Data Integrity Compliance Software for Laboratory Process Management
Is LIMS not enough?! Ensure data integrity with LabX Server, the software for process management in laboratories!
Since the FDA announced its data integrity guidance, more companies have decided on their response policies and have gradually begun to take actual action, but is their response truly sufficient? Many users have already implemented common information systems used in laboratories, such as LIMS, but the critical flaw of these systems is that they only record test reports. Unless it can be proven that the processes leading to a certain test result are complete, consistent, and accurate, data integrity cannot be achieved. Metler Toledo's "LabX Server" can integrate with LIMS and ELN, and it comprehensively manages not only sample information and test report management through higher-level systems but also the results of measurement and testing processes, each step execution results, equipment used, and whether any modifications were made. Furthermore, because it can reliably execute everything from workflow design to management, it also serves as a mistake-proofing measure in laboratory work, helping to avoid risks such as redoing tasks and wasting samples. Please take a look at the details of Metler Toledo's LabX Server, which simultaneously achieves efficiency improvement, productivity enhancement, and data integrity assurance.
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.
Delivery Time
OTHER
Model number/Brand name
LabX Server
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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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.
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