Ingenix GxP Compliance Software Module
Top Features of GxP Compliance Module
- Supports Compliance with 21 CFR Part 11 and EU Annex 11
- electronic signatures and four-eyes principle
- Full Audit Trail of Devices and the System
- Exporting of Audit Trail
Popular Applications for GxP Compliance Module
- Audit Preparation
- Filtering audit records by user, balance name, serial number, timestamp, and more
- Reviewing, Removing, and Commenting of audit relevant events
- Quality Assurance in GxP Environments
- Item No.:
- DSX1PC01---GXP01
*Custom/bulk order quotes are provided within 24 hours of request.
Choose your Ingenix Suite - Lab Data and Fleet Management Software
The GxP Compliance Module from Ingenix® Suite is designed to ensure that laboratory operations meet the stringent requirements of Good Practice (GxP) regulations. This module provides tools to record and manage compliance-related activities and streamline workflows.
The module centralizes critical information through two robust audit systems: the Device Audit Trail and the System Audit Trail.
The Device Audit Trail maintains detailed audit records for each device, documenting actions such as reviewing and commenting on events with precise timestamps. Users can filter these audit records by timestamp, module, username, event, serial number, balance name, and device type, ensuring comprehensive and accessible data management.
The System Audit Trail captures all compliance-related activities within the Ingenix® Suite logging critical system events, user activities, and modifications to lab data. This system allows users to filter and view audit records by timestamp, module, username, and event, ensuring that all actions are meticulously tracked and can be reviewed to uphold high standards of data accuracy and reliability.
Additional features include the four-eye principle, reviewing lab data, and legally binding electronic signatures. The module supports comprehensive reporting capabilities, enabling the generation of detailed, customizable compliance reports for internal reviews or regulatory submissions. These reports provide valuable insights into compliance processes and ensure adherence to industry standards. Real-time monitoring and reporting allow for proactive management of compliance issues, ensuring that your laboratory operations always remain compliant.
Ingenix® is a powerful software suite designed to optimize and simplify data and device management. It offers tools for data analysis and reporting, ensuring high efficiency and accuracy in your lab operations. Ingenix® allows you to easily create and send diagnostic files directly to the Support Team for streamlined service processes. With advanced role management, you can customize user roles with specific access levels to match lab responsibilities. The suite supports both LDAP and local user management, fitting seamlessly into your IT infrastructure. Additionally, Ingenix® provides flexible license activation options, both online and offline, through MySartorius.com. Transform your lab with Ingenix®—where innovation meets precision.
Disclaimer: The Ingenix® Trademark is registered in the EU, CN, IL, JP, SG, CH, TR, and GB.
Applications
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ApplicationGxP compliant use of Ingenix Suite
Features
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Device/Instrument CompatibilityCubis® II MCA
Product Information
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License Period1 Year
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Qualification Documents1 Year
Top Features of Software Qualification Documents
- Digital Document Access
- Tailored Documentation to specific software modules
- Option to purchase without Service
Popular Applications for Software Qualification Documents
- Software Installation and Operational Qualification
- Regulatory Compliance Assurance
Top Features of Software Qualification Documents
- Digital Document Access
- Tailored Documentation to specific software modules
- Option to purchase without Service
Popular Applications for Software Qualification Documents
- Software Installation and Operational Qualification
- Regulatory Compliance Assurance
Top Features of Software Qualification Documents
- Digital Document Access
- Tailored Documentation to specific software modules
- Option to purchase without Service
Popular Applications for Software Qualification Documents
- Software Installation and Operational Qualification
- Regulatory Compliance Assurance
Top Features of Software Qualification Documents
- Digital Document Access
- Tailored Documentation to specific software modules
- Option to purchase without Service
Popular Applications for Software Qualification Documents
- Software Installation and Operational Qualification
- Regulatory Compliance Assurance
Top Features of Software Qualification Documents
- Digital Document Access
- Tailored Documentation to specific software modules
- Option to purchase without Service
Popular Applications for Software Qualification Documents
- Software Installation and Operational Qualification
- Regulatory Compliance Assurance
Top Features of Installation, Qualification & Training Service
- Flexible installation service
- Flexibility through additional optional services like IQ/OQ & training
Popular Applications for Installation, Qualification & Training Service
- Software Installation and Qualification
- Compliance Assurance
- User Training
Top Features of Lab Balance Device Management
- Centralized and Automated Lab Weighing Data Transfer from Cubis® II MCA Lab Balance
- Remote Firmware Update of Cubis® II MCA Lab Balance and QApps
- One Cubis® II MCA Lab Balance License included
- Possibility of unlimited Cubis® II MCA Lab Balance Connections
- Automated Balance Detection within the Network
Popular Applications for Lab Balance Device Manager Module
- Balance Device and Data Management (Optionally Working with existing LIMS/ELN Systems)
Top Features of External Balance Calibration Module
- Guided Calibration Workflow at the Cubis® II MCA Lab Balance
- Management of External Weighing Sets
- Management and Scheduling of Calibration Jobs
- Balance and Weight Set Information in Reports
- One Cubis® II MCA Lab Balance License included
Popular Applications for External Balance Calibration Module
- External Balance Calibration
- Record all Relevant Calibration Data
- Create Comprehensive and Customizable Reports for Calibration Activities
Top Features of Advanced Pipette Calibration Module
- Supports Compliance with ISO 8655:2022 and ISO/IEC 17025
- Extended Measurement Uncertainty Calculation in accordance with ISO 8655:2022 and ISO/TR 20461:2023 with the Option to include lab and operator effect
- Guided Pipette Calibration Workflow
- Includes one balance license and is compatible with all Sartorius and selected 3rd party balances
- Ability to upload Calibration and Measurement Capability (CMC) Table
Popular Applications for Advanced Pipette Calibration Module
- Routine Pipette Calibration
- Data Management
- Calibration Measurement Reporting
Top Features of Advanced Pipette Calibration Module
- Supports Compliance with ISO 8655:2022 and ISO/IEC 17025
- Extended Measurement Uncertainty Calculation in accordance with ISO 8655:2022 and ISO/TR 20461:2023 with the Option to include lab and operator effect
- Guided Pipette Calibration Workflow
- Includes one balance license and is compatible with all Sartorius and selected 3rd party balances
- Ability to upload Calibration and Measurement Capability (CMC) Table
Popular Applications for Advanced Pipette Calibration Module
- Routine Pipette Calibration
- Data Management
- Calibration Measurement Reporting
Top Features of External Balance Calibration Module
- Guided Calibration Workflow at the Cubis® II MCA Lab Balance
- Management of External Weighing Sets
- Management and Scheduling of Calibration Jobs
- Balance and Weight Set Information in Reports
- One Cubis® II MCA Lab Balance License included
Popular Applications for External Balance Calibration Module
- External Balance Calibration
- Record all Relevant Calibration Data
- Create Comprehensive and Customizable Reports for Calibration Activities
Top Features of Pipette Check Module
- Streamlined Workflow for balance-assisted pipette checks
- Management of Pipettes and Tips
- Scheduling and Management of Pipette Checks
- One Cubis® II MCA Lab Balance License included
Popular Applications for Pipette Check Module
- Routine Pipette Accuracy Checks
- Testing Precision Before Sensitive Applications
- Pipette Performance Reporting
Top Features of Pipette Check Module
- Streamlined Workflow for balance-assisted pipette checks
- Management of Pipettes and Tips
- Scheduling and Management of Pipette Checks
- One Cubis® II MCA Lab Balance License included
Popular Applications for Pipette Check Module
- Routine Pipette Accuracy Checks
- Testing Precision Before Sensitive Applications
- Pipette Performance Reporting
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