Thermo Fisher Scientific Demonstrates new SampleManager LIMS Functionality for ISO 17025 at Analytica 2008
MUNICH, Germany, (April 1, 2008) – Thermo Fisher Scientific Inc., the world leader in serving science, will introduce new functionality to its flagship Thermo Scientific SampleManager LIMS that facilitates industrial laboratory compliance with the requirements of ISO 17025: 2005. This new LIMS functionality will be showcased at the Thermo Scientific booth 105/204, Hall B1 at Analytica 2008, being held in Munich, Germany, from April 1-4.
The 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. This international standard is the accepted standard for analytical laboratories developing their data management system for quality, administrative and technical operations. SampleManager LIMS offers a centralized system to access data and extract information, enabling effective management of laboratory operations. SampleManager LIMS provides evidence and documentation to support laboratory compliance with ISO 17025.
To respond to the Management Requirements of ISO 17025, SampleManager addresses 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. SampleManager’s enhanced functionality covers a broad range of requirements, including validation of methods, instrument calibration, sampling, control of non-conformance testing and reporting of results.
To meet ISO 17025 requirements regarding the “control of non-conforming testing and/or calibration work”, SampleManager 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 for SampleManager, allowing full traceability of the personnel and the procedures that were entered. These 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, SampleManager has built-in functionality to handle environmental monitoring, a critical component of laboratory compliance with ISO 17025. Within SampleManager, 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. SampleManager’s 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 ISO17025, 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. SampleManager 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 a powerful and flexible report writing, making it possible to create any report format required by the laboratory, and including any data stored within the SampleManager database.
For more information about Thermo Scientific informatics solutions, please visit the Thermo Scientific booth 105/204, Hall B1 at Analytica 2008. Alternatively, please call +49-6103-408-0, e-mail marketing.informatics@thermofisher.com or visit www.thermo.com/informatics.
Thermo Scientific is part of Thermo Fisher Scientific, the world leader in serving science.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $10 billion, we have more than 30,000 employees and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. Serving customers through two premier brands, Thermo Scientific and Fisher Scientific, we help solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education. Together, we offer the most convenient purchasing options to customers and continuously advance our technologies to accelerate the pace of scientific discovery, enhance value for customers and fuel growth for shareholders and employees alike. Visit www.thermofisher.com.
