Instumentation • Computing • Control


major benefits realised include improved sample turnaround times, centralised access to data and improved operational efficiencies (Fig. 2). Te system also meets the laboratory’s need for GLP and ISO17025 compliance (see below). Te solution has been capable of handling standard and non-routine sampling requirements, providing audit trails to track deviations and amendments to each study. Te 2005 release of ISO 17025, General


Requirements for the Competence of Testing and Calibration Laboratories, covers laboratories using standard, non-standard and laboratory- developed methods. Tis international standard is the accepted standard for analytical laboratories developing their data management system for quality, administrative and technical operations. Tere are several critical areas of compliance for any oil and gas operation, including security, instrumentation calibration, maintenance of electronic records, traceability of procedures and personnel and environmental and equipment monitoring. Te ability of laboratory managers at Sakhalin Energy to have control of this vital information is an important aspect of the oil and gas operation and ensures that production can continue uninterrupted by changes related to environment, personnel, instrumentation or equipment that falls out of calibration or becomes damaged in the production process. SampleManager LIMS offers a centralised system to access data and extract information, enabling effective management of laboratory operations. It provides evidence and documentation to support laboratory compliance with ISO 17025, while addressing the security required for laboratories conducting testing in their “permanent facilities, at sites away from permanent facilities, or in associated temporary or mobile facilities,” by providing full security controls, including “group security,” which can be used to segregate work from different clients or in different laboratory areas. According to Termo Scientific,


SampleManager’s enhanced functionality covers a broad range of requirements, including validation of methods, instrument calibration, sampling, control of non-conformancetesting and reporting of results. To meet ISO 17025 requirements regarding


the ‘control of non-conforming testing and/or calibration work’ the LIMS has built-in functionality for incident management and statistical analysis of both calibration standards and sample results. SampleManager also automatically maintains all electronic records and makes them available for either reviewing or reporting, and has built-in archiving, which allows for the removal of older records once their retention period has expired.


Full audit trail facilities are standard, allowing full traceability of the personnel and the procedures that were entered. Tese built-in capabilities allow laboratories to more easily review their quality system by having ready access to all incidents, corrective actions, non-conforming results and other events. To address the technical requirements of the


standard, the LIMS has built-in functionality to handle environmental monitoring, a critical component of laboratory compliance with ISO 17025. Within the LIMS, environmental monitoring of key areas of the laboratory can be scheduled on a routine basis. Certain instrumentation can be connected via SampleManager’s Instrument Manager function, and data can be collected and logged at periodic intervals. Validation of methods is a critical ISO 17025 requirement, for which SampleManager has built-in functionality to allow lab managers to be in continuous compliance. Meanwhile its Batch Management functionality provides analytical QA/QC support, including automatic and interactive sample assignment according to pre-defined templates.


Equipment and instrument calibration, also an important part of ISO 17025, is managed by SampleManager through Instrument Calibration Scheduling, allowing the LIMS to prevent the use of any instrument that is past its calibration due date. It also provides reporting that indicates which instruments are out of compliance or need calibration. Finally, to comply with ISO 17025 reporting


requirements, SampleManager’s existing functionality includes flexible report writing, making it possible to create any report format required by the laboratory, and including any data stored within the SampleManager database. l


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Fig. 2. Benefits include improved sample turnaround times, centralised access to data and improved operational efficiencies.


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