Table of Contents

Overview

The Project in QbDVision is a record itself and contains all the relevant information and records for your project. Five sections define the project: Project, Purpose, Development, Regulatory, and Team.

Key Concepts

Project

The Project section contains fields to enter the Name, ID or Program number, Type, Category, Risk Management Plan and Product Risk Assessment Type. There is also a section to upload any source documentation for this program.

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Purpose

The Purpose section contains fields to describe the Purpose and Scope of the project further, as well as the overall objectives.

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Development

The Development section contains fields to describe which phase in the product’s lifecycle the project is in. There are fields to track the Quality-by-Design Phase, CMC Phase and Validation Phase.

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Regulatory

The Regulatory section contains fields to describe Regulatory-related information. There are fields to capture Dosage Form, Route of Administration, Regulatory Path, Regulatory Phase, and Listed Drug Reference.

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Team

The Team section is where team members who play a specific role can be defined. There are roles for CMC Lead, QA Lead, and Regulatory Lead, to name a few. The Project Sponsor and Project Manager fields are required for proposing the project record.

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Dashboard

After a Project is created, a Dashboard will be created with standardized menu options to access Product information, Process information, etc. Additionally, the dashboard will display any records in Draft or Pending Approval.

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Frequently Asked Questions

I don’t see the correct people available in the Team section. How can I select the appropriate people?

Users must be added to the Project before they’ll be available for selection in the Team section. To add users to a project, please contact your administrator.

How can I change my Risk Management Plan?

Click Edit Last Draft on the Project record and select the appropriate Risk Management Plan.

What is the difference between the project purpose source documents and project source documents?

In the project section, you may include a product development plan if that is something you or the sponsor might draft. For the Project Purpose or Objectives, you might include other documents that summarize the planned activities with respect to these specific concepts. The software provides the capability to attach documents but it does not necessarily have to be used.

What does proposing and approving the project do? Does it make it read-only? When it's approved and someone edits it and makes a draft, can only they and administrators see the draft?

Think of the Project record as a living project charter. You can use it to track the stage of the product development activities by the different fields provided (e.g. QbD Phase, CMC Phase, etc.). Approving the record only approves the information in the record but not all of the information in the overall project.  

There are a lot of justification and information sections that aren’t all required. Is it typical to fill all of these out in a completed project?

QbDVision is very flexible in that you fill out the information you have at the time and use what you need.  If you find an area of the product that does not pertain to you, leave it blank.  There are required fields for save (*) and propose (**) and beyond that, use what makes sense.

Is there a way to finalize the project when everything is complete? If so, what does that look like?

The only way to finalize a project is to have all records approved. The project dashboard has a mechanism to perform bulk approval operations.

Approved vs. non-approved projects. What is the approval process at the Project level?

Think of the Project record as a living project charter. You can use it to track the stage of the product development activities by the fields provided (e.g., QbD Phase, CMC Phase, etc.). 

Approving at the Project level means you approve the Project, Purpose, Development, Regulatory, and Team sections in the Project record.  Approving this record does not affect your Product or Process records.

How are Projects versioned? Do they need to go through the approval process for simple changes? If there are several Processes in a Project and one has some changes, does the entire project get approved again?

It’s best to conceptualize a Project record as a charter. While the Project (or charter) can be approved for each version, all you’re approving at the Project level is the record's contents. That approval does not have a technical impact on your Product or Process records.

You may, however, assign organizational significance to the approval as part of your processes and SOPs. 

Each record has its approval and edit history. For example:

In v0.1, you see where the Project was created, but has no Source Documents.  

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Here in v0.2, you see where the Source Documents were added. Each time a record is edited, a minor version is created.

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Here you can see major versions for this FQA, Aggregation.

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How do the Phases in the Development section of the project align with this chart?

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The CMC Phase-related activities align with the Development Activities in this chart (shown in dark blue).  The Process Validation Phase for a product aligns with the Process Validation Stages of this chart (shown in green).  We will be updating the phases in the project dashboard to align with this chart as well as changing the Process Validation dropdown to be active for any CMC phase. 

The Quality-by-Design milestones (shown in orange) align with the standard development phases for any medicinal product, along the top of this chart (shown in gray). The milestones align with the ICH Guidance for Drug Design and Development. By following the QbD milestones in alignment with the development phases from pre-IND to commercial, a control strategy framework is achieved. Ultimately, this Control Strategy Framework facilitates better communication between those involved in risk-based drug development and drug application review.