Starting point
The laboratory ran Molecular Devices SoftMax Pro V7.2 and LabWare LIMS V8 side by side. FACS/iQue, ACL TOP and Atellica COAG 360 / CN-6000 also produced results that moved manually or via drop files.
That breaks ALCOA+: not complete, not contemporaneous, hard to reconstruct. For QC and data integrity the client needed a controlled middleware layer between vendor software and LIMS.
Approach
cube one developed middleware connecting SoftMax Pro, LabWare LIMS and additional instruments. Architecture, validation and operations were delivered end to end.
Architecture and validation
- Architecture designed; system validated on the IT side (IQ) and documented.
- Communication interface to technical stakeholders established.
- Dedicated permissions, backup and monitoring concept implemented.
Validation: computer system validation.
Instrument connectivity and operations
- Connected flow cytometry and haemostasis analysers to the application.
- Mapped result objects, error handling and audit trail of transfer.
- Delivered feature requests; system operation under GxP change on SoftMax and LIMS side.
Operations: IT administration. Related: Chromeleon administration.
Outcome
Data integrity and system validation
- System meets all data-integrity requirements.
- SoftMax Pro and LIMS connected; additional instruments linked to the application.
- Data protected from loss; system successfully validated.
Automated QC data flow
- QC results flow automatically into LIMS.
- Features successfully implemented; operation assured.
- Bridge as controlled GAMP 5 Category 5 layer between vendor software and LIMS.
We use a similar pattern in central Chromeleon administration. Vendor sites: SoftMax Pro, LabWare.