Validation software solution NXperience Trust

data analysisvisualizationquality control

NXperience Trust is a validation software designed to meet good automated manufacturing practices in Pharmaceutical and Food & Beverage processes by keeping track of configuration and data collection from data acquisition systems. These applications require a reliable, user friendly and intuitive software to guarantee data analysis and visualization, user authentication, and security features. The NXperience Trust centralizes and manages the process data and handles information from all devices in the network offering the possibility to work with more than one workstation. The NXperience Trust complies with GAMP (Good Automated Manufacturing Practices) and meets FDA 21 CFR Part 11 technical requirements for computer systems validation. Electronic records are encrypted, user access requires a strong password authentication, application event log for traceability and audit trail. Validation Protocols are optional and offered separately to complement the solution. - Device Configuration - Data Integrity and Reliability - Device Connectivity - User Control - Audit Trail - Validation FDA 21 CFR Part 11 Controlled access to software Automatic user logout Encryption of electronic data records Presentation of the data in a readable format Backup of the electronic records in the network server Detection of change of electronic records Records of occurrences (for Audit Trail) Electronically signed reports