S100 Supported
Neutro BCMS S100
The server side of the CFR models — users, records, audit trail.
Compliance position
21 CFR Part 11 · EU GMP Annex 11
Overview
Server software for user management, sampling records and audit trail.
Neutro BCMS S100 is the server application that CFR-model samplers report into. It holds the user directory, receives and stores sampling records, and maintains the audit trail that a reviewer works from. Records cannot be overwritten, and every action against them is logged with the user, the timestamp and the old and new value.
Features
What the model gives you
- User, role and privilege management
- Immutable audit trail with old-value / new-value capture
- Sampling record storage with no-overwrite architecture
- Electronic signature on review and approval
- Report generation and export
- Backup and restore
Applications
Where it is used
Our pharmaceutical instrument range is supplied commercially through partner brands. Neutron designs, develops and supports the technology behind it.
- Centralised environmental monitoring data management
- Paperless EM programmes
- Multi-instrument sites
- Audit trail review workflows