Starting point
Excel-based processes for inventory control, inbound and outbound storage ran in different laboratory areas without unified validation documentation. Temperature logger data from around 100 devices was imported manually.
For QA and data integrity, audit trail, central data storage and reproducible evaluations were missing. The client needed validated ESS solutions with direct integration into validation dossiers.
Approach
cube one validated two ESS programmes in parallel: sample management and logger import with automated statistics and parameterised UI.
ESS sample management
- ESS validation in laboratory areas (inventory control, inbound/outbound).
- Implemented audit trail and AD user management.
- Migrated storage from local to central SQL Server infrastructure with integrity checks.
ESS temperature loggers
- Developed and validated ESS for automated data import from around 100 temperature loggers.
- Automatic generation of statistical evaluations and charts.
- Parameterised UI for flexible acceptance criteria and period selection.
Method: Excel sheet validation under 21 CFR Part 11.
Result
Validation documentation
- Standardisation of validation documentation for validated Excel systems.
- Significant reduction in documentation effort.
- Direct integration into validation dossiers.
Compliance and scale
- 100% regulatory compliance with FDA 21 CFR Part 11.
- Increased data security through external data storage.
- Scalability for multiple laboratory areas and staff; error sources eliminated through automation.
Related: LabWare LIMS rollout.