STARLIMS Corporation

Laboratory Information Management Systems and Traceability of Quality Systems

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Courtesy of STARLIMS Corporation

Today’s business environment places many demands on technical managers and corporate executives. At a time when global competition forces companies to introduce products at a faster pace with higher efficiency and productivity, quality systems like ISO and Six Sigma, stipulate rigorous testing documentation. Regulatory systems, such as Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), require examination of manufacturing components—raw materials, production intermediates, and finished goods—together with meticulous records of every action and result. Customers routinely insist that manufacturers keep auditable schedules and thorough documentation as a condition of doing business.

 

These factors place strict guidelines on data management and document handling by manufacturing organizations and the testing laboratories that support them. Data archiving, retrieval, and auditing must provide traceability, accountability, and compliance with regulations. LIMS is an excellent mechanism to meet these complex data management requirements and to facilitate the move to an electronic records environment in compliance with the electronic data integrity requirements of the U.S.  FDA (21 CFR Part 11), U.S. EPA, OSHA (Occupational Safety & Health administration), and their international counterparts.

 

Traceability, accountability, and quality

Traceability is defined as “the property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties.”(1)

 

In a strict sense, traceability refers to results of measurements by scientific instruments. It is not the property of the instrument, the calibration report, or the originating laboratory. A traceable measurement is performed in a measurement system (i.e., analytical instrument) that is clearly understood and under control. Traceability implies that the instrument is subjected to a quality assurance program; is calibrated; is regularly tested against a standard reference before, during, and after sample measurement; and has established measurement uncertainty (commonly reported as variance or standard deviation) (2) for every step in the process.

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