monetary currencies.
Team CollaborationA project manager can institute standard reviews for project members using routes or workflows to circulate tasks, projects, and files. The entire project team can be kept informed of important project information with online discussions. All team members can subscribe, view, and comment on the original discussion topic or any of the subsequent responses.
Issue / Risk ManagementIssues are real incidents, inquiries, or problems that impact a project negatively, and risks are anything that can potentially impact a project negatively. Issue management provides a context for capturing, tracking, and closing issues in the context of a project. Issues are identified, captured, classified, and assigned to project members for resolution. Risk management enables project teams to identify, quantify, analyze, and mitigate project risks. During the analysis process, risks need to be assessed and quantified in two dimensions. These two dimensions are impact and probability with ranges from 1-5. These dimension values help minimize these potential negative impacts by determining each risk priority and clarifying which project risks need mitigation.
Critical To Quality (CTQ)To ensure that projects meet customer requirements, project teams can define and measure a project's CTQs. These are the key measurable characteristics in which performance standards or specification limits of a product or process must be met in order to satisfy customer needs.
Project Meeting TraceabilityProject or program managers can capture meeting details to maintain artifacts for historical references. Managers can define meetings, and track who was invited and who actually attended. Agenda topics can be added to meetings with time durations allocated for each topic and associated document attachments for discussion. Issues that need further follow up and recorded decisions are stored as an outcome of the meeting.
Weekly Time TrackingProject users can enter hours worked on a project or a task during the week, and submit them to either the functional manager or project manager for approval or rejection. ENOVIA Life Sciences Accelerator for Product Introduction provides time reports by project phase or by project member to track worked hours for assigned tasks. By capturing a user’s time throughout the week in a time sheet, the project manager has accurate status information, can project future progress, identify potential risks, and take the necessary actions to readjust the schedule or resources.
The Role of ENOVIA V6 and PLM 2.0ENOVIA Life Sciences Accelerator for Product Introduction supports PLM 2.0, product lifecycle management online for everyone, and the ENOVIA V6 values, which are: • Global collaborative innovation • Single PLM platform for intellectual property (IP) management • Online creation and collaboration • Ready to use PLM business processes • Lower cost of ownership.