ELN for Production
Designed to meet the unique requirements of scientists working in production environments, where strict adherence to standard operating procedures (SOP) and standardized experiment notes is necessary.
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 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, 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.
The ELN for Production is ideal for regulated environments requiring structured documentation, standardized procedures, and comprehensive audit trails for quality assurance and regulatory inspections.
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
Navigate to Settings → Applications from the main menu
Click Add application and select Add from a template
Choose Electronic Lab Notebook (ELN) for Production from the template list
If this option is not available, the application is already installed in your account.
Wait for the installation to complete. The system will automatically create:
experiment table for structured production experiments
protocol table for standard operating procedures
Access the newly created tables from the side menu to begin documenting production experiments
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
Navigate to the experiment table from the side menu or search for "experiment"
Click the + Add button at the top of the table list view
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
Click Save to create the experiment. The detail view opens with the Experiment Workflow section visible
Follow the guided workflow to complete your production experiment systematically
Following the Production Experiment Workflow
The Experiment Workflow section provides a structured, step-by-step guide for completing production experiments efficiently and compliantly.
Step 1: Provide Experiment Overview
In the Experiment Workflow section, click Open Overview to access the overview section
Document the experiment purpose, scope, and any special considerations
Include references to relevant SOPs, protocols, or specifications
Return to the workflow section to proceed to the next step
Step 2: Add Samples and Reagents
Click Open Samples in the experiment workflow to access the Samples section
Click Scan to add samples by scanning barcodes or QR codes
Alternatively, manually add samples by selecting them from your inventory
Specify the quantity used for each sample. Labii automatically records consumption and updates inventory
Verify all required samples and reagents are documented before proceeding
Using barcode scanning for sample addition ensures accurate traceability and automatically tracks lot numbers, expiration dates, and consumption quantities.
Step 3: Add and Schedule Equipment
In the workflow section, click Open Equipment to access equipment documentation
Scan equipment barcodes or select equipment from your equipment inventory
Schedule equipment usage by specifying the time slot required
Verify equipment calibration status and qualification records
Document any equipment settings or parameters relevant to the experiment
Step 4: Load or Create Procedure Steps
Click Open Procedure in the experiment workflow
Click Actions → Load data from section to import steps from an existing protocol
Select the appropriate SOP or protocol from the protocol table
The procedure steps will populate automatically in the Procedure section
If creating a new procedure, manually add steps using the Steps widget or rich text editor
Loading procedures from validated protocols ensures consistency and compliance across production experiments while saving documentation time.
Step 5: Execute the Experiment
Follow each step outlined in the Procedure section sequentially
Check off steps as completed or add execution timestamps as required
Document any deviations from the procedure in real-time
Record in-process observations and measurements
Add photos or attachments of critical observations using the camera or file upload functions
Step 6: Document Results
Click Open Results or navigate to the Results section
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
Enter all experimental results, measurements, and observations
Include acceptance criteria and pass/fail determinations
Attach supporting data files, chromatograms, spectra, or images
Step 7: Review and Sign the Experiment
Review all sections of the experiment for completeness and accuracy
Click Open Signatures Section in the workflow or navigate to the Signers tab
Add any required co-signers (reviewers or witnesses) before signing
Click Sign to electronically sign the experiment
Enter your password to authenticate your signature
Co-signers receive notifications and can review and sign the experiment
Once signed, the experiment becomes locked and cannot be edited. Ensure all documentation is complete and accurate before signing.
Creating and Managing Production Protocols
Navigate to the protocol table from the side menu
Click + Add to create a new protocol
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
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
Alternatively, use the Steps (Text) section for narrative-style protocols with the rich text editor
Attach supporting documents in the Documents section:
Equipment operating manuals
Safety data sheets (SDS)
Validation reports
Method specifications
Reference standards certificates
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
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
Open an experiment in detail view and click on the Sections tab
Click + Add Section to add a new section widget
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
Configure the section name and settings
Click Save to add the section to your experiment
For comprehensive information about working with sections, see Sections.
Organizing Section Order
In the Sections tab, click the Organize button
Drag and drop sections to reorder them logically
Click Save to apply the new section order
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
Complete all required sections of the experiment
Review the entire experiment for accuracy and completeness
Navigate to the Signers tab at the top of the detail view
If required, click Add Co-Signer and select reviewers or witnesses who must also sign
Click Sign to add your electronic signature
Enter your password to authenticate your signature. This creates a legally binding signature
Co-signers receive email notifications and can review and sign the experiment through the link provided
Co-signers can include quality assurance reviewers, supervisors, or witnesses required by your quality system.
For detailed information about the signature process, see 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 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 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 tab.
These comprehensive audit trails satisfy GMP, GLP, and FDA 21 CFR Part 11 requirements for electronic records, providing complete traceability for regulatory inspections.
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.
Printing and Exporting Production Records
Open the experiment in detail view
Click the More menu (three dots) at the top right
Select Print from the dropdown menu
Review the print preview showing all sections, signatures, and audit information
Choose to print to paper or save as PDF for archival, regulatory submissions, or distribution
PDF exports include all sections, electronic signatures, and audit trail information, creating a complete record suitable for regulatory submissions.
Learn more about printing options at Print.
Advanced Features
Linking Experiments and Protocols
Create connections between related experiments and reference protocols:
Open an experiment in detail view
Add a Rich Text or Table section widget
Use the insert link function to reference related protocols, previous experiments, or specifications
Users can click these links to navigate directly to referenced records, creating an interconnected documentation system
Creating Experiment Templates
Standardize recurring experiment types with templates:
Create an experiment with your desired structure (sections, columns, standard content)
Complete all standard sections and formatting
In the list view, select the experiment and click Duplicate
Use the duplicated experiment as a template for similar production runs
Templates ensure consistency across production batches and reduce documentation time while maintaining compliance.
Loading Data from Previous Experiments
Reuse data from previous experiments:
Open the target experiment and navigate to the desired section
Click Actions → Load data from section
Select a previous experiment to copy data from
Choose the specific section to import
The data populates automatically, maintaining traceability to the source
Related Documentation
Equipment Management
The 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.
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