2.1 Common Document Features – 1factory, Inc.

All QMS document types share core functionality that ensures consistent document control, compliance tracking, and quality management across your organization.

2.1.1 Creating Documents

The document creation process follows a consistent pattern across all document types, with minor variations in required fields.

Step 1: Navigate to Document Type

All document types are accessed through the QMS Documents tile: QMS Tab > QMS Documents tile > select the appropriate tab (QMS Standards, Mfg. Standards, Procedures, Work Instructions, Forms)

Step 2: Create New Document

Click the appropriate New [Document Type] button to initiate the document creation process.

Step 3: Define Document Properties

Configure the required fields based on your document type:

Common Fields (All Document Types):

Document No/Document No Prefix: Select or confirm the document numbering format
Title: Enter a descriptive title for your document
Business Function: Choose from the dropdown (must match LOV)
Owner: Assign the QMS role responsible for this document
Sub-type: Optional. Select from your organization's configured List of Values to classify the document. Sub-type can be assigned or changed while a document is in Draft status and all changes are tracked in the document's audit history.

Document-Specific Fields:

Standards Additional Fields:
- Standard Number: Standard number used within organization
- Standard Revision: The revision of this document and is free text
- Issuing Org: Choose the standards organization from dropdown
Forms Additional Fields:
- Upload: To upload the template file for this Form
- Record Number Prefix: Required if creating Records from this Form
Work Instructions Additional Fields:
- Part Number: Optional. Select a Part Master if this Work Instruction is specific to a particular part number. This association is set at creation and cannot be changed afterward.

After completing all required fields, click the Save button to begin creating the document body content.

2.1.2 Editing Documents

Once your document is created, you can draft and refine content using 1factory's built-in rich-text editor. This editing environment provides the tools needed to create clear, compliant documentation that meets ISO standards and regulatory requirements.

Core Editing Features

Rich-Text Formatting: Style content using bold, italic, underline, text color, and highlighting directly in the editor toolbar. No special syntax or markdown is required.Simply just use the tool bar at the top of each content section.
Structural Formatting: Organize content using bullet lists, numbered lists, and indentation controls.
Tables: Insert tables directly into any section and manipulate rows and columns as needed. When exporting to PDF, tables are appended to a Table Glossary at the end of the document, with inline links from each section pointing to the corresponding table in the glossary.
Images and Video: Insert media by clicking the image icon in the toolbar, by dragging and dropping a file directly into a section, or by pasting an image from your clipboard.
Cross-References: Type a document number (for example, PRO-1 or WI-4) anywhere in the document body. When viewed in Reading Mode, correctly entered document numbers automatically become clickable hyperlinks to the referenced document.
Section Management: Add, modify, or delete sections using the Add New Section Before, Add New Section After, Section Number and Heading, Inline Section, and Delete Section controls.
Mode Switching: Toggle between Editing Mode, Reading Mode, and Redline Mode.
Auto-Save: All changes are automatically saved to prevent data loss.

Step 1: Use 1factory Built-in Editor

Begin drafting your document with headings and content. During your document drafting process, use 1factory's built-in editor to help you create documents quicker. This is particularly valuable when documenting complex requirements that require precise step-by-step instructions and clear formatting.

External Document ONLY: Content appears in the window on the right side of the interface, with form preview on the left. The right hand content field is typically used to reference other QMS documents in the system to the form itself.

Step 2: Switch Between Editing Modes

1factory provides three viewing modes to support different stages of document development:

Editing Mode: Allows you to edit and draft the content of the document. Access by default when creating new documents. Use when drafting new content or making revisions.
Reading Mode: Displays document in read-only format as it appears to end users. Hyperlinks become active and clickable. Use to review document flow and verify cross-references. Important: Document numbers must be typed correctly. In Reading Mode, correctly linked documents appear blue and underlined. Incorrect references appear in red and black.
Redline Mode: View content changes highlighted in different colors. Green indicates additions or modifications compared to the previous revision. Essential for maintaining compliance with quality management standards. Provides clear documentation of modifications between versions.

Step 3: Section Modification

Within Editing Mode, use these features to structure your document:

Add New Section Before: Inserts an empty section before the current section. Useful when adding preliminary instructions or safety warnings.
Add New Section After: Inserts an empty section after the current section. Ideal for adding clarifications that follow the current content.
Section Number and Heading: Creates a section with both a number and heading. Ensures consistent formatting throughout documentation and makes it easier for users to navigate complex procedures.
Inline Section: Creates inline content without a formal heading. Useful for adding supporting information, notes, or brief clarifications.
Delete Section: Removes the current section. A warning message appears before deletion. Note: Deleted content cannot be recovered after confirmation.

Note: Deleted content cannot be recovered after confirmation

Step 4: Insert Images and Videos

Visual aids are crucial for process instructions, showing equipment setup, safety procedures, or quality checkpoints.

To Insert:

Click the Image icon in the top menu bar
Click the Paper Clip icon to select your file, then choose a placement option.
Place Image At Right (default) wraps text around the image.
Place Image At Bottom positions the image at full width below the text.

To Delete:

Select the image or video.
Click the Delete icon in the top menu.

Image Annotation for Document Drafting

The Image Annotation feature allows users to insert images and add annotations directly onto uploaded images during the document drafting process. This supports comprehensive quality management documentation by enabling users to mark up, highlight, and annotate visual content within controlled documents.

After you insert an image into your document, navigate to the Markup Image icon to annotate your image. This feature is located in the top menu where the Add Image and Video features are found. Click on your image and navigate to the Markup Image button.

1factory offers 5 annotation tools: Select, Arrow, Rectangle, Circle, and Line, combined with 6 colors (Red, Orange, Yellow, Green, Blue, Black) to help you mark up your document. With each annotation you insert, you can change size, move, rotate, and specify the color. Click the (X) icon in the top right corner of the toolbar to cancel an annotation.

Forms: Unlike other document types, Forms do not support native rich-text content authoring. Instead, the controlled document is an uploaded file. In Editing Mode, click the Upload Form Document icon, click the paper clip icon to select your file, and click Go. Supported file types include PDF, Word (.doc, .docx), Excel (.xls, .xlsx, .xlsm), and PowerPoint (.ppt, .pptx, .ppsx). Uploaded PDFs display in read-only mode within 1factory. All other file types appear as a downloadable link. To replace the file with a newer version, simply upload a new file following the same steps.

2.1.3 Related Documentation

The Related Documentation feature creates a comprehensive network of cross-referenced documents, making it easier for operators and auditors to navigate between related documents.

Step 1: Input documents into content

Place the reference document number and into your document body during drafting.

Step 2: Activate the hyperlink

Switch between Edit Mode and Reading Mode to activate the hyperlink. The document number will become blue and underlined when correctly linked.

Note: If you input the wrong document number, the hyperlink cannot be activated.

Step 3: View related documents

Click the Related button on the left menu bar to view all documents linked to the current document.

The Related Documentation feature creates a comprehensive network of cross-referenced documents, making it easier for operators and auditors to navigate between related documents.

2.1.4 Assigning Training

Not Available For: Record Types

The Training feature ensures personnel receive proper instruction before executing quality processes. Training records are maintained automatically, providing audit trails for regulatory requirements.

Step 1: Assign the training

On the left vertical menu, click the Training tile to start assigning training for users.

Step 2: Configure training parameters

Select Roles: Choose which QMS roles require training
Time to Complete: Set deadline for training completion after document release
Retraining Interval: Define automatic retraining schedules if document isn't revised within time frame
Assessment Method: Select Self Assessment, Quiz, or External Certificate

After completing all fields, click the Go button.

Step 3: Design Quiz training (if applicable) If using Quiz assessment:

Click the Quiz tile on left vertical menu
Design questions and answers for the training
Click Go button after completing all questions

2.1.5 Assigning Document Approvers

Define the approval workflow before documents become active in the QMS, ensuring proper review and authorization.

Step 1: Assign Approvers

On the left vertical menu, click the Approvers tile.

Step 2: Select approver roles

Choose QMS roles required to approve the document
System automatically includes mandatory approver role from organization settings
After completing selections, click Go button

Note: If your document requires more than two roles with multiple approvers, select a different approver name for each role.

2.1.6 Document Access Control

Configure viewing permissions based on roles and responsibilities, ensuring only authorized personnel can access documents.

Step 1: Initialize Access Controls

On the left vertical menu, click the Access tile.

Step 2: Configure Access Restrictions

Viewer Roles: Define which QMS roles can view the document
Applicable Organizations: For Federated QMS, specify which organizations can access documents

After completing selections, click the Go button.

2.1.7 Document Attachments

Not Available For: Record Types

Attach supporting files to provide additional resources and reference materials.

Step 1: Attach document

Click the Attach tile on the left vertical menu.

Step 2: Select and manage files

Click paper clip icon to add files
Use Shift + left click for multiple files
Click (x) icon to remove files
Click (x) at Manage Attachments to exit

Supported capabilities:

Various file formats (PDF, Word, Excel, images)
Version control for attached files
Attachments inherit parent document access controls
Full audit trail of attachment changes

2.1.8 Document History

Provides a complete audit trail of all changes and activities, maintaining compliance with regulatory requirements.

Access by clicking the History icon on left menu bar to view:

Revision history with all document versions
User activity tracking
Status change log
Approval records and comments
Training assignment history
Access logs
Upload/Download activity (Record Types only)

2.1.9 Routing Documents for Approval

Manage the document lifecycle from creation to release through proper workflow management.

Step 1: Access Management

Click the Manage tile on the left vertical menu.

Step 2: Route for Approval

Select the Approver(s) from the dropdown menu, click the Pending Approval button to start the approval process, and click Save. The approver receives an email notification.

Step 3: Approve or Reject the Document

Each assigned approver navigates to the document, opens the Manage tab, and selects either Approved or Rejected. An optional approval note can be entered to provide context for the decision. Click Save to record the decision.

If the document is rejected, the document author receives an email notification. The author can then either return the document to Draft status to make the requested changes and re-route for approval, or discuss the reason for rejection directly with the approver before taking further action. Once any changes are made in Draft, the document must be re-routed through the full approval process.

Step 4: Release Document

Once all required approvers have approved the document, return to the Manage tab. If Document Effectivity is enabled in QMS Settings, you will see a Pending Release option between Approved and Released. See Section 2.1.10 for details on that workflow. Otherwise, switch the status from Approved to Released, add Release Notes (required), and click Save.

Minor Update Process

For released documents requiring minor edits without full approval, open the document and click Manage, click Draft to create a new revision, make edits in the new revision, return to Manage and select Yes for Minor Update, select AMENDED status, add Release Notes (required), and click Save.

Note: Minor updates use a decimal revision format (for example, A becomes A.1). Minor updates can be completed by any user holding the Mandatory Approver Role.

Multi-Stage Approval with Mandatory Approver Controls

For organizations that require stricter approval sequencing, 1factory supports a multi-stage approval workflow through the Mandatory Approver Controls Release setting. This setting is available in QMS Settings when a Mandatory Approver Role is configured. All behaviors described below are only active when this setting is enabled.

When a document is moved to Pending Approval, the Mandatory Approver is set to Pending while all other approvers are set to a Waiting status. Waiting approvers receive no notification and cannot submit an approval decision until the Mandatory Approver has approved the document.

Once the Mandatory Approver approves, all remaining approvers are advanced to Pending and receive their email notifications. If the Mandatory Approver rejects the document, all other approvers remain in Waiting status and the document must be returned to Draft before it can be re-routed.

After the Mandatory Approver signs off, the document content and all Manage tab settings become read-only. The only actions available at that point are approval decisions for users with a Pending approval and release authority for users in the Mandatory Approver Role. Only users assigned to the Mandatory Approver Role can transition the document from Approved to Released. Release notes are mandatory when this setting is enabled.

Note: If the Mandatory Approver Role is changed in settings while a document is actively in the approval process and the new role does not appear in the document's approver list, the system reverts to standard behavior and all approvers proceed to Pending simultaneously.

2.1.10 Tasks & Approvals

When a document is routed for approval, responsibility for moving it forward is distributed across multiple approvers, sometimes across multiple roles and organizations. Without a centralized view, quality managers are left chasing status updates individually or building manual reports in Excel. The Tasks & Approvals tile on the QMS tab provides a live, exportable reporting surface for all open and completed approval activity across documents, plans, and records.

Accessing Tasks & Approvals

Navigate to the QMS tab and click the Tasks & Approvals tile. The tile displays two counts: open Tasks and pending Approvals for the current user. Clicking either count opens the Tasks & Approvals page pre-filtered to that type and scoped to the logged-in user.

The page has two tabs: Tasks and Approvals. A dropdown controls the scope of whichever tab is active:

My Tasks & Approvals (default): scoped to the logged-in user
All Tasks & Approvals: unfiltered view across all users and roles

The Tasks Tab

The Tasks tab displays all open quality action items assigned to you or your roles across the system. Each row shows the task ID, Description, the Source record it originated from (such as NCR-252978 or CAPA-871), the Context within that record, who Created the task, who it is Assigned To, the associated Role, the Due Date, any Resolution notes, and the current Status.

Status values are color coded for quick scanning:

Open: Task is active and assigned
Unassigned: Task exists but has not yet been assigned to a specific user
Closed: Task has been completed and resolved

Due dates flagged with a warning icon indicate the task is past due.

Clicking anywhere on a task row opens the originating record directly in a new window, so you can act on it without losing your place in the list.

The Approvals Tab

The Approvals tab provides a structured list of all approval requests across QMS documents, plans, and records. Each row represents one assigned approver on one object revision, giving managers full visibility into who is pending, who has approved, and where bottlenecks exist.

The following columns are available:

Name: The document reference number and title, plan part master and description, or record identifier. Clicking the name opens the object in a new window.
Revision: The revision or version the approval is for. Color coded to reflect current status, consistent with the document and plan list views. Filterable by status.
Type: The type of object the approval is for: QMS Document, Plan, or Record. Filterable.
Sub-Type: For QMS Documents only. Displays the document type (Procedure, Standard, Work Instruction, etc.) combined with any customer-defined Sub-Type configured in your List of Values. Filterable.
Approver: The username of the assigned approver. Filterable.
Role: The QMS role associated with the approval, where applicable. Plan approvals do not use roles. Filterable.
Days Open: The number of days from when the approval was placed into Pending status to either the current date (if still open) or the date the approval was closed (if approved or rejected).
Last Activity: The date of the most recent status change, including when the approval was made pending, approved, or rejected. Filterable by Today or Past Week, supporting daily status reporting without manual comparison.
Status: Color coded and filterable. Values are:
- Assigned: Pending, assigned to the current logged-in user
- Pending: Pending, assigned to another user
- Approved
- Rejected

Federated QMS Visibility

For organizations operating a Federated QMS, the Approvals tab shows approvals for all documents owned by the current organization. Users in the parent organization have visibility across all child organizations, supporting cross-org approval monitoring without requiring a separate login or report.

Exporting the List

Both the Tasks and Approvals lists can be exported to Excel using the Excel button in the command bar. The export respects any filters currently applied, allowing quality managers to generate targeted reports by status, approver, object type, or date range for audit preparation, KPI reviews, or daily standup reporting.

2.1.11 Document Effectivity

Optional Feature: Document Effectivity is disabled by default. To enable it, navigate to QMS Settings and set Documents are Immediately Effective to No. See Section 1.2 for configuration details.

In most manufacturing environments, releasing a revised procedure and training personnel on it happen simultaneously. For organizations operating under FDA 21 CFR Part 820 or ISO 13485, that is not enough. Auditors require documented evidence that personnel completed training before a procedure became active in production. Without a formal separation between "released for training" and "effective in production," organizations are left managing that gap with external spreadsheets, disconnected audit trails, and manual coordination.

Document Effectivity closes that gap. When enabled, a Pending Release status is introduced between Approved and Released. During Pending Release, the document is distributed to assigned personnel for training, carries a visible PENDING - UNRELEASED watermark in-app and on printed copies, and is not accessible to general users through the standard Released document view. On a defined Effective Date, and once any configured training threshold has been met, the document automatically transitions to Released. The full sequence is documented and timestamped, providing auditors with a complete chain of evidence.

Step 1: Move the Document to Pending Release

Once all required approvers have approved the document, return to the Manage tab. With Document Effectivity enabled, a Pending Release status will appear between Approved and Released in the versioning control.

Select Pending Release and set the Effective Date. The Effective Date defaults to the current date plus the Time to Complete value from the document's training plan. If no training plan is configured, it defaults to the current date. The date must be set to the current date or a future date.

If eSignatures are enabled for your organization, you will be required to complete the release eSignature before saving. If Mandatory Approver Controls Release is enabled, only users assigned to the Mandatory Approver Role can move a document to Pending Release.

Helper text below the Effective Date field describes exactly when and how the document will be released based on your current settings. This text updates dynamically as you change the date or threshold values.

Step 2: Personnel Complete Training

Once the document enters Pending Release, training assignments are automatically generated for all roles defined in the document's training plan, and notification emails are sent. Personnel access the document from their My Training list. The document is clearly marked as not yet released.

Step 3: Automatic Release

The system checks training completion every time a user completes training on the document, and also checks all Pending Release documents hourly against their Effective Date. As soon as both conditions are met, the document is automatically moved to Released, stakeholders are notified, and the Effective Date is recorded as the actual release date.

If the training threshold is met but the Effective Date has not yet arrived, the document remains in Pending Release until the date passes. If the Effective Date passes but the threshold has not been met, the document remains in Pending Release and the Effective Date column turns red to signal the overdue status.

Note: Once a document is Released, its status will not revert even if training completion subsequently drops below the threshold, for example if additional ad-hoc training is added after release.

Using Effective Date Only (No Training Threshold)

Organizations that want to schedule a future release date without gating on training completion can set the Training Completion Threshold to 0 in QMS Settings. With a threshold of 0, the document moves automatically from Pending Release to Released on the Effective Date regardless of training status. This allows quality teams to pre-schedule document releases for planned change events, product launches, or scheduled procedure updates while still maintaining a formal, auditable effective date in the system.

Manual Override by Mandatory Approver

A user assigned to the Mandatory Approver Role can release the document manually at any time, bypassing the Effective Date and training threshold. To do this, open the Manage tab while the document is in Pending Release and change the status to Released. If eSignatures are enabled, the approver must complete a signature attesting to the override. Release notes are required and must include a justification for bypassing the standard release conditions.

The Mandatory Approver can also change the Effective Date while a document is in Pending Release, provided the new date is the current date or a future date. If the training threshold has already been met and the Effective Date is changed to the current date, the document immediately moves to Released. A confirmation modal will appear before the change is saved.

A document can also be returned from Pending Release back to Approved (or Draft, if no approvals are configured), which cancels all training generated for the pending release. This action requires a release note justification and an eSignature if enabled.

Minor Revisions and Effectivity

Minor revisions skip the Pending Release status entirely and are always immediately released. The Effective Date for a minor revision is automatically set to the date of release. The Manage tab dynamically adjusts available status options based on whether a revision is marked as Minor Update.

2.1.12 External/Legacy Files

Not Available For: Standards (uses PDF Reference Document instead)

When "Allow external files as documents" is enabled, use existing PDFs or Office documents as controlled versions.

Step 1: Upload PDF file

In Editing Mode, click PDF icon
Click Upload Document icon
Select file using paper clip icon
Click Go button

Step 2: Review uploaded content

PDFs display in read-only mode
Word documents appear as downloadable links
Switch between PDF review and Edit in 1Factory as needed

2.1.13 Document Import Options

1factory offers two methods to import existing content into your QMS documents.

Option 1: Automated Document Import

Transfer content from Word, PDF, or .txt files while preserving formatting.

Step 1: Open Import feature

Click the Import tile on the left vertical menu.

Step 2: Copy and paste content

Copy content from source file
Paste into Import Content field
Select format option:
- Inline: For continuous text
- Number & Heading: For structured sections
Choose action:
- REPLACE: Overwrites existing content
- ADD: Inserts at current position
Click Go button

Option 2: Convert PDF File

Transform complete PDFs into native 1factory format.

Step 1: Initiate conversion

Click the CONVERT button on the left vertical menu.

Step 2: Configure settings

Sub Section Format: Choose INLINE or NUMBER & HEADING
Image Position: Select BOTTOM or RIGHT
Click Go to process

Step 3: Verify results Switch to Edit Mode to review and compare converted content.

2.1.14 Update Reference Legacy Document

Available when "1factory with legacy numbers" is enabled. Automatically updates document number references during QMS migration.

Step 1: Enable legacy numbers

Click your name > Settings
Navigate to QMS Settings
Select "1factory with legacy numbers"
Click Save

Step 2: Update references

Open document in Draft status and Editing Mode
Click UPDATE REFS tile
Confirm update (action cannot be undone)
Legacy numbers change to 1factory numbers

2.1.15 Document PDF Export

Not Available For: Record Types (use Form Download instead)

Generate PDF versions for offline use, printing, or external distribution.

Export Process:

Click PDF tile on left vertical menu
File downloads automatically with:

Complete document content
All formatting and images preserved
Document metadata (number, revision, date)
Watermarks indicating document status