Data Integrity and 21 CFR Part 11 Compliance

  • Digitized test reports are transferred automatically from instrument to database for the secure electronic signature process.
  • Complete audit trail for all changes to users, permissions, and protocols; archived test results cannot be altered or deleted.
  • Harmonize password expirations across an entire fleet of Hanson instruments.
  • Reduce out of specification (OOS) results while enhancing data integrity.​

in-software compliance document
 
Manage All Instruments and Dissolution Protocols In One Desktop View


screenshot of protocol management software
 

Networked Productivity

  • Centralized management of users, groups, protocols, instruments, and security settings
  • Automatically detect all instrument components and performance characteristics.
  • Quickly drag-and-drop users, protocols, and methods to specific instruments.
  • Convenient wizards help build complicated protocols; any conflicts are rapidly resolved through illustrated, context-sensitive help.
  • Scalable from single local workstation to enterprise-wide across multiple lab sites​

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diagram multiple users connecting to same instruments

​Prerequisites​​​
.NET Framework 4.5.2 or newer​ (Server and Client) ​
SQL Server 2016 or newer
​PostScript to PDF Conversion

Server Requirements
Memory
​Minimum 8 GB
Recommended 16 GB ​
Processor
​Minimum 1.7 GHz
Recommended: 4.10 GHz, with at least 6 cores
Hard disk
​At least 30 GB 
​Operating system
​Windows 10, Windows Server 2008 or newer
​​Client Prerequisites​
Memory
​Minimum 4 GB
Recommended: 8 GB or more
Processor
​Minimum 1.7 GHz
Recommended: 4.10 GHz, with at least 6 cores
Hard disk
​At least 10 GB
​​Operating system
​Windows 10 or newer