Data Integrity Compliance Software for Laboratory Process Management

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basic information

■Ensure system security and always respond to audits Generated data, as well as metadata such as date, time, user information, and equipment status, are securely stored in a central database, covering all points of ALCOA and ALCOA+. ■Support for regulatory compliance Built-in security features such as electronic signatures, audit trails, management of measurement device inspections, and user management options help ensure compliance with regulations and maintain a state of readiness for audits. ■Efficient workflow By using LabX Server, applications can be developed, results can be automatically generated and recalculated, user guidance can be displayed on equipment, and warnings can be issued if operations are not performed according to SOPs, thereby improving efficiency and productivity in both the lab and office without compromising quality or accuracy. ■System configuration and data sharing By connecting Mettler Toledo balances, pH meters, melting point measurement devices, spectrophotometers, and titrators to LabX Server via LAN, data can be shared between devices. Additionally, data can also be automatically transferred to external systems.

Price information

The price varies depending on the type of license. Please feel free to contact us.

Applications/Examples of results

Data Acquisition: Automatically exchanges data transfer with devices. In addition to eliminating transcription errors, it removes the need for verification by another person in regulated environments. SOP Management: Real-time transmission of SOPs to appropriate devices from a central server. Ensures the use of the correct workflows and versions, as well as tracking for all balances and selected tasks of the devices. Workflow: The assignment of settings and workflows for both operators and devices can be executed directly using device software or imported from external systems. Data Security and Access Control: All data is stored on the server and is fully compliant with regulatory standards such as 21 CFR Part 11. Access control allows for the setting of permissions and authorizations regarding the execution of laboratory tasks and data access. Sample Management: Ensures traceability back to the origin of data, such as measurements taken by balances, for each sample.

Detailed information

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  Complete Lab Solution - Power Up Your Equipment with LabX! LabX Server can connect to multiple laboratory instruments from Mettler Toledo. By connecting to laboratory instruments, you can benefit from streamlined workflows, appropriate security support, and centralized management of multiple instruments, users, and data.

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  From Paper to Digital - Management of Measurement Data Accurate measurement and data integrity are essential elements in the preparation of standard solutions for analysis, dispensing of samples for analysis, and preparation of standard liquids. Errors in this process can significantly affect data integrity and product quality. By implementing software, it is possible to prevent double-checking of data and redoing work in case of mistakes.

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  Efficient Workflow Management Are you managing work procedures such as workflows and SOPs by hand? With LabX Server, you can protect processes and SOPs through workflow design, integration of workflows into devices, and warnings when operations deviate from SOPs. This feature also serves as a "poka-yoke" for lab work, contributing to improved efficiency and productivity.

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  Ensuring Security Support LabX Server is equipped with security features such as electronic signatures, audit trails, and user security. This ensures that your lab system is always ready for audits.

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  Centralized Management of Measurement and Analysis Data All measurement data, raw data, and contextual metadata collected from the devices are automatically stored in a central database. This supports operators in focusing on actual analysis efficiently by eliminating transcription errors through automatic data transfer and minimizing the time spent on management tasks with automatic report generation features.

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  Data Integrity Generated data, dates, times, user information, device status, and other metadata are securely stored in a central database. LabX Server can track data from its creation to storage. It not only manages data based on ALCOA+ principles but also retains and manages sufficient metadata.

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  System Configuration and Data Sharing The LabX Server can connect to Mettler Toledo's XPR Ultra Micro and Micro Balances, XPE Analytical Balances, Quattro Dispensing Solutions, SevenExcellence pH Meters, Excellence Automatic Melting Point Determination Devices, Spectrophotometers, and Titrators. By connecting these devices via LAN, it is also possible to share data between them. Furthermore, data can be automatically transferred to external systems.