Quality is such an important part of the supply chain that manufacturing companies implement information systems specifically for the laboratories that perform the quality inspections on finished goods and in-process materials.
The Laboratory Information Management System (LIMS) is an information system that can schedule testing, track tests, and pass test results to other systems in the supply chain, such as an Enterprise Resource Planning (ERP) system.
Primary Role of LIMS
The LIMS system is used primarily as a reporting tool where users can enter information about a test sample, such as the inspection number, the batch of material it was extracted from, the date, time, location etc.
The LIMS system holds the details of the sample and the information pertaining to where the sample is. As the sample moves through the testing process, the LIMS system can be updated so that users where each sample is at any time. The tracking of a sample can be performed by entering the sample number into the system and manually entering the location or by using barcodes. When a sample is initially entered into the system, the LIMS can print a barcode label with the unique sample number.
Different LIMS systems offer a variety of functionality. The systems have developed from simple data entry and record storage to complex relational database-driven tools. They now offer enhanced functionality often provided over the wireless networks and company intranet, allowing greater flexibility for inspections in remote and difficult environments.
Regulations and Compliance
The functionality of the LIMS system is far greater than just tracking and reporting on samples. LIMS systems must often comply with regulations that affect the user, for example, a manufacturer of pharmaceuticals is obliged to operate under the cGMP 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs. Other regulations that LIMS systems must operate under include HIPAA, ISO 9001, and ISO 15189.
It is important for systems to have the ability to accept e-signatures, as well as offer audit trails and chain of custody. These types of functionality are required to ensure that the correct persons have access to the sample and the results of the sample inspection.
Equipment Calibration and Maintenance
When inspections are carried out the equipment used to extract the sample and to test the sample must be maintained correctly and calibrated so that there are no errors introduced into the test results. The LIMS system should contain maintenance records of the equipment used in testing so that notifications can be generated to perform regular preventive maintenance.
With some instruments and equipment, the requirement may include calibration after a certain number of uses, for example, the use of a depth micrometer may require that it is calibrated after 50 uses or every month, whichever comes first. LIMS systems can also contain the calibration instructions so that a notification and a calibration instruction sheet can be sent to the maintenance department or a specialty outside vendor.
A LIMS system should contain and manage the process, procedures, and methodologies that can be used to perform the test required at the plant. The system should provide a single repository for these methodologies and be able to select the correct method for the tests that are to be performed.
Why LIMS Is Important
Companies require that quality is part of every link in the supply chain, whether it is raw material at a vendor’s facility or finished goods delivered to a customer. To ensure that the quality personnel are able to achieve the optimum results, a Laboratory Information Management System is vital to that success.
Optimizing your supply chain means that you are delivering your customers what they want when they want it and spending as little money as possible getting that done. A robust LIMS will help keep quality up and scrap down and drive optimization.
Updated by Gary Marion, Logistics and Supply Chain Expert.