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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.

■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.

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LabX Server

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.