Doc Builder
- Luke Guerrero
- Jean Marie Schiraldi
- Adrienne O'Reilly
Table of Contents
Overview
Doc Builder is a tool that helps users draft documents within QbDVision. Documents created with Doc Builder can be integrated with Project data located within other modules of the platform. Doc Builder ties documents to the single source of truth and stores them within the centralized QbDVision platform, making them easier to find and update as the Project evolves through all phases of the lifecycle.
To access Doc Builder, users will select the “Draft in QbDVision" button in the document record.
Doc Builder has various capabilities, such as intelligently extracting data from different records in QbDVision and surfacing it in the QbDVision Doc. Doc Builder was created to enable users to draft directly in QbDVision and integrate existing data on the platform, increasing data management efficiency and accuracy. Many features within Doc Builder come together to achieve this.
Video Tutorial
Key Concepts
External document vs. QbDVision Doc
Users can use a Document record to store and manage an external document or opt to draft the source document in QbDVision directly using Doc Builder.
External document
An external document is any document that a user uploads from a source outside of QbDVision. Users can upload a PDF as the final document in the document record as well as upload additional external documents as supporting documentation in the source documents section.
QbDVision Doc
A document created using Doc Builder is a QbDVision Doc. With Doc Builder, users can create a QbDVision Doc as a source document. A PDF is automatically created when a user proposes the Document record for approval. Users can download a QbDVision doc as a PDF from the Doc Builder.
If a user uses the QbDVision Doc and wishes to revert to using an external document, they can do so by clicking on ‘Use External Document’ at the top right of the card.
Smart Content
Smart Content is content in a QbDVision Doc that is dynamically linked to the data in various records of the QbDVision platform. In other words, Smart Content is living content. Any time there is an update in the data at the source, it is pulled into the QbDVision Doc.
A user can click on the QbDVision icon in the toolbar to open the Smart Content and Widget menu, then navigate through the menu to insert Smart Content into their document.
Once inserted, the Smart Content will look like this in Edit mode:
Smart Content then directly pulls the respective data into the document. It will pull the data from the latest draft. This data is live, which means any time there is a change in any data, Smart Content will automatically update in the QbDVision Doc.
Using the Smart Content tab (i.e., Direct Scope)
First, users can add individual fields of Smart Content directly in-line with text by selecting any option available in the menu tab labeled “Smart Content”. Inserting Smart Content in this tab provides users with the most flexibility when drafting a document. It is also known as inserting Smart Content with direct scope, as no additional information is required for the record data to render.
Using the Widget tab
The second way to insert Smart Content is through the “Widget” tab in the menu. A widget should be built when there is a pattern and consistent structure to the information within a document. For example, the Process Description report details each Unit Operation performed in the Process. Within each Unit Operation, a detailed list of Materials and Equipment used within the Operation is provided, along with a list of Steps performed. By using a widget in the Process Description report, a user will only need to outline the structure of the Unit Operation section once to populate the data for all Unit Operations in the entire document, rather than typing or inserting every piece of smart content for each Unit Operation.
Nesting Widgets
Additionally, users can define different data scope levels by layering Table Widgets within Repeater Widgets and vice versa. For example, the user can create a table of Process Parameters with Target, LSL, and USL data displayed for a specific Unit Operation by following the steps below:
In the Widget menu, add a Repeater Widget, set the Model to “Unit Operation”.
Add the Unit Operation Name into the Repeater Widget by navigating to Process Fields > Unit Operation > Name in the Smart Content menu.
Add a Table Widget and set the Model to “Process Parameter” within the Repeater Widget.
Fill in the Process Parameter Table Widget with fields listed in the menu under Process Fields > Process Parameter (e.g., Name)
Within the Table Widget, add another Repeater Widget with the Model set to “Process Parameter” and the Submodel set to “Acceptance Criteria Range”.
Fill in the Repeater Widget with fields listed in the menu (e.g., Target, LSL, USL, Measurement Type, Measurement Units, etc.).
Note: For Material, Process Component, and Control Method Repeater/Table Widgets fields listed in the Smart Content menu under System Fields > Supplier, can be added directly.
Click “Save” to view your QbDVision Doc populated with specific data from the Process.
It is essential to note that when referencing information from a subsection of a record (e.g., data from the Acceptance Criteria Range subsection), nested widgets are required to display the data. For this data, users should first insert a widget with a specified model, then nest another widget with the same model and a specified submodel. The list below details record information that requires nesting widgets and selecting a submodel:
All submodels in the menu. These submodels include the following:
Supporting Documents
Risk Links
Control Method Links
Development Links
Training Links
Acceptance Criteria
Criticality Assessment
Widgets
Repeater Widget
The Repeater Widget allows the creation of a layout template for enumerating lists of information. This provides a powerful layout engine for working with groups of information.
For example, a Repeater Widget can be used in conjunction with a Unit Operation, allowing users to define the fields they want to display for each Unit Operation. The system will iterate through each Unit Operation in order and show the defined fields when rendering the Document.
Repeaters can be nested together. For example, users can define a Repeater: Unit Operation [Repeater: Steps] to list all Unit Operations and then all the associated Steps.
Table Widget
The Table Widget allows you to display a set of information in a table format. It expects the first row of the input to be the header and the second row to contain Smart Content fields. Attribute filters based on the Model or Submodel selected can be used to define criteria for the data that will populate the table.
The Widget Type, Model, and SubModel (optional) selected set the data scope for the Smart Content added. In most cases, for Smart Content to render properly, users must select Smart Content options from the header in the menu that matches the chosen model for a Table Widget. For example, in a Table Widget with “Material” as the Model, users must select Smart Content options that are listed under Project Fields > Material.
Document Versioning
Every time a user saves (by clicking the QbDVision Doc in Doc Builder), it gets saved as a separate version. Versions of the QbDVision Doc are a part of the Document record versions.
Automatic updates to the Smart Content will NOT affect the version history.
Approvals
A user can propose a Document record for approval at any point. The approval action is for the PDF version of the document, not the underlying QbDVision Doc.
To ensure this, when a user proposes a Document record for approval, the system checks if an existing PDF is created from the QbDVision Doc. If not, the system automatically creates a PDF and sends that to the approver for review.
In the case of an existing PDF, the system checks if updates were made to the QbDVision Doc after the PDF was uploaded. If there is a mismatch between the PDF and the QbDVision Doc, the system automatically updates the PDF to ensure the approver can review the latest data.
Frequently Asked Questions
How do I export a QbDVision Doc?
A QbDVision Doc can be exported as a DOC or a PDF using the Export button on the extreme right of the toolbar in the Doc Builder.
What happens if the project data used as Smart Content in a QbDVision Doc updates?
When project data, used as Smart Content in a QbDVision Doc, is updated, it will be reflected in the QbDVision Doc in real-time, even when the respective QbDVision Doc is not open.
Can I copy and paste the content from a Word document to a QbDVision Doc?
Yes.
Can I change the Project and/or Process associated with a QbDVision Doc?
This can be done in the About section of the Document record by selecting the “Edit” and then picking the new associated Product and Process.
It is essential to note that Smart Content is dynamically linked to specific Project and Process records. Therefore, changing the Process associated with a QbDVision Doc may impact the Smart Content's ability to render correctly. Whether the Smart Content link carries between projects and processes depends on how your Document is set up. For example, Widgets filtered using information unique to a specific process (e.g., record ID numbers) won’t carry over. However, copying a Document first and then changing the Process is a way for users to leverage templates created within Doc Builder for multiple processes.
Will documents uploaded in the project documents tab be available in the global documents section or only within the project?
A document created in a project is also available in the global documents section, accessible through “Documents” in the system-level menu.
If we already use PDFs for our documents, can we use the currently practical PDF as a template in the Doc Builder and then update these templates in the Doc Builder going forward?
No. With this new feature, users must select whether they want to upload a PDF as their source document or use Doc Builder to draft their source document within the software. To use the existing PDF as a template in Doc Builder, users must first convert the PDF to a Word document or a Google Doc, then copy and paste the content into Doc Builder. It is essential to note that the template will still require updates to include Smart Content fields, enabling the leverage of data in other areas of the software.
Do you have plans to make additional reports or templates available for Doc Builder in the future?
Yes. We currently offer users the option to start a new QbDVision Doc from a blank document, a Process Description template, or a Critical Quality Attribute Assessment (CQAA) report. We plan to add new capabilities and more templates, enabling users to leverage even more functionality within the platform.
Is the PDF/Word output from Doc Builder in a Submission-ready format, or do I need to cut and paste it into a format that can be submitted?
As seen when using the Process Description report template, Doc Builder can build a customized report and export it as a Word or PDF document. However, our editor still has standard formatting features (e.g., pagination, setting document margins, etc.). Furthermore, PDFs generated for eCTD submission have significant bookmarking and links to simplify the navigation of complex documents. Given the complexity of generating eCTD-ready PDF documents, we recommend using the QbDVision editor to finalize all document content. Then you can export it to a Word format for final formatting and bookmarking/tagging activities before converting it to an eCTD-ready PDF. As the document editor feature matures, additional capabilities will be added to enhance the formatting of reports and templates for submission. However, as regulatory agencies shift to more structured submissions, we anticipate that extended text-based narratives in submission documents will gradually be phased out over time.
Does Doc Builder retrieve information from the latest record? Or the latest Approved record?
Doc Builder retrieves information from the most recent record. If you have a v1.0 Approved record and a v1.1 Draft record, Doc Builder will retrieve the latest information from the v1.1 Draft record.
How can I add a filter to an existing widget?
Adding filters to existing widgets is not currently supported. The recommended workaround is to add a new widget for the same data with the filter applied and remove the old widget.
Why is the Smart Content I added rendering blank and not showing in my QbDVision Doc?
There are several reasons why Smart Content may render blank and not display any information after a QbDVision Doc is saved. The first reason is that the fields that the Smart Content are referencing are blank in the record and do not contain any information. Once the user completes these fields, the Smart Content will update automatically with the information once the QbDVision Doc is loaded. The second reason that Smart Content will not render properly is due to the setup of the Repeater and Table Widgets used. Instructions for how to properly add Smart Content and use Widgets are detailed in the Doc Builder Confluence Page in theDoc Builder | Smart Contentand,Doc Builder | Widgetssections, respectively. Please submit a ticket through the Support Portal if you require further assistance.
How do I delete a table within Doc Builder?
To delete rows, columns, and tables in Doc Builder, view this video walkthrough: https://www.loom.com/share/d72bf4923639444a8375b30dca0f8904?sid=2d33acc9-bf9e-4bee-8fce-b9cf4c027e9f
How do I make the page numbers render properly?
Page numbers will display in the footer of your QbDVision Doc once it’s been exported. This is because QbDVision Docs are initially created as a continuous document without pages. The system relies on exporting to paginate the document and assign page numbers. Watch this video walkthrough to see how: https://www.loom.com/share/90d67a23541948c2a0760713df99f142?sid=acbaeb41-ca60-4068-a3c9-9b4005f728e3
Can I make a numbered and multi-level numbered list in Doc Builder?
Yes! Place your cursor where you want to start your list and click on the numbered list in the toolbar, just to the right of the decrease indent button. That will insert the number 1. into your document.
To continue adding numbers, click number 1, so it is highlighted, and then click the dropdown arrow next to the numbered list button in the toolbar. You can choose to continue numbering (add 2, 3, 4, etc) or start multilevel numbering, which will make the next number x.1, x.2, etc..
Is there a way to merge cells in a table that I create in Doc Builder?
Yes! Refer to this Loom for instructions on how to merge and unmerge cells in a Doc Builder table.
Are there any tips or tricks you can share with me for using Doc Builder?
Yes! Click here!