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NXperience Trust Flyer

NXperience Trust Flyer
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Inviolable information Data security More Reliability in the data record Flexibility of configuration GMP Compliance (21CFR Part 11) NXperience Trust is validating software specially designed for the pharmaceutical, food and health market segments for the configuration and data collection of data loggers for the environment variables to be monitored. networked installations, with more than one workstation and with centralized server data. These segments require a reliable, simple and intuitive system to use, as complete data analysis and visualization, user authentication, and information security features. The NXperience Trust complies with the technical requirements of FDA 21 CFR Part 11 for validation of computer systems. The user has an electronic record of encrypted data, a strong authentication mechanism with password validity, and an application event log for traceability and audit trail. The NXperience Trust connectivity allows it to be used as a central data management tool, and can handle information from all devices in Protocols and execution of validation are optional and offered separately, in order to complement the solution. DATA MANAGEMENT DEVICE DIAGNOSTICS VALIDATION FDA 21 CFR PART 11 • Controlled access to software ANALYTICAL REPORTS SETTING PARAMETERS VERIFICATION AND VALIDATION SPECIFICATION • 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 FUNCTIONAL SPECIFICATION SOFTWARE AND HARDWARE DESIGN OPERATION QUALIFICATION

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REQUIREMENTS FROM FDA 21 CFR PART 11 Secure Access Allows creating users to access software with different predefined permission levels - user profiles - to features and data. Password creation features with rules and expiration period, automatic logout of user by inactivity and user blocking by password expiration or consecutive login attempts with invalid password. DATA LOGGER Audit Trail Record of all actions performed by the user in the software, logging information such as the user identification and the action timestamp. It allows to generate track report and apply filters per user,...

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