21 CFR Part 11
Buxco's BioSystem XA software is designed to support GLP protocols. All modern versions offer these important features:
- Locked data tables
- Login security
- Software lock-down
- Multiple levels of permissions
- Customizable security policies
- Audit trails
- Digital signatures
Each version passes extensive testing prior to commercial release. Official GLP versions (normally the first new major release) pass a much more extensive testing and documentation regimen. The resulting documentation is offered for sale to facilitate and expedite validation efforts. The documentation package includes:
- Buxco software development SOPs
- A list of GLP features
- Software regression tests
- One software analyzer set validation package, choice of:
- Pulmonary analyzers
- Cardiovascular analyzers
- Pulmonary maneuvers analyzers
Buxco also offers:
- Extended warranties and service contracts
- Documented installation, inspection, and training services
- Hardware calibration certificates
- Test signal files
- On-site signal collection services