In recent years, the Food and Drug Administration (FDA) and other regulators have increasingly observed Current Good Manufacturing Practice (CGMP) violations involving data integrity during inspections. These have led to numerous regulatory actions, including warning letters for violations or non-compliance.
Data integrity requirements can be fulfilled with METTLER TOLEDO’s LabX® laboratory system which is able to connect a variety of laboratory instruments and meets all requirements regarding 21 CFR 11, EU Annex 11 and ISO 17025.
LabX software comprises several modules designed to accompany METTLER TOLEDO instrumentation, such as precision and analytical balances, density meters, refractometers, auto-titrators, Karl Fisher titrators, melting point instruments, Quantos dosing systems, pH meters and UV/VIS (Ultraviolet-Visible Spectroscopy) systems, and offers complete instrument control, user friendly data management (network, processing and reporting capabilities), and integration into LIMS.
LabX thus allows the user to fully control measurements from anywhere in the laboratory or office. LabX brings power to the laboratory bench with automatic data handling, high process security and full SOP user guidance. To ensure data integrity with LabX in the laboratory, controls can be put into place so that SOPs are followed according to ALCOA (Attributable, Legible, Contemporaneous/Complete, Original, Accurate) guidelines. Automatic data transfer ensures all sample information entered travels along with the sample, from one instrument to another, eliminating any calculation and transcription errors.
In order to save space and to promote ease of use, LabX® software connected via ethernet provides flexible SOP user guidance directly on the instrument’s touchscreen and allows one to easily perform tasks and locally manage application methods, connected instruments, products and user rights, without the need for a computer next to the instrument. Individual process applications can be implemented in LabX and provide full workflow coverage (enforced guided SOPs) directly on the instrument, significantly reducing training requirements and increasing data consistency.
Auditors focus on the raw data and the metadata and the electronic records are the primary interest. With the powerful search capability, relevant data can be easily retrieved from the secure database and presented to an auditor where necessary. Data of results, measurements, tests, audit trail entries and metadata are saved, and the necessary documentation of a fully controlled and accurate process is readily available. Data integrity throughout the whole SOP process is thus simplified and achieved with LabX.
If data integrity is important to your company, then contact Microsep for your free consultation and demonstration.
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