Model: NXperience & NXperience Trust
NXperience Trust FDA 21 CFR Part 11 Validation Software
NXperience Trust is NOVUS’s validated software solution developed strictly in accordance with FDA 21 CFR Part 11 and cGMP computer system validation standards. Designed for pharmaceutical manufacturers, biotechnology labs, and hospital facilities, it manages configuration, encrypted data offload, audit trails, and reporting from LogBox, FieldLogger, and DigiRail IoT instruments without allowing data alteration.
Key Features
- Full compliance with FDA 21 CFR Part 11 and Good Manufacturing Practice (cGMP)
- Tamper-proof electronic records with 256-bit proprietary cryptographic validation
- Multi-level electronic signatures and role-based user access controls with password ageing
- Comprehensive audit trail logging every configuration change, data download, and login attempt
- Automated PDF and CSV analytical reports with mean kinetic temperature (MKT) calculations
- Validation protocols (IQ/OQ/PQ) and execution packages available for pharmaceutical audits
Technical Specifications
Compliance & Security Capabilities
Connectivity & Analytics
Inquire About NXperience & NXperience Trust
Need pricing, validation documentation (IQ/OQ), or custom application sizing? Contact our bioprocess engineering team.
Applications
- Vaccine, API, and bioproduct warehouse temperature mapping and validation
- Lyophilization cycle electronic batch records (EBR)
- Cleanroom stability chambers and incubator audit compliance
Calibration & Validation
ISO/IEC 17025 factory calibration certificates and IQ/OQ documentation packages are available on request.
Include in enquiryDocumentation
Technical datasheets and user manuals are available from our engineering team upon request.
Request DocumentationRelated Products
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