21 CFR Part 11 Compliance with the Vi-CELL BLU Cell Viability Analyzer
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.
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.
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.
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.
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.
