# ELN for Production

## Overview

Production environments demand rigorous documentation practices with strict adherence to standard operating procedures (SOPs), structured workflows, and comprehensive compliance requirements. The [ELN for Production](https://www.labii.com/products/electronic-lab-notebook-eln-for-production) application provides a specialized electronic lab notebook designed for manufacturing, quality control, and production laboratory settings where standardized experiment documentation is essential for regulatory compliance and operational excellence.

By structuring experiments into organized [Sections](https://docs.labii.com/user-guide/detail-view/sections), the ELN for Production enables scientists to efficiently capture all necessary details while following standardized procedures. The application guides users through structured workflows—from sample preparation and equipment scheduling to procedure execution, result documentation, and electronic signatures—ensuring that every production experiment meets industry standards including GMP, GLP, and FDA 21 CFR Part 11 compliance requirements.

<figure><img src="https://www.labii.com/media/labii-eln-sections.webp" alt="ELN for Production showing structured sections for experiment documentation"><figcaption><p>ELN for Production organizes experiments into structured sections for efficient, compliant documentation</p></figcaption></figure>

{% embed url="<https://youtu.be/h5yxWfkZj6I>" %}

{% hint style="info" %}
The ELN for Production is ideal for regulated environments requiring structured documentation, standardized procedures, and comprehensive audit trails for quality assurance and regulatory inspections.
{% endhint %}

## Use Cases

### Pharmaceutical Manufacturing

* Document batch production experiments following GMP requirements
* Execute and record validated analytical methods
* Track raw material usage and lot numbers
* Maintain complete batch records for regulatory submissions
* Support FDA inspections with comprehensive audit trails

### Biopharmaceutical Production

* Document cell culture production runs
* Record bioreactor operations and parameters
* Track biologics manufacturing processes
* Maintain compliance with regulatory guidelines
* Document purification and formulation procedures

### Quality Control Laboratories

* Execute standardized testing protocols
* Document routine analytical testing procedures
* Record method validation experiments
* Track out-of-specification (OOS) investigations
* Maintain equipment qualification records

### Chemical Manufacturing

* Document chemical synthesis in production scale
* Record process development experiments
* Track scale-up procedures and parameters
* Maintain safety-critical documentation
* Support process validation activities

### Food and Beverage Testing

* Document product testing procedures
* Execute standardized quality control tests
* Record shelf-life stability studies
* Track compliance with food safety regulations
* Maintain HACCP-compliant documentation

### Medical Device Manufacturing

* Document production verification experiments
* Record design validation testing
* Track manufacturing process validations
* Maintain compliance with ISO 13485
* Support regulatory submissions and audits

## Getting Started

{% stepper %}
{% step %}
Navigate to **Settings → Applications** from the main menu
{% endstep %}

{% step %}
Click **Add application** and select **Add from a template**
{% endstep %}

{% step %}
Choose **Electronic Lab Notebook (ELN) for Production** from the template list

{% hint style="warning" %}
If this option is not available, the application is already installed in your account.
{% endhint %}
{% endstep %}

{% step %}
Wait for the installation to complete. The system will automatically create:

* **experiment** table for structured production experiments
* **protocol** table for standard operating procedures
  {% endstep %}

{% step %}
Access the newly created tables from the side menu to begin documenting production experiments
{% endstep %}
{% endstepper %}

## Application Structure

### Experiment Table

The **experiment** table is designed for documenting production experiments with structured workflows and standardized sections.

**Purpose**: Record production experiments following established SOPs with comprehensive documentation

**Key Columns**:

* **Account**: Links the experiment to a specific customer or internal account
* **Order**: Associates the experiment with a specific order or work request
* **Date Start**: Experiment start date (required)
* **Date Due**: Expected completion date for planning and scheduling
* **Signature Status**: Tracks signature workflow (Unsigned, Signed, Witnessed)

**Key Sections**:

* **Experiment Workflow**: Interactive guide for completing production experiments step-by-step
* **Experiment Overview**: Summary and purpose of the experiment
* **Samples**: Sample inventory and consumption tracking
* **Equipment**: Equipment used and scheduling information
* **Procedure**: Step-by-step protocol execution
* **Results**: Structured result documentation

**Typical Use**: GMP batch records, quality control testing, process validation, manufacturing experiments

### Protocol Table

The **protocol** table manages standard operating procedures and validated methods.

**Purpose**: Create and maintain standardized procedures for production experiments

**Key Columns**:

* **status**: Tracks protocol lifecycle (Drafting, Pending Review, Finalized, Archived)

**Key Sections**:

* **Steps**: Structured widget for sequential protocol instructions
* **Steps (Text)**: Rich text editor for detailed procedural descriptions
* **Documents (Attached Files)**: Supporting documentation including SDSs, specifications, and references

**Typical Use**: Standard operating procedures, analytical methods, manufacturing procedures, test protocols

## Creating a New Production Experiment

{% stepper %}
{% step %}
Navigate to the **experiment** table from the side menu or search for "experiment"
{% endstep %}

{% step %}
Click the **+ Add** button at the top of the table list view
{% endstep %}

{% step %}
Fill in the required experiment details:

* **Name**: Descriptive experiment title (e.g., "Batch 2024-001 Manufacturing Run")
* **Date Start**: Experiment start date (required)
* **Date Due**: Expected completion date
* **Account**: Customer or internal account (if applicable)
* **Order**: Associated order number (if applicable)
* **Project**: Link to relevant project
  {% endstep %}

{% step %}
Click **Save** to create the experiment. The detail view opens with the Experiment Workflow section visible
{% endstep %}

{% step %}
Follow the guided workflow to complete your production experiment systematically
{% endstep %}
{% endstepper %}

## Following the Production Experiment Workflow

The Experiment Workflow section provides a structured, step-by-step guide for completing production experiments efficiently and compliantly.

<figure><img src="https://3607108856-files.gitbook.io/~/files/v0/b/gitbook-x-prod.appspot.com/o/spaces%2F-LHVg57XIRcjV-Vbubtn%2Fuploads%2Fgit-blob-9b6afb95d360501b22e055a9401567487d051203%2Felectronic-labi-notebook-production-workflow.webp?alt=media" alt="Production experiment workflow showing sequential steps from sample preparation to signature"><figcaption><p>The experiment workflow guides users through each stage of production documentation</p></figcaption></figure>

### Step 1: Provide Experiment Overview

{% stepper %}
{% step %}
In the **Experiment Workflow** section, click **Open Overview** to access the overview section
{% endstep %}

{% step %}
Document the experiment purpose, scope, and any special considerations
{% endstep %}

{% step %}
Include references to relevant SOPs, protocols, or specifications
{% endstep %}

{% step %}
Return to the workflow section to proceed to the next step
{% endstep %}
{% endstepper %}

### Step 2: Add Samples and Reagents

{% stepper %}
{% step %}
Click **Open Samples** in the experiment workflow to access the Samples section
{% endstep %}

{% step %}
Click **Scan** to add samples by scanning barcodes or QR codes
{% endstep %}

{% step %}
Alternatively, manually add samples by selecting them from your inventory
{% endstep %}

{% step %}
Specify the quantity used for each sample. Labii automatically records consumption and updates inventory
{% endstep %}

{% step %}
Verify all required samples and reagents are documented before proceeding
{% endstep %}
{% endstepper %}

{% hint style="success" %}
Using barcode scanning for sample addition ensures accurate traceability and automatically tracks lot numbers, expiration dates, and consumption quantities.
{% endhint %}

### Step 3: Add and Schedule Equipment

{% stepper %}
{% step %}
In the workflow section, click **Open Equipment** to access equipment documentation
{% endstep %}

{% step %}
Scan equipment barcodes or select equipment from your equipment inventory
{% endstep %}

{% step %}
Schedule equipment usage by specifying the time slot required
{% endstep %}

{% step %}
Verify equipment calibration status and qualification records
{% endstep %}

{% step %}
Document any equipment settings or parameters relevant to the experiment
{% endstep %}
{% endstepper %}

### Step 4: Load or Create Procedure Steps

{% stepper %}
{% step %}
Click **Open Procedure** in the experiment workflow
{% endstep %}

{% step %}
Click **Actions → Load data from section** to import steps from an existing protocol
{% endstep %}

{% step %}
Select the appropriate SOP or protocol from the protocol table
{% endstep %}

{% step %}
The procedure steps will populate automatically in the Procedure section
{% endstep %}

{% step %}
If creating a new procedure, manually add steps using the Steps widget or rich text editor
{% endstep %}
{% endstepper %}

{% hint style="info" %}
Loading procedures from validated protocols ensures consistency and compliance across production experiments while saving documentation time.
{% endhint %}

### Step 5: Execute the Experiment

{% stepper %}
{% step %}
Follow each step outlined in the Procedure section sequentially
{% endstep %}

{% step %}
Check off steps as completed or add execution timestamps as required
{% endstep %}

{% step %}
Document any deviations from the procedure in real-time
{% endstep %}

{% step %}
Record in-process observations and measurements
{% endstep %}

{% step %}
Add photos or attachments of critical observations using the camera or file upload functions
{% endstep %}
{% endstepper %}

### Step 6: Document Results

{% stepper %}
{% step %}
Click **Open Results** or navigate to the Results section
{% endstep %}

{% step %}
Add appropriate result widgets based on your data type:

* Use **Table** widget for tabular data
* Use **Rich Text** widget for narrative results
* Use **Chart** widget for graphical data visualization
* Use **File** widget for instrument data files
  {% endstep %}

{% step %}
Enter all experimental results, measurements, and observations
{% endstep %}

{% step %}
Include acceptance criteria and pass/fail determinations
{% endstep %}

{% step %}
Attach supporting data files, chromatograms, spectra, or images
{% endstep %}
{% endstepper %}

### Step 7: Review and Sign the Experiment

{% stepper %}
{% step %}
Review all sections of the experiment for completeness and accuracy
{% endstep %}

{% step %}
Click **Open Signatures Section** in the workflow or navigate to the **Signers** tab
{% endstep %}

{% step %}
Add any required co-signers (reviewers or witnesses) before signing
{% endstep %}

{% step %}
Click **Sign** to electronically sign the experiment
{% endstep %}

{% step %}
Enter your password to authenticate your signature
{% endstep %}

{% step %}
Co-signers receive notifications and can review and sign the experiment
{% endstep %}
{% endstepper %}

{% hint style="warning" %}
Once signed, the experiment becomes locked and cannot be edited. Ensure all documentation is complete and accurate before signing.
{% endhint %}

## Creating and Managing Production Protocols

{% stepper %}
{% step %}
Navigate to the **protocol** table from the side menu
{% endstep %}

{% step %}
Click **+ Add** to create a new protocol
{% endstep %}

{% step %}
Fill in the protocol details:

* **Name**: Clear protocol title (e.g., "SOP-QC-001: HPLC Analysis Method")
* **Status**: Set to "Drafting" for new protocols
* **Description**: Brief purpose and scope of the protocol
  {% endstep %}

{% step %}
Add protocol steps using the **Steps** section for structured instructions:

* Number each step sequentially
* Include clear, actionable instructions
* Specify critical parameters and acceptance criteria
* Add safety warnings where appropriate
  {% endstep %}

{% step %}
Alternatively, use the **Steps (Text)** section for narrative-style protocols with the rich text editor
{% endstep %}

{% step %}
Attach supporting documents in the **Documents** section:

* Equipment operating manuals
* Safety data sheets (SDS)
* Validation reports
* Method specifications
* Reference standards certificates
  {% endstep %}

{% step %}
Update the **Status** as the protocol progresses through review and approval:

* **Drafting**: Under development
* **Pending Review**: Ready for quality assurance review
* **Finalized**: Approved and validated for use
* **Archived**: Superseded or retired protocols
  {% endstep %}
  {% endstepper %}

## Working with Structured Sections

The ELN for Production organizes experiments into logical sections, making it easy to locate specific data without reviewing the entire record.

### Adding Sections to Experiments

{% stepper %}
{% step %}
Open an experiment in detail view and click on the **Sections** tab
{% endstep %}

{% step %}
Click **+ Add Section** to add a new section widget
{% endstep %}

{% step %}
Select the appropriate widget type from the widget gallery:

* **Rich Text**: For narrative documentation
* **Table**: For structured data entry
* **Steps**: For procedural checklists
* **Files**: For attachments and documents
* **Images**: For photos and diagrams
  {% endstep %}

{% step %}
Configure the section name and settings
{% endstep %}

{% step %}
Click **Save** to add the section to your experiment
{% endstep %}
{% endstepper %}

For comprehensive information about working with sections, see [Sections](https://docs.labii.com/user-guide/detail-view/sections).

### Organizing Section Order

{% stepper %}
{% step %}
In the Sections tab, click the **Organize** button
{% endstep %}

{% step %}
Drag and drop sections to reorder them logically
{% endstep %}

{% step %}
Click **Save** to apply the new section order
{% endstep %}
{% endstepper %}

## Electronic Signatures for Production Records

Electronic signatures certify the accuracy and completeness of production records, ensuring regulatory compliance and creating legally defensible documentation.

### Understanding Signature Requirements

By signing a production experiment, you are certifying that:

* The documented procedures were followed accurately
* The recorded data is complete and accurate to the best of your knowledge
* The experiment meets all applicable quality standards
* The record satisfies regulatory requirements such as FDA 21 CFR Part 11
* The documentation can support audits, inspections, and legal proceedings

### Signing a Production Experiment

{% stepper %}
{% step %}
Complete all required sections of the experiment
{% endstep %}

{% step %}
Review the entire experiment for accuracy and completeness
{% endstep %}

{% step %}
Navigate to the **Signers** tab at the top of the detail view
{% endstep %}

{% step %}
If required, click **Add Co-Signer** and select reviewers or witnesses who must also sign
{% endstep %}

{% step %}
Click **Sign** to add your electronic signature
{% endstep %}

{% step %}
Enter your password to authenticate your signature. This creates a legally binding signature
{% endstep %}

{% step %}
Co-signers receive email notifications and can review and sign the experiment through the link provided
{% endstep %}
{% endstepper %}

{% hint style="info" %}
Co-signers can include quality assurance reviewers, supervisors, or witnesses required by your quality system.
{% endhint %}

For detailed information about the signature process, see [Signers](https://docs.labii.com/user-guide/detail-view/signers).

## Maintaining Complete Audit Trails

Labii automatically maintains comprehensive audit trails for all production experiments, satisfying regulatory requirements for data integrity and traceability.

### Version Control

Every change to an experiment creates a new version:

* Review complete change history with before/after comparisons
* Identify who made changes and when
* Restore previous versions if needed
* Demonstrate data integrity during audits

Access version history in the [Versions](https://docs.labii.com/user-guide/detail-view/versions) tab.

### Activity Logging

The Activities log captures all actions:

* Record creation and modifications
* Section additions, edits, and deletions
* Column value changes
* Signature and witness events
* File attachments and removals
* Status changes

View the activity log in the [Activities](https://docs.labii.com/user-guide/detail-view/activities) tab.

### Access Tracking

The Visitors log records all access to experiments:

* View timestamp for each user access
* Identify who has reviewed records
* Demonstrate access control for compliance
* Support audit trail requirements

Check access history in the [Visitors](https://docs.labii.com/user-guide/detail-view/visitors) tab.

{% hint style="success" %}
These comprehensive audit trails satisfy GMP, GLP, and FDA 21 CFR Part 11 requirements for electronic records, providing complete traceability for regulatory inspections.
{% endhint %}

## Managing Experiments in List View

The table list view provides powerful tools for managing production experiments efficiently.

### Viewing and Filtering

* Search experiments by name, account, order, or content
* Apply filters to show specific subsets (e.g., unsigned experiments, specific date ranges)
* Sort by columns such as start date, due date, or signature status
* Switch between list, grid, and calendar views
* Save custom views for frequently used filters

### Bulk Operations

* Select multiple experiments using checkboxes
* Apply bulk actions such as:
  * Adding tags for categorization
  * Exporting to PDF or Excel
  * Moving to different projects
  * Updating column values across multiple records
  * Archiving completed experiments

For comprehensive information about list view features, see [list view documentation](https://docs.labii.com/user-guide/list-view).

## Printing and Exporting Production Records

{% stepper %}
{% step %}
Open the experiment in detail view
{% endstep %}

{% step %}
Click the **More** menu (three dots) at the top right
{% endstep %}

{% step %}
Select **Print** from the dropdown menu
{% endstep %}

{% step %}
Review the print preview showing all sections, signatures, and audit information
{% endstep %}

{% step %}
Choose to print to paper or save as PDF for archival, regulatory submissions, or distribution
{% endstep %}
{% endstepper %}

{% hint style="info" %}
PDF exports include all sections, electronic signatures, and audit trail information, creating a complete record suitable for regulatory submissions.
{% endhint %}

Learn more about printing options at [Print](https://docs.labii.com/user-guide/detail-view#print).

## Advanced Features

### Linking Experiments and Protocols

Create connections between related experiments and reference protocols:

{% stepper %}
{% step %}
Open an experiment in detail view
{% endstep %}

{% step %}
Add a Rich Text or Table section widget
{% endstep %}

{% step %}
Use the insert link function to reference related protocols, previous experiments, or specifications
{% endstep %}

{% step %}
Users can click these links to navigate directly to referenced records, creating an interconnected documentation system
{% endstep %}
{% endstepper %}

### Creating Experiment Templates

Standardize recurring experiment types with templates:

{% stepper %}
{% step %}
Create an experiment with your desired structure (sections, columns, standard content)
{% endstep %}

{% step %}
Complete all standard sections and formatting
{% endstep %}

{% step %}
In the list view, select the experiment and click **Duplicate**
{% endstep %}

{% step %}
Use the duplicated experiment as a template for similar production runs
{% endstep %}
{% endstepper %}

{% hint style="success" %}
Templates ensure consistency across production batches and reduce documentation time while maintaining compliance.
{% endhint %}

### Loading Data from Previous Experiments

Reuse data from previous experiments:

{% stepper %}
{% step %}
Open the target experiment and navigate to the desired section
{% endstep %}

{% step %}
Click **Actions → Load data from section**
{% endstep %}

{% step %}
Select a previous experiment to copy data from
{% endstep %}

{% step %}
Choose the specific section to import
{% endstep %}

{% step %}
The data populates automatically, maintaining traceability to the source
{% endstep %}
{% endstepper %}

## Related Documentation

* [Electronic Lab Notebook Overview](https://docs.labii.com/applications/electronic-lab-notebook)
* [Sections and Section Widgets](https://docs.labii.com/user-guide/detail-view/sections)
* [Electronic Signatures and Signers](https://docs.labii.com/user-guide/detail-view/signers)
* [Versions and Change History](https://docs.labii.com/user-guide/detail-view/versions)
* [Activity Log](https://docs.labii.com/user-guide/detail-view/activities)
* [Visitor Tracking](https://docs.labii.com/user-guide/detail-view/visitors)
* [Detail View Features](https://docs.labii.com/user-guide/detail-view)
* [List View Management](https://docs.labii.com/user-guide/list-view)
* [Sample Management](https://docs.labii.com/applications/inventory-management/sample-management)
* [Equipment Management](https://docs.labii.com/applications/electronic-lab-notebook/broken-reference)
* [Print and Export Options](https://docs.labii.com/user-guide/detail-view#print)

***

The [ELN for Production](https://www.labii.com/products/electronic-lab-notebook-eln-for-production) application provides a comprehensive solution for scientists working in regulated production environments. With structured workflows, standardized documentation, comprehensive audit trails, and electronic signature capabilities, the application ensures that production experiments meet strict SOP requirements and regulatory standards including GMP, GLP, and FDA 21 CFR Part 11 compliance, while optimizing efficiency and data integrity in pharmaceutical, biopharmaceutical, chemical manufacturing, and quality control laboratories.