LIMS Limitation?

Commercially available LIMS can improve basic operational laboratory efficiency through:

• Automatic allocation of tests and workflow tasks to samples at registration
• Elimination of time-consuming paperwork and other cumulative process related time savings
• Elimination of transcription errors through automatic data capture
• Automated checking of results against defined specifications or limits
• Enforcement of workflow steps such as double-blind data entry and independent verification of results
• Streamlining of final report production and delivery based on the lab’s, and the customer’s, particular needs

Many other benefits are available from a fully functioning LIMS. For example laboratory workload can be managed through calendar scheduling of testing based on resource availability. In supprt of this, a LIMS can be used to record the operational status of each piece of equipment in order to prevent work being allocated to an instrument that is out of calibration or maintenance. Such a system will also keep a history of all maintenance and calibration events for audit purposes and provide reminders of pending calibration and maintenance tasks.

Having this data available also allows the laboratory to evaluate maintenance costs and instrument reliability. Not only must instruments be available in an operational state, the staff allocated to use them must be appropriately trained. Indeed, ISO/IEC 17025 requires documentation that all staff are suitably qualified for the tasks that they undertake in terms of appropriate education, training, experience and/or demonstrated skills.

A LIMS should include functionality to record and manage personnel skills and training records. Attendance at training courses can be recorded for lab personnel and certificates of competency issued and stored to provide a historical record of skills acquired. Automatic renewal reminders can be issued for time dependent qualifications. Unqualified personnel, or personnel whose qualifications have lapsed, can be prevented from carrying out specific tasks. A LIMS can also be configured to include the costs associated with running different tests to allow the automatic generation of quotations and invoices. While there are clear benefits here for contract testing laboratories, this capability can also help ‘internal’ labs keep track of their operating costs.

A LIMS can also be used to address or support wider lab management functions, many of which are requirements for accreditation to ISO/IEC 17025:2017(E). These include:

• Control of management system documents
• Control and management of other records
• Actions to address risks and opportunities
• Quality and Management Improvement
• Corrective actions (CAPA)
• Internal audits
• Management reviews

All laboratory process and procedures should be documented and provision made for access for everyone who needs them. It is possible for LIMS to track, store and distribute all documents from a central location. Document versioning provides a full audit trail allowing the history of revised documents to be traced for internal and external auditing and reporting.

Laboratories also need to be accountable for the analytical results that they produce. ISO/IEC 17025 requires policies to be in place to deal with customer complaints, with records of any complaints and subsequent investigations undertaken and corrective actions implemented being maintained. A LIMS can also be used to document and monitor any preventive action plans that laboratories have in place to identify improvement opportunities and potential sources of nonconformities.

By providing access from a single integrated source to the type of operational and management data described above, many of the requirements of ISO/IEC 17025 can be addressed. In addition, historical data that can be of huge value to an organisation is available in the LIMS. Using statistical process control methods, it is possible to monitor the laboratory processes to reveal trends, identify areas for potential improvement and detect serious problems. The LIMS can be used to model the effect of potential business changes. For example, by using historical information on turn-around times and the number of trained analysts available, it is possible to assess the impact on the laboratory that an increased sample throughput could have.

By providing access from a single integrated source to the type of operational and management data described above, many of the requirements of ISO/IEC 17025 can be addressed. In addition, historical data that can be of huge value to an organisation is available in the LIMS.

Using statistical process control methods, it is possible to monitor the laboratory processes to reveal trends, identify areas for potential improvement and detect serious problems. The LIMS can be used to model the effect of potential business changes. For example, by using historical information on turn-around times and the number of trained analysts available, it is possible to assess the impact on the laboratory that an increased sample throughput could have.

Not everyone might be familiar with the concept of BIMS. BIMS solutions apply the information management principles used within LIMS to more general business data to provide the capability to track and manage business critical information. Autoscribe Informatics’ BIMS includes the Quality Management Suite which features modules for Competency Tracking, Asset Management, Customer Feedback, Audit Planning, Document Management and CAPA (Corrective and Preventative Action Management).

As well as being available as a stand-alone system for purely business applications, these BIMS modules integrate seamlessly into the Matrix Gemini LIMS meaning that a single system can be used to address the issues described above, and many more. Thus, for example, in addition to the traditional LIMS activities, the system can maintain records of technician certifications/training and results of performance checks, thus preventing a user without up-to-date qualifications from recording results from given samples.