| LIMS (Laboratory Information Management System) | | | | to show changes through time and to ensure that |
| is becoming more and more crucial to ensure quality | | | | only the latest method is used. Review and approval |
| control and assurance in laboratories, because most | | | | by different persons can be required before using |
| analytical activities within a modern lab work to | | | | the method. |
| support the process control function, and QC is vital | | | | LIMS can identify deviations in work practice and |
| for that. | | | | analytical data for tracking and reporting purposes. It |
| Currently, advances in IT and LIMS products are | | | | allows users to easily record and deal with |
| simplifying QA/QC through the computerization of: | | | | unexpected events that inexorably happen in a lab, |
| data entry from instrumentation, test result data | | | | like sample breakage. It can be merged will all principal |
| specification review, assignment of lab activities and | | | | instrument types in the laboratory to process results |
| workload, and management analysis and reporting. | | | | faster and to reduce errors in manual transcriptions. |
| LIMS offers many advantages to the lab when trying | | | | LIMS has audit trailing mechanisms to record, track, |
| to reinforce QA/QC controls such as: | | | | and justify changes in lab data, and some even allow |
| - Personnel qualification and training | | | | for the auditing of any item and the automatic |
| - Labeling, storage, and expiry of reagents, solutions | | | | sending of notifications to key individuals. |
| and hazardous chemicals | | | | It is vital to ensure that the electronic data submitted |
| - Equipment documentation, calibration and validation | | | | to regulatory agencies is trustworthy, reliable, |
| - Integration of lab instruments and systems | | | | authentic and legal. In order to comply with the 21 |
| - Labeling and tracking of samples | | | | CFR Part 11 rule, LIMS has to provide a way to |
| - Standard operating procedures and their use | | | | specify identification of regulatory data with the lab, |
| - Analytical method validation and documentation | | | | audit trail mechanisms for regulatory data, security |
| - Computer software validation | | | | controls on the data, and mechanisms for signing |
| - Records of deviations from lab procedures | | | | electronically the regulatory data entries. This has |
| - Determination of the right QC controls, which deal | | | | promoted the cooperation of LIMS vendors and |
| with the daily quality of analytical data developed | | | | pharma companies to develop solutions that fully |
| LIMS can define specific lab personnel and their | | | | comply with this rule. |
| particular working environment, defining the activities | | | | These are only some of the characteristics of LIMS |
| they can perform and information they can access. It | | | | that can help laboratories control and analyze data; |
| offers a way to allow users to be approved to do | | | | there are many others. However, although LIMS |
| certain functions, and the access can be limited to | | | | offers a computerized secure framework for |
| the information each user requires to do their job. | | | | inputting, processing, and reporting information, as |
| LIMS also computerizes the production of bar code | | | | well as an important contribution for labs to comply |
| labels when a sample is logged in, and permits the | | | | with the changing regulatory requirements, it is only a |
| definition of storage information, like location and | | | | part of the solution. Pharmaceutical consultancy firms |
| storage conditions, against the logged in sample. | | | | reinforce the fact that there must also be a |
| LIMS allows for the tracking of instruments, systems, | | | | thorough knowledge of the regulatory requirements |
| and equipment used in the lab. It can be programmed | | | | and comprehensive QA/QC procedures. |
| to automatically flag and remove from operation the | | | | If you liked this article, tell all your friends about it. |
| instruments that need regular service and calibration. | | | | They'll thank you for it. If you have a blog or |
| After analytical methods are defined in it, LIMS allows | | | | website, you can link to it or even post it to your |
| for the storage of the whole method description | | | | own site (don't forget to mention as the original |
| against its entry. Each method can be programmed | | | | source). |