As quality control (QC) is a crucial aspect of the supply chain, most manufacturers utilize a system of information for laboratories that carry out inspections on materials being processed as well as finished products. This is typically LIMS (Laboratory Information Management System), which is capable of scheduling and tracking tests, as well as relaying their results to another information system on the supply chain.

Quality Control Role

The primary role of LIMS in QC is reporting, and so it is a tool that users use for logging data regarding test samples, including its inspection number, source of batch material, the date and time performed, location of testing, etc.

LIMS contains a sample’s details as well as its present location. Throughout the process, it can be updated to allow users to track its whereabouts using a manual method or barcodes. Upon first entering a sample into LIMS, a barcode label can be printed out to assign a coded number for the sample.

Functionality

Depending on its particular type, a LIMS may offer various levels of functionality. Systems have evolved from simple data entry and storage. A modern LIMS is a very complex information system utilizing relational database-driven tools. They can now also provide functions transmitted over wireless networks and a manufacturer’s intranet, permitting QC inspections at off-site and challenging locations.

Compliance

A LIMS is required to comply with federal regulations that pertain to its user. For instance, a pharmaceutical company must comply with 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs.

Equipment Standards

Equipment utilized for sample extraction and testing must meet standards for calibration and maintenance to ensure that errors will not impact test results. Testing equipment maintenance records must be kept in a LIMS, which will also generate notifications for regular maintenance and necessary calibration.

Testing

Acting as a single repository, LIMS system should have the capability of providing and selecting the proper methodology needed for all the types of tests required by a particular manufacturer. For each methodology, the LIMS must be able to oversee every procedure required throughout the process, along with the gathering and logging of resulting data.

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