PHARMA FOCUS // LAB EQUIPMENT & SERVICES
LabX software for data integrity in pharma labs
Data integrity is a critical component of pharmaceutical product quality and the information submitted to regulatory agencies. However, in recent years an increasing number of inspections have revealed incomplete data, a lack of audit trails and falsification of results.
Did you know? Mettler Toledo’s LabX is not just a connection to an instrument, it is a complete laboratory solution. With LabX there is no need for PCs in the laboratory as the system works remotely via the network. It automates all administrative work, making paperless lab a reality.
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n July 2014, the United States Food and Drug Administration (FDA) issued a stern warning that data integrity was a key focus of its enforcement efforts. The UK Medicines and Healthcare Products Agency (MHRA) went further and issued GMP data integrity definitions and guidance for industry in January 2015. As regulators continue to tighten their inspection approaches, it is critical for managers and scientists in regulated GXP (good practice) laboratories to understand key issues surrounding data integrity and to be able to demonstrate compliance.
MULTIPLE INSTRUMENTS, ONE SOFTWARE Mettler Toledo’s powerful LabX laboratory software connects to a variety of laboratory instruments and meets all data integrity criteria and requirements regarding 21 CFR 11, EU Annex 11 and ISO 17025. LabX software, available locally from Microsep, comprises several modules designed to accompany Mettler Toledo instrumentation, such as precision and analytical balances, density meters, refractometers, autotitrators, Karl Fisher
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titrators, melting point instruments, Quantos dosing systems, pH meters and ultravioletvisible spectroscopy systems.
STREAMLINE PROCESSES With LabX, you have complete instrument control, electronic data management (network, processing and reporting capabilities), and seamless integration of laboratory systems into LIMS to cover complete workflows. Via a single software interface, you can centrally manage instruments, resources, SOPs, tasks and users. This results in the smooth operation of laboratory systems and significantly reduces the effort for validation, maintenance and support.
INCREASE WORKFLOW EFFICIENCY LabX automates multiple-parameter workflows to increase throughput and reduce cost per sample. Automatic data transfer ensures all sample information entered travels along with the sample, from one instrument to another, eliminating any calculation and transcription errors. Ensure traceability and data integrity throughout the workflow. Controls can be put into
Above: LabX software fully networks your main laboratory instruments to ensure seamless operations and efficient workflows Right: LabX software interface allows one to centrally manage instruments, resources, SOPs, tasks and users
place so that SOPs are followed according to the ALCOA+ framework – attributable, legible, contemporaneous/complete, original and accurate.
EASY COMPLIANCE Access your data quickly and easily during an audit. With the powerful search capability, relevant data can be easily retrieved from the secure database. 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. •
Microsep – www.microsep.co.za
