LIMS (Laboratory Information Management System) is becoming more and more crucial to ensure quality control and assurance in laboratories, because most analytical activities within a modern lab work to support the process control function, and QC is vital for that.
Currently, advances in IT and LIMS products are simplifying QA/QC through the computerization of: data entry from instrumentation, test result data specification review, assignment of lab activities and workload, and management analysis and reporting.
LIMS offers many advantages to the lab when trying to reinforce QA/QC controls such as:
– Personnel qualification and training
– Labeling, storage, and expiry of reagents, solutions and hazardous chemicals
– Equipment documentation, calibration and validation
– Integration of lab instruments and systems
– Labeling and tracking of samples
– Standard operating procedures and their use
– Analytical method validation and documentation
– Computer software validation
– Records of deviations from lab procedures
– Determination of the right QC controls, which deal with the daily quality of analytical data developed
LIMS can define specific lab personnel and their particular working environment, defining the activities they can perform and information they can access. It offers a way to allow users to be approved to do certain functions, and the access can be limited to the information each user requires to do their job. LIMS also computerizes the production of bar code labels when a sample is logged in, and permits the definition of storage information, like location and storage conditions, against the logged in sample.
LIMS allows for the tracking of instruments, systems, and equipment used in the lab. It can be programmed to automatically flag and remove from operation the instruments that need regular service and calibration. After analytical methods are defined in it, LIMS allows for the storage of the whole method description against its entry. Each method can be programmed to show changes through time and to ensure that only the latest method is used. Review and approval by different persons can be required before using the method.
LIMS can identify deviations in work practice and analytical data for tracking and reporting purposes. It allows users to easily record and deal with unexpected events that inexorably happen in a lab, like sample breakage. It can be merged will all principal instrument types in the laboratory to process results faster and to reduce errors in manual transcriptions. LIMS has audit trailing mechanisms to record, track, and justify changes in lab data, and some even allow for the auditing of any item and the automatic sending of notifications to key individuals.
It is vital to ensure that the electronic data submitted to regulatory agencies is trustworthy, reliable, authentic and legal. In order to comply with the 21 CFR Part 11 rule, LIMS has to provide a way to specify identification of regulatory data with the lab, audit trail mechanisms for regulatory data, security controls on the data, and mechanisms for signing electronically the regulatory data entries. This has promoted the cooperation of LIMS vendors and pharma companies to develop solutions that fully comply with this rule.
These are only some of the characteristics of LIMS that can help laboratories control and analyze data; there are many others. However, although LIMS offers a computerized secure framework for inputting, processing, and reporting information, as well as an important contribution for labs to comply with the changing regulatory requirements, it is only a part of the solution. Pharmaceutical consultancy firms reinforce the fact that there must also be a thorough knowledge of the regulatory requirements and comprehensive QA/QC procedures.