Nowadays, an analytical instrument should provide more than just accurate results: it should also ensure data security and optimize workflows. With the LabX PC software, the Excellence density meters can perform complex workflows smoothly and seamlessly. The software automatically stores results and enables users to manage large amounts of data effectively and with full traceability. Furthermore, LabX® assists you with full compliance with regulatory standards, including FDA 21 CFR Part 11.
Image Credit: Mettler-Toledo International Inc.
LabX Software - A Professional Compliance Solution
LabX is a unified software platform designed to manage all your METTLER TOLEDO instruments, together with the data they produce. With full on-screen user guidance, this easy-to-use software package increases productivity in the laboratory while facilitating regulatory compliance. Designed to meet the needs of the smallest company through to the largest global enterprise, LabX incorporates a wide range of features covering your most advanced applications, and can be integrated seamlessly into lab systems (ELNs, LIMS, or ERPs).
LabX PC software offers all the support to fulfill regulation and data integrity requirements, ensuring traceability and data integrity according to the ALCOA+ framework throughout the workflow. The audit trail and electronic signature features are at hand to enable efficient compliance with regulations such as 21 CFR Part 11.
Benefits at a glance
• Streamlined Workflows: Eliminate inefficient manual steps through centralized, automated electronic data capture. This reduces transcription errors and accelerates analysis and decision-making.
• Data Integrity and Enhanced Compliance: Ensure adherence to ALCOA++ and regulations such as 21 CFR Part 11 with robust audit trails, secure data storage, and comprehensive user authentication. All data is transmitted and stored electronically for maximum traceability
• Reduced Costs: Save money through: faster batch releases; minimized process deviations; and fewer errors - all enabled by automated workflows and consistent data handling.
• Improved Accessibility: Access instrument data, maintenance statuses, and the results of experiments in real-time - from anywhere - via a unified digital platform that supports secure remote collaboration.
Image Credit: Mettler-Toledo International Inc.
How LabX Supports Data Integrity According to FDA 21 CFR Part 11
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
No system, software, or process is compliant with such regulations per se. Compliance requires technical controls provided by instrument and software features and specific behaviors on the part of operators (in other words, procedural and administrative controls). This includes operator training and verification. Software and hardware can support correct usage. The better such technical controls are, the lower the risk of incompliant behavior on the part of instrument users.
PC Software offers an efficient way to implement technical controls to enforce compliance. Such software must have user management to make records attributable. It must also offer the ability to sign records and generate a comprehensive audit trail that cannot be edited, deleted, or deactivated. For example, instrument software should prevent the creation of invalid results, by disallowing the use of a system that is not ready (e.g., one that is overdue for calibration). It should also prohibit record deletion, even if the result is useless because of a measurement error.
To support 21 CFR Part 11 compliance, the METTLER TOLEDO LabX PC software solution offers features such as:
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User management – both centralized and available on instruments
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Electronic signatures – sign and release methods, results, and other objects
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Comprehensive audit trails – all actions performed on the instrument or PC are logged in an audit trail
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Instrument status monitoring – prevention of invalid results, as tasks can only be started on calibrated, tested, and ready-to-use instruments
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Electronic data management – secure backup of complete and traceable data
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Easy records access – to support audit-readiness and fast response times
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Workflow support – to ensure users follow the required working steps with user guidance on the instrument display
This information has been sourced, reviewed, and adapted from materials provided by Mettler-Toledo International Inc.
For more information on this source, please visit Mettler-Toledo International Inc.