PyroButton-SQL/V for Optimal Validation Management
of Temperature and/or Temperature/Humidity
Introduction
PyroButton-SQL/V integrates Self-powered data-logger measurements with SQL database, application modules, and Decision Support Sub-system. The product is suitable for the validation management of incubators, refrigerators, freezers, warehouses, processing & laboratory facilities. Other PyroButton-SQL programs can be upgraded with EQUAL validation models.
The benefits of a single integrated solution include:
- Consistent validation process across the enterprise
- Integration & comparative analysis of the validated objects
- Consistent quality management relative to validation requirements
- Consistent Performance Qualification & re-qualification
- Scalable and modular implementation
- Effective & efficient OOS, OOT, & CAPA compliance
- Highest Return-On-Investment
The following application modules are included in PyroButton-SQL/V: Equipment, Clean Room, Facilities, Process, Container/Closure, & EQUAL Validation models.
PyroButton-SQL/V is the only out-of-the-box solution product that encompasses Self-powered data-logger operations, SQL based information management, and EQUAL Validation models for the temperature and/or temperature/humidity Validation, Validation Maintenance, Qualification, & Re-Qualification of incubators, refrigerators, freezers, warehouses, processing, & quality control facilities.
Key Benefits to the User
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Validation plan can be defined relative to:
- Design Qualification
- Performance Qualification
- Temperature specification
- % RH specification
- Load quantity requirements
- SOP
- Challenge studies (e.g., power failure, opening/closing of doors, etc.)
- Temperature Sensor Pattern Analysis
- Validation maintenance support
- Re-qualification (scheduled & unscheduled) support
- Heat distribution mapping
- OOS, OOT, & CAPA investigations relative to validation data
System Requirements
- Pentium compatible 500 MHz
- 64 MB RAM (128 MB recommended)
- CD drive for installation
- Mouse
- 800x600 display resolution, 256 color (1024x768 resolution with High Color is recommended)
- 100 MB free hard disk space
- Windows 2000 or XP operating system
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