Medical Device: Definition Phase


How MasterControl Supports the Cross-Functional Development Team of a Medical Device Company during the Definition Phase

During the definition phase, development engineers focus on finalizing the design input requirements (DIR), so that the design can be frozen. As during previous phases, all other teams (research, development, regulatory, etc.) provide input. The design cannot be frozen until the entire cross-functional team signs off on it. As is also true during previous phases, there are an enormous number of documents that must be controlled and managed.

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Definition Phase Software Solutions

  • MasterControl Documents
  • MasterControl Collaboration
  • Controlled Documents Managed in the Definition Phase Collaboration Workflows in the Definition Phase
    • DIR
    • FMEA document(s)
    • Testing protocols
    • Regulatory guidances and best practice standards
    • Sales and marketing data collected during earlier product lifecycle phases
    • Design specifications
    • Intellecutual property documents
    • Regulatory documents
    • Quality documents
    • Resource plans
    • Business operations plans
    • User/market needs documents
    • Other market research documents
    • Collaboration documents
    • Design and Development Pland (DDP)

    Finalize DIR/ Freeze Design: In their effort to finalize the DIR so that the team can freeze the design, development engineers collaborate with team members from virtually every other department.

    • Research engineers, if their help is needed, collaborate with development engineers on the design verification test protocols.
    • Regulatory team members advise development engineers on additional testing needs, per regulatory guidances and standards.
    • Quality engineers continue to work with development engineers on critical risk factors.
    • Manufacturing engineers continue to collaborate with the development team in a concurrent engineering effort.
    • Sales and marketing professionals help finalize the DIR by verifying that what engineering has translated into a design meets user and market needs.

    Benefits of MasterControl Document Management Software

    • Secure, centralized virtual vaults provide effective management of design input requirements (DIR) during the product definition phase.
      • A centralized document repository makes it easy for authorized users to search for and retrieve the most recent version of the DIR.
      • It also facilitates the retrieval of documents during inspections and audits.
      • Security features such as dual passwords, password expiration, and encryption secure data communications between the web browser and MasterControl applications.
    • DIR, FMEA, test protocols and reports, specifications, and other documents created or reviewed during this phase reside in the draft vault while being worked on, and, when approved, automatically move to the approved/ released vault.
      • This prevents unauthorized design control documents or FMEA documents from being accidentally released.
      • It makes it easy to locate documents in the DHF to determine their status.
      • It also avoids duplicated effort. A document under revision can be locked to prevent multiple users from simultaneously making the same changes to the document.
    • Automatic archiving and cataloguing of outdated documents provides a GxP-compliant audit trail.
    • Because the software is web-based, DIR documents, FMEA documents, and other documents necessary to the product definition phase can be accessed by authorized users from any location.
      • This capability facilitates collaboration with experts outside the company.I
      • It also enables off-site employees to access documents on which they are collaborating.
    • Software generates standard or customized reports in real time both on the fly, and at regularly scheduled intervals to keep members of the cross-functional team up-to-date.
    • Notifies collaborators immediately when tasks are routed to them. This feature is particularly helpful during the definition phase, when all departmental teams are responsible for providing input to the DIR.
    • Automates routing, delivery, escalation, and approval of documents and tasks.
      • Provides the ability to create both linear and embedded workflows (where multiple employees sign off on the same step before proceeding to the next step).
      • Provides electronic approval capabilities and signature manifestation (per FDA requirement).
      • If necessary, escalates tasks to next level of responsibility to avoid bottlenecks.
    • Analytics capabilities and online charting are also provided.
    • Autoload feature allows users to drag and drop new documents into preconfigured network folders, making it easier to load documents into the system.

    MasterControl Collaboration Software Benefits

    • Provides a web-based, virtual workspace for collaboration.
    • Avoids the need for time-consuming face-to-face meetings among cross-functional team members collaborating on the DIR and other design documents.
    • Enables team members who may be offsite to collaborate.
    • Facilitates collaboration with experts outside the company.
    • The ability to chunk data for particular audiences or purposes facilitates collaborating with outside resources.
    • Creates system transparency, allowing authorized users to see where design control documents are in the workflow.

    Contact MasterControl Today to Learn More About Medical Device Definition Phase

    To get more comprehensive detailed solutions about definition phase involved in medical device companies, contact MasterControl representative today.