Document Roadmap

Document release

"Release: 1.0" in the top left corner indicates the version of the documentation within the roadmap. There may be various other versions that allow tracking of changes and the development of documentation over time. The user can select a specific release to view the corresponding set of documents and their status at a given stage of the project.

Phases

The Document Roadmap consists of several main phases (represented as arrows):

Product Discovery This initial phase focuses on market research, planning, and evaluating the feasibility of the product.
Design Input The goal of this phase is to define all requirements, including technical, regulatory, and safety-related ones.
Design Development & Design Output The product design is developed in detail, tested, and documented. The outputs serve as the foundation for subsequent phases.
Design Verification In this phase, it is tested whether the design meets the specified requirements.
Design Transfer & Authorization Review This phase involves the final assessment and preparation for approval and product release. Documents include final validation reports, risk assessments, and regulatory documentation.
Maintenance This phase includes post-launch activities focused on product sustainability, ensuring compliance with new standards, and addressing any necessary changes.

Gates

Gate controls (Gate G10 to G70) are project milestones that verify whether all necessary requirements have been met and if the project can proceed to the next phase.

Why Are Gates Included?

They ensure systematic development, minimize risks, and guarantee compliance with regulatory requirement.
Gates act as structured checkpoints, providing oversight and helping to maintain quality and compliance throughout the product lifecycle.

Documents

Documentation serves as a record of decisions, fulfillment of requirements, and evidence of compliance with regulatory standards (e.g., ISO, FDA). Each phase has a specific set of documents that are mandatory for progression.

Document Status Indications

Documents are color-coded to indicate their status:

Green: The document is complete.
Orange: The document is in progress or requires an update.
Red: The document is critically incomplete or requires revision.

Gantt

A Gantt chart is a graphical representation of a project schedule that displays individual tasks or phases, their start and end dates, and their interdependencies. This view provides an overview of the document dependencies, including input and output documents, associated progress, and the criticality of tasks at various stages of the documentation process.

Header Section

The header section of this view remains the same as the previous DocuRoadmap representation, showing the phases of the project and milestones.

Let's describe the Gantt chart in the following image below:

Input Documents Panel (Left side):
- This panel displays the required input documents for the given output.
- Each document is associated with icons for detailed views, version history, or the option to edit or update.
Document Status Panel (Middle section):
- In the center, the active document is displayed (for example, Traceability: HRA to System Req.) with the following key information:
  - Milestone: This document belongs to the Design Input Review (G30) phase.
  - Progress Metrics:
    - Duration: 62 days, with 14 days remaining (64% completed).
    - Estimated total duration: 68 days.
  - Responsible Parties: Author, Reviewer, Approver
  - Additional Information:
    - Link to the document template And SOPs
    - Link to SOPs/WIs (Standard Operating Procedures/Work Instructions).
Output Documents Panel (Right side):
- This panel shows the documents that are the output of the given document:
  - Artefact Review Design Input (Status: Red - Critical).
- Displays the completion percentage of this document (for example, 85% complete).

In the top-right corner of the header, you can switch to the graphical view of the Gantt chart. This view makes it easier to understand the dependencies and status of individual documents.

Colors and Their Meanings in the Diagram:

Purple: The central document (in this case, "Design Transfer & Design Validation") is highlighted in purple and serves as the main node of the system.
Green: Input documents connected to the central document. These are further categorized by levels (L1–L3).
Turquoise: Output documents that originate from the central document. Like input documents, they are labeled with levels (L1–L3).
Gray: Documents that have not yet been activated or processed.
Lime: The document we have just activated.
Darker Shades: The darker portion of a document's bar represents the completed part. For example, "Traceability: HRA to System Req." is 65% complete. You can adjust this portion to modify the percentage of completion, which is also reflected in the summary table on the left.

Interactivity:

Each document has an icon to expand or collapse its dependencies:

(+) Allows you to expand the document and view its dependencies.
(-) Indicates that the document is currently expanded.
(/) Indicates that the document has no input or output dependencies.

Overlap Between Documents

This diagram explains how the overlap between input and output documents affects the overall duration of the project. The percentage of overlap determines how much work on the next document begins before the previous document is completed. The overlap ranges from 0% (no overlap) to 100% (simultaneous work).

The effect of percentage overlap (0%, 50%, 90%, or 100%) on the project duration is illustrated:

No Overlap (0%)
Work on the output document starts only after the input document is 100% completed.
Partial Overlap (50%)
Work on the output document begins when the input document is 50% completed.
Larger Overlap (90%)
Work on the output document begins when the input document is 10% completed.
Full Overlap (100%)
Work on the output document begins simultaneously with the input document.