21 CFR Part 11 Compliance in Vi-CELL BLU 2.0 Cell Viability Analyzer Software
Published: August 26, 2026
Supporting GMP Compliance Through Improved Data Integrity, Traceability, and Process Controls
Key Takeaways
- Supports GMP compliance through improved user controls, workflow standardization, and SOP alignment.
- Enhances data integrity and traceability with advanced audit logging and sample management controls.
- Improves audit readiness while reducing manual effort and the risk of operator error.
In regulated biopharmaceutical and pharmaceutical laboratories, failure to adhere to Good Manufacturing Practice (GMP) requirements can lead to data integrity concerns, inconsistent processes, audit observations, increased risk of human error, and delays in product release.
To address these challenges, Vi-CELL BLU 2.0 analyzer software introduces several software enhancements designed to support GMP-compliant workflows, improve traceability, and simplify integration into existing laboratory procedures and Standard Operating Procedures (SOPs).
How Vi-CELL BLU 2.0 Analyzer Software Supports GMP Compliance
Individual Roles and Permissions
Vi-CELL BLU 2.0 analyzer software moves away from predefined user roles and enables customers to create individually tailored user roles and permissions.
Value:
- Better alignment with site-specific GMP requirements
- Improved adherence to laboratory user management policies
- Easier integration with existing SOPs and quality systems
Prevention of Duplicate Sample and Sample Set Names
Administrators (or users with appropriate permissions) can enforce unique sample names and sample set names across the system.
Value:
- Reduces the risk of accidental or intentional data duplication
- Enhances traceability of sample records
- Increases confidence during audits and regulatory inspections
Automated Quality Control Pass/Fail Assessment
Quality control results are automatically displayed in:
Green when within the ±10% specification range
Red when outside specification limits
Value:
- Reduces manual calculations and interpretation
- Minimizes risk of operator error
- Enables quicker identification of out-of-specification results
Detection of Empty Cups and Invalid Samples
A new functionality allows users to identify and flag invalid samples based on predefined criteria.
Value:
- Helps identify situations where a sample cup may be empty or otherwise unsuitable for analysis
- Improves consistency of sample handling procedures
Adjustable Concentration Display Units
The concentration results can be displayed in 10⁵ cells/mL and 10⁶ cells/mL.
Value:
- Simplifies transition between Vi-CELL XR and Vi-CELL BLU analyzers
- Reduces the need for manual data conversion
Enhanced Audit Log Functionality
Audit log records have been updated to accurately reflect all system events and improve traceability.
New audit log entries include:
- QC pass/fail events
- Low concentration warnings
- User unlock events
- Sample start events
- Sample completion events
- User attribution for system-generated actions
Value:
- Strengthens audit readiness
- Improves traceability of user and system actions
- Supports investigation of deviations and CAPAs
Pre-Dilution Added to Re-Analysis Workflow
Users can now apply a pre-dilution factor directly during sample re-analysis.
Value:
- Avoids unnecessary repeat testing when a dilution factor was omitted during initial analysis
- Reduces operator burden
Ability to Apply Run Options Across All Users
Authorized users can apply defined run options globally to all users on the system.
Value:
- Simplifies standardization of system settings
- Reduces administrative workload
- Streamlines activities such as data export settings and user-right synchronization
Supporting Data Integrity, Traceability, and Audit Readiness
Vi-CELL BLU 2.0 analyzer software introduces multiple enhancements focused on data integrity, user control, traceability, process standardization, and audit readiness.
By addressing key GMP requirements and reducing opportunities for human error, these features help laboratories build more robust quality systems, simplify compliance efforts, and integrate the analyzer more effectively into regulated manufacturing and quality control environments.
FAQ on the 21 CFR Part 11 Compliance in Vi-CELL BLU 2.0 Analyzer Software
How does duplicate sample prevention improve data integrity?
Unique sample and sample set naming requirements help reduce the risk of accidental duplication, improve traceability, and increase confidence during audits and inspections.
How do customizable user roles support regulated laboratories?
The software allows laboratories to create site-specific user roles and permissions that align with internal GMP procedures, SOPs, and quality management requirements.
What audit trail enhancements are included in Vi-CELL BLU 2.0 analyzer software?
Enhanced audit logs include quality control pass/fail events, low concentration warnings, user unlock events, sample start and completion events, and user attribution for system-generated actions.
Can Vi-CELL BLU 2.0 analyzer software help standardize workflows across users?
Yes. Authorized users can apply predefined run options across all users, helping standardize workflows, reduce administrative effort, and maintain consistent operating procedures.
How does Vi-CELL BLU 2.0 analyzer software support GMP compliance?
Vi-CELL BLU 2.0 software includes enhancements focused on user management, audit trails, data integrity, traceability, process standardization, and quality control workflows that support GMP-compliant laboratory operations.
*Product in development. Performance characteristics have not been validated.
