Ingenix Software Validation Documents

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

Qualification Documents
Item No.: 
DSX-PC01LH-SVM01

*Custom/bulk order quotes are provided within 24 hours of request.

The Ingenix® Suite Software Qualification Documents are designed to support lab compliance by ensuring that the installation and operation adhere to the highest regulatory standards. These documents are tailored to specific software modules, providing a comprehensive solution for maintaining compliance and efficiency.

Digital Document Access: Access the document templates online for a rapid start, ensuring a seamless and efficient process. This feature allows labs to obtain the necessary documentation, minimizing delays and facilitating immediate compliance efforts quickly and easily.

Customized Documentation: The documentation is tailored to specific software modules, ensuring that all necessary details are included.

By leveraging the Ingenix® Suite Software Qualification Documents, labs can ensure that their software modules are installed and operated according to the highest standards, maintaining compliance with regulatory requirements. This documentation solution supports labs in achieving streamlined processes and minimizing the complexities associated with compliance management.

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

  • Application
    Pipette check validation

Features

  • Device/Instrument Compatibility
    Cubis® II MCA

Product Information

  • License
    n/a
  • Qualification Documents
    Pipette Check OQ
  • Ingenix Balance Fleet Management Software

    Top Features of Ingenix Suite Balance Fleet Manager Module

    • Unlimited Cubis® II MCA balance connections
    • Remote update of Cubis® II MCA firmware and QApp center
    • Automated digital weighing data transfer
    • 1 Balance license included

    Popular Applications for Ingenix Suite Balance Fleet Manager Module

    • Fleet management
    • Lab weighing
    • Digital data management

  • Ingenix Pipette Advanced Calibration
    Item no.
    DSX5PC01LWGADC01

    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

  • Ingenix Balance Fleet Management Software

    Top Features of Ingenix Suite Balance Fleet Manager Module

    • Unlimited Cubis® II MCA balance connections
    • Remote update of Cubis® II MCA firmware and QApp center
    • Automated digital weighing data transfer
    • 1 Balance license included

    Popular Applications for Ingenix Suite Balance Fleet Manager Module

    • Fleet management
    • Lab weighing
    • Digital data management

  • 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

  • Ingenix Balance External Calibration Software Module

    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

  • 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

  • Ingenix Pipette Advanced Calibration
    Item no.
    DSX1PC01LWGADC01

    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

  • Ingenix Balance External Calibration Software Module

    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

  • Ingenix® Suite Installation, Qualification & Training Service

    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

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