The specification for this system complies to the following standards
GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems.
- FDA 21 CFR Part 11.
- Validation testing – DQ, MSV, IQ, OQ.
- Microsoft Azure Cloud Platforms
- Sense Anywhere data is stored in the Azure Cloud - HyperScale Azure SQL database.
- Sense Anywhere is ISO 27001 certified.
Enterprise
Unlimited users
- Standard+Pro subscription features
- Data Storage Period 15 years
- Unlimited users
- Hierarchical divisions
Standard
10 users
- Web-based software
- Cloud-based infrastructure
- Triple redundant database
- FDA 21 CFR part 11 compliant
- Data Storage Period 5 years
- 10 users
- Scheduled reports
Pro
25 users
- Standard subscription features
- Data Storage Period 10 years
- 25 users
- Generate reports on demand
- Transport alarm: trip ok/not ok
- Scheduled alarm profiles
