Governance

Allows companies to launch enterprise-wide new product introductions on-time and on-budget.

ENOVIA Life Sciences Accelerator for Product Introduction Experience

Provides project team members with real-time access and visibility to their projects and their assignment across the global enterprise.

ENOVIA Life Sciences Accelerator for Product Introduction Experience allows global project team members to collaborate and report status on their assigned project tasks and deliverables. Once design deliverable are completed they are automatically included in the design history file, which is mandated by U.S. FDA regulation 21 CFR 820.30(j) for quality audits and traceability purposes. Project members get real-time access and visibility to their project and assignments via stage gate and “swim lane” reports, raise risks and issues, and collaborate with cross-functional team members on project deliverables.

  • Collaborate on task deliverables with real time reporting on actual status for assigned project tasks
  • Mitigate and report status on assigned project risks
  • Capture and execute ad-hoc project issues
  • Visual displays of the deliverables, stages and functional area responsibilities to enable on-time completion of all design control activities
  • Viewing and filtering of project deliverables that compose the Design History File (DHF)
  • Manage Task Assignments
    Project team members are provided with a consolidated list of their assigned project tasks from all the projects they are members. Project members can filter their tasks based on completion status.
  • Project Visuals
    Members can leverage advanced visual project tracking dashboards to maximize visibility and effectively manage assigned deliverables and tasks. “Swim lanes” provide a birds-eye view of each project organized according to functional responsibilities. The “Stage Gate” view allows members to drill down into sections of the project and down to the individual tasks and deliverables.
  • Project Content
    Team members can establish a single environment for managing and sharing all project information—not just documents. By subscribing to document events, members are 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.
  • Team Collaboration
    Project members can create ad-hoc routes or workflows to circulate tasks, projects, and files for further work and/or approvals and conduct online discussions regarding a project or task. 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.
  • Design History File and Product Dossier Tracking
    As project members complete their activities and their associated deliverables for a project, the Design History File (DHF) is automatically generated 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 the user. The Design History File provides dynamic links to related documents and data for improved visibility into related business processes.
  • View Project Progress
    Project users can view the progress of their projects with “swim lane” and “stage gate” reports. The “swim lane” report provides a birds-eye view of each project organized according to functional responsibilities. The “stages gate” report view allows users to drill down into sections of the project and review individual tasks and deliverables.