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Isolation Intelligent Detection System

Focuses on wireless integrity testing of gloves and RTP, improving
group control efficiency and compliance traceability.

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Wireless glove integrity testing system

Developed according to the GB/T25915.7-2010/ISO 14644-7:2004 standard, in compliance with FDA/GMP regulations and computer system validation requirements, providing reliable and efficient glove integrity testing.




Core Functionality

Comprehensive Audit Trail

Historical data, operations, alarms, formula records and user lists can all be backed up and restored
Supports adding reason records to meet compliance requirements
Audit trail records can be filtered by specific conditions for quick review of historical operations

Multi-level User Permission Management

Multi-level user permission system with customizable permission selection
Password complexity requirements: numbers, uppercase & lowercase letters, special symbols
Customizable minimum length, password lock, mandatory first-time password change, password validity period
User account activation and deactivation functions

Compliant with 21 CFR Part 11 Standards

Complete electronic signature system
Electronic record management with function to add reason notes

Power & Network Outage Data Protection

Recorded data in the tablet control software is retained after equipment power failure
Data can be restored after disconnection between equipment and tablet

Full-range Data Management

Automatic PDF report export
Dual database backup & recovery for SQLite and SQL
Supports local and off-site backup
Two backup modes: manual and automatic

Intelligent Test Program

Optional safety and pressure drop test programs
Supports custom test formulas to meet diverse scenario demands

Product features