Governance

Governance

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 Product Introduction

ENOVIA® Life Sciences Accelerator™ for New Product Introduction provides advanced project management capabilities for Life Sciences companies to institutionalize best practices in executing new product introduction projects.

ENOVIA Life Sciences Accelerator for New Product Introduction makes it possible for companies to institutionalize best practices for management of all product introduction projects for a company’s product portfolio. This collaborative project management solution dramatically increases the productivity and coordination of globally distributed users by executing project activities with real-time information. Updates occur automatically through direct links to tasks, documents, deliverables and other data sources. This action ensures completion of design control deliverables and the automatic tracing of the DHF. These automatic updates allow project managers to focus on high value activities rather than tracking down status.

Project managers are provided with advanced visual project tracking reports to maximize management visibility and control. By improving time-to-market and regulatory compliance within product introduction projects, companies maximize efficiencies and reduce collaboration costs.

 

When ENOVIA Life Sciences Accelerator for New 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.

  • Manages any number of new product development projects, activities and deliverables
  • 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
  • Enables easy, real-time visibility into all the critical projects in your organization via a visual dashboard
  • Minimizes resource conflicts and bottlenecks through better management visibility of project resource requests from across the enterprise
  • Business Goals
    Managers can define a business goal hierarchy to help identify which projects to approve and fund based on how they impact strategy.
  • Advanced Resource Management
    Project managers can define project resource plans over a project time line in either phase, weekly, or monthly time intervals which are submitted to functional group managers for fulfillment. During the resource planning process, a project leader can define the estimated resource costs. Each submitted resource request identifies the business skills to insure 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.
  • Management Dashboards
    Management can leverage advanced visual project tracking dashboards to maximize visibility and control of all product introduction projects. The “swim lane” report provide a birds-eye view of each project organized according to functional responsibilities. The “stages gate” report allows managers to drill down into sections of the project and to the individual tasks and deliverables.
  • Project Templates
    Project 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 templates, project budgets, resource plans, and bookmarks.
  • Work Breakdown Structure
    Project managers can decompose complex product development activities into smaller manageable sub-projects. Project leaders can then define schedules to organize global project teams into phase gate activities that take into consideration assigned project member’s role and non-working days. ENOVIA Life Sciences Accelerator for New 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 New Product Introduction provides a bi-directional integration to Microsoft Project for project managers that prefer using a Microsoft Project user interface for editing schedule information.
  • Project Financials
    Project 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 time line. Project leaders have the ability to toggle between multiple monetary currencies.
  • Task Deliverables
    As 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.
  • Product Line Management
    ENOVIA Life Sciences Accelerator for New 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 organize them into portfolios. A portfolio provides visibility into a product line’s road map, product release dependencies and a real time status of strategic project milestones to share with other organizations.
  • Schedule Product Builds
    Prototype 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 Content
    All 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.
  • Design History File and Product Dossier Tracking
    ENOVIA Life Sciences Accelerator for New 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.
  • Team Collaboration
    A 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 Management
    Issues 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.
  • Project Meeting Traceability
    Project 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 Tracking
    Project 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 New 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 2.0
    ENOVIA Life Sciences Accelerator for New Product Introduction supports PLM 2.0, product lifecycle management online for everyone, and the ENOVIA V6 values: global collaborative innovation, single PLM platform for intellectual property (IP) management, online creation and collaboration, ready to use PLM business processes, and lower cost of ownership