What is ISO/IEC 17025?
ISO/IEC 17025 is a company-level accreditation based on the "General requirements for the competence of testing and calibration laboratories" standard released by the International Organization for Standardization (ISO). The latest edition of this standard is ISO/IEC 17025:2005. ISO/IEC 17025 is a general umbrella name used to refer to the specific standard. The standard is divided into two sections: management requirements (which are largely concerned with the operation and effectiveness of the laboratory's quality management system) and technical requirements (primarily related to the competence of staff and calibration of equipment). The standard also includes quality management standards such as document control and remedial action. This standard serves as the foundation for accrediting body accreditation. This accreditation is limited to a specified scope.
What is the role of a Laboratory Information Management System (LIMS)?
The most significant job of a LIMS in a laboratory is to boost operational efficiency by automating and streamlining operations, removing the need for human data entry and ensuring compliance with regulatory requirements. A good LIMS makes it simple to retain records and report on them, reducing the chance of human mistake and speeding up the overall turnaround time.
How does a LIMS work?
In a nutshell, a LIMS tracks a sample's path from the moment it enters a laboratory until the end of its life cycle, which includes the stages of Sample Storage, Testing, Reporting, and Archiving. When a sample is brought into a lab, the LIMS operation begins by registering it on the system and assigning it a unique identification number. The corresponding information can then be updated in a LIMS as the samples move through the laboratory, maintaining the audit trail.
Purposes of Laboratory Information Management System (LIMS)
As previously said, a good LIMS strikes a balance between record keeping and report generating. The following are some of the most important features of a LIMS:
Sample Management
One of the most important roles of a LIMS is sample management. A LIMS keeps thorough, accurate records of each sample and securely saves them, preventing data loss as it moves between departments. When a sample transfers from one laboratory unit to another, the Chain of Custody is updated to guarantee that the sample's location and custodian are properly tracked.
Inventory Management
LIMS' inventory management feature is an important aspect of a laboratory's day-to-day operations. A LIMS is used to keep track of stock supplies and reagents. In the event of stock depletion, a LIMS can send out automatic restock warnings. These alerts help laboratories run more smoothly and avoid any delays caused by product shortages. A LIMS can also help you store accurate and up-to-date information about your equipment, as well as alert you when it's time to replace or maintain it.
Test Management
A LIMS aids in the standardisation of testing workflows while also allowing for complete and accurate management over the testing process. A LIMS helps you to manage the tests performed on a batch of samples, as well as easy data entry, tracking approval/validation of results, and report production. Furthermore, you can manage test analytes and assign tests to certain LIMS users.
Reporting
Reporting is an important aspect of a LIMS since it allows a laboratory to get a comprehensive perspective of the data collected and potential patterns while also lowering the laboratory's reporting overhead. Sample tracking, sample summary, inventory, system configuration, test results, audit trail, QC data, sample/analysis count, invoicing, freezer space, instrument calibration, and other reports are all possible with a LIMS.
Who can use a Laboratory Information Management System (LIMS)?
There are various industries that use a Laboratory Information Management System to manage their laboratory data. Some of the major industries include:
- Clinical Research & Diagnostics- manage patient data and specimen information, maintain various test records and test results, generate reports, and automate laboratory workflows.
- Biobanks and Biorepositories- track biological samples and manage their storage locations for easy retrieval of the samples and their associated data.
- Food & Beverage Testing Laboratories- manage food and beverage samples, maintain test records, generate reports, and automate testing workflows.
- Cannabis Testing Laboratories- manages clients, test orders, cannabis samples, tests for cannabinoid and pesticide levels, terpenes, moisture, heavy metal, fungi and molds, and generates a Certificate of Analysis (COA) while complying with regulatory compliance
- Oil & Gas Testing Laboratories- manages sample batches, tests, testing schedules, sample monitoring, and review and validation of results with complete traceability for external auditing purposes.
- Agriculture Testing Laboratories- manages sample types like soil, plant tissue, seeds, insects, feed, oils, nuts, husks, flowers, and more. The laboratories maintain sample booking, tracking, testing, quality control, test report generation, facilitating growers to take decisions in the field.