PROJECT AND DHF MANAGER - Dassault Systèmes · PDF filePROJECT AND DHF MANAGER ... tasks, documents, deliverables, and other data sources. These automatic updates allow the project

PROJECT AND DHF MANAGER

OBJECTIVE Project and DHF Manager manages new product development projects, design activities and content with automatic creation of the device design history file to satisfy regulatory standards for good manufacturing practices for design control.

OVERVIEWProject and DHF Manager’s advanced resource planning, flexibility and templates make it possible for a company to automate resource planning activities. Its collaborative project management capabilities dramatically increase productivity globally by executing projects and programs with real-time information that updates automatically through direct links to tasks, documents, deliverables, and other data sources. These automatic updates allow the project or program manager to focus on high-value activities rather than tracking down status.

With Project and DHF Manager, companies can provide global teams with the accurate, real-time information they need to keep projects on track and respond to ever-shrinking product lifecycles. Through project pipeline dashboards, Project and DHF Manager provides management with real-time visibility into a project’s status in terms of overall schedule, phases, gates, resources, costs and benefits. Ultimately, this allows for better decision making when analyzing which projects offer the highest potential return on investment. Organizations can concentrate critical resources on those products deemed most necessary by the executive staff (e.g. new business unit technology introduction, profitable product line portfolio products).

Project and DHF Manager is most commonly implemented in the medical device industry, which places a priority on quality. Poor quality can literally be a matter of life and death in its worst case. Because of the risks involved in the development of novel medical devices, due diligence is of the upmost importance in terms of quality control measures. These competing priorities—quality and time-to-market— must be well managed through a careful process in order to reduce the risks inherent in the medical device industry.

Companies can provide global teams with the accurate, real-time information they need to keep projects on track and respond to ever-shrinking product lifecycles. Project and DHF Manager provides management with real-time visibility into a project’s status in terms of overall schedule, phases, gates, resources, costs and benefits.

HIGHLIGHTSKey features and capabilities include:

Project Standards Project managers can develop process standards by using templates. 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. The templates include a phase-gate decision making process to guide decisions to approve or cancel a project, gate exit criteria and product development milestones. Pre-configured process scheduling templates can define activity dependencies and slack time, task constraint dates & types, mandatory or optional use of tasks, documents that are needed with deliverables, and project role assignments.

Key benefits:• Save time and reduce compliance risks.• Improve and standardize business processes.• Provide real-time access to project pipelines

for rapid analysis and decision-making.• Define an integrated master plan combining

project schedule and budgets.• Manage and synchronize design documents

activities into a traceable Design History File (DHF).

• Link all parts of the organization together to provide full visibility of all product related information

• Expose potential bottlenecks in real-time to bring a product to market.

• Improve execution and oversight of complex product development activities by managing the overall work as a hierarchy of smaller interrelated projects.

Define ProjectsProject and DHF Manager organizes and manages a company’s product portfolio and executes development projects related to the planning and introduction of future products. Project managers can define complex project hierarchy and schedule project phases, milestones, and dependencies. Project managers can associate project to products, product releases with development projects and easy navigate design history file and its content.

Resource PlanningProject managers define project resource plans by project phases or over a project time-line in either weekly or monthly intervals. 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 managers can leverage a number of resource planning reports to help increase resource utilization, eliminate bottlenecks and improve resource assignment decisions.

Project ScheduleProject and DHF Manager can define product development and design work activities. It is used to define task dependencies and constraints and perform schedule what-if analysis. An editable Gantt chart includes estimated dates and durations and sub-projects with task interdependencies between subprojects. Project experiments allow project leaders to create alternate schedules for projects and author schedule alternatives without affecting the approved baseline schedule. The schedule alternatives can then be compared and merged with the approved baseline schedule to create a new baseline.

Project and DHF Manager 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. 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. The DHF provides dynamic links to related documents and data for improved visibility into related business processes, assigns design activities to team members, email task assignments with details of tasks, and configures preferences for task reminder.

My CalendarThe “My Calendar” view helps users to manage their assignments by providing a consolidated view of Project WBS Tasks, Risks, Issues, Meetings and Route Tasks. The user assignments can be visualized in daily, weekly and monthly views based on task due date and start date. From these views the users can directly access to assignment properties through right mouse buttons and work on their tasks.

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.

Design History File (DHF) ManagementThe DHF is assembled as design activities and deliverable artifacts are completed. Project content and deliverables are managed and stored 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. Project managers can easily to maintain DHF with Cut & Paste capabilities. Visual Cues of Outdated Content can be easily updated to insure only the most update document is used. Baseline & Revise Design History File can be set up.

Project DashboardsVisual cues are used to monitor tasks that are late or upcoming for proactive and intelligent decision making with real-time data.

Issue / Risk ManagementIssue 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.

Complete Project FinancialsProject leaders can define a financial plan for each project. The financial plan includes the project budget and project benefit (ROI). The project budget will detail 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 will see the return on the project over the timeline. Project leaders have the ability to toggle between multiple monetary currencies.

Collaboration & ApprovalsUsers can benefit from a wide range of capabilities for global enterprise collaboration. Those capabilities include the ability to manage and organize shared documents and structured product data. They also enable the creation of digital workspaces for virtual teams to work together. Users can easily raise issues, organize meetings and track decisions while any object lifecycle modifications can be formally approved using routes defined by end-users, or to simplify and facilitate a repeatable approval process, standard route templates.

Microsoft IntegrationUsers can create and access 3DEXPERIENCE data from the most popular Microsoft applications: Word®, Excel®, PowerPoint®, Outlook®, Windows Explorer, and Windows Desktop Search. This capability enables enterprise-level collaboration while not disrupting the established productivity of end-users. With product content being managed in 3DEXPERIENCE rather than on users’ PCs, organizations are able to create, manage, and review product content more securely.

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Our 3DEXPERIENCE® platform powers our brand applications, serving 12 industries, and provides a rich portfolio of industry solution experiences. Dassault Systèmes, the 3DEXPERIENCE® Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported. Dassault Systèmes’ collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world. The group brings value to over 190,000 customers of all sizes in all industries in more than 140 countries. For more information, visit www.3ds.com.

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