Since processors in most high-workload drug-testing laboratories have become automated, LIMS have become one of the most important developments in laboratory testing. They assist in accessioning specimens, storing records, collecting and processing records, producing results and providing QA functions. Usage of LIMS has allowed drug-testing laboratories, with their high volume of similar tests, to take special advantage and perform several repetitive functions prone to human error including barcode accessioning, tracking and cross-checking document information. Good at multi-tasking, LIMS facilitates performing several operations simultaneously with data streaming into the LIMS and being instantly associated with the specimen. Software is being included that instruct LIMS to oversee laboratory operations for compliance with criteria and allows results to be reported only when all requirements are fulfilled. For example, before releasing results to the customers LIMS may verify and ensure that test results actually exceed cutoff concentrations, calibrators are not expired, and QC samples have expected results; furthermore, among other things it should also certify that the scientists have completed their reviews. Electronically sent over secure networks, the results are usually complied without error-prone manual processing. It’s critical that the laboratories should have a QA process for their LIMS in additions to these important functions.
Available for purchase, some QA requirements for the LIMS are standard to the information technology industry (13). This incorporates: planes for implementing changes, software validation procedures, security of the hardware, policies for termination of access with password protected access, personal training requirements and records, virus monitoring procedures, software documentation and validation, licensing, disaster plans and backup procedures. Systems that deny access to unauthorized individuals and viruses in an industry area of concern in terms of security; the advent of wireless networks has made this even more crucial. Since records are sensitive and have a high propensity for sabotage by individuals who want to prevent their use to support adverse actions, security and anti-virus software are critical. Security requirements are often detailed in reference to drug testing and similar applications. The audit trail must identify the original entry, the new entry, the person who modified it and the time and date of the modification when a person amends a record. In short, all changes in records during processing or testing must be auditable; the records must be retrievable. The courts may wish to view the audit information, if the record has been changed, to ensure that the rights of the accused are not violated by the change.
To assure that the results are faxed only to remote sites that are secure and accessed by authorized individuals, the laboratories must have proper documentation. Electronic transfer of result demands the same requirements. By storing a file of authorized recipients and sending results merely to approved personnel, LIMS have made this assurance easier. Facilitating authorized customers to the password-protected result file, some web-based systems allow the laboratory to send results to the server. Additional safeguards are required by systems where servers are outside the direct control of the laboratory.