Regulated laboratories must comply with numerous quality requirements that are put in place by regulatory agencies to ensure that accurate data is being generated and reported. The vast majority of laboratories strive to generate high quality, accurate, affordable data. To achieve this, they acquire LIMS solutions and automation to help them in implementing quality measures, a few include, positive ID, SOPs (Standard Operating Procedures), Method Validation, known standards included in runs, equipment maintenance and calibration and provide team members specialized training. These requirements touch upon various processes throughout the sample lifecycle, and begin at Sample Login, where each sample must have a unique sample ID. To ensure that samples are properly labeled, without transcription errors, many laboratories leverage positive ID, such as 1-Dimensional or 2-Dimensional barcoding or RFID (Radio-Frequency Identification). Once samples are logged into the system, they must be managed, tests and QC assigned and tracked through sample disposal. To ensure quality, each step of the analysis is tracked, monitored and all chemicals, supplies and reagents are tracked and traced throughout the analysis process. Analytical instrumentation is monitored, managed and calibrated with all the results recorded. Instrument data is electronically imported to eliminate transcription errors and other controls and sensors are put in place to eliminate human errors. Restful APIs are utilized to accelerate communication with other enterprise systems. System auditing allows auditors to understand why results were altered and to see the number of audits over time.
1. Discuss the Role of a LIMS in a Quality Management System.
2. Recognize that there are many other systems that are tightly integrated with LIMS, which scientists may not be aware or, which are available to further cost effectively facilitate data integrity.
3. List the key features and functions of a LIMS.