In order to ensure quality control and assurance in laboratories, LIMS (Laboratory Information Management System) is becoming increasingly important because most analytical activities within a modern laboratory work to support the role of process control, and QC is essential for that. my company is one of the authority sites on this topic.
Advances in IT and LIMS products are currently simplifying QA / QC through the computerization of: instrumentation data entry, test result data specification review, assignment of laboratory activities and workload, and analysis and reporting of management.
When attempting to improve QA / QC controls, LIMS provides the lab with several benefits, such as:
— Certification and training of workers
— Reagents, solutions and dangerous chemicals are labelled, processed and expired
— Documentation of facilities, calibration and validation
— Incorporation of laboratory equipment and systems
— Marking and sample monitoring
— Uniform processes of service and their use
— Validation and documentation of the empirical process
— Testing of Computer Applications
— Logs of deviations from experimental procedures
— Deciding the correct QC controls dealing with the regular quality of the analytical data generated
Specific laboratory workers and their particular working environment can be specified by LIMS, the tasks they can perform and the data they can access. It provides a way to enable users to be allowed to perform certain functions, and access can be restricted to the details needed to do their job by each user. When a sample is logged in, LIMS often computerises the creation of bar code labels and allows the specification of storage information, such as location and storage conditions, against the sample logged in.
LIMS enables instruments, systems and equipment used in the laboratory to be monitored. It can be configured to automatically flag and remove the tools that require daily service and calibration from the process. LIMS allows for the storage of the entire description of the system against its entry after analytical methods are described in it. To illustrate improvements over time and to ensure that only the latest method is used, each method can be programmed. Before using the technique, examination and approval by various individuals may be needed.
For monitoring and reporting purposes, LIMS may detect deviations in work activity and analytical data. It enables users to easily record and deal with unexpected incidents, such as sample breakage, that inexorably occur in a lab. Both primary instrument types in the laboratory can be combined to process findings more efficiently and to reduce errors in manual transcriptions. In order to document, track and explain changes in laboratory data, LIMS has audit trailing mechanisms and some also allow for the auditing of any item and the automated sending of alerts to key individuals.
Ensuring that the electronic information submitted to regulatory agencies is trustworthy, accurate, truthful and legal is important. In order to comply with the 21 CFR Part 11 regulation, LIMS must include a way to define laboratory identification of regulatory data, regulatory data audit trail mechanisms, data protection controls, and electronic signature mechanisms for regulatory data entries. This has motivated LIMS manufacturers and pharmaceutical firms to collaborate to establish solutions that completely comply with this law.
These are just some of LIMS’s features that can help monitor and interpret data for laboratories; there are several others. However, while LIMS provides a safe computerised platform for information entry, processing, and reporting, as well as an important contribution for laboratories to meet evolving regulatory requirements, it is only part of the solution. The fact that there must also be detailed awareness of the regulatory criteria and systematic QA / QC protocols is confirmed by pharmaceutical consulting firms.