Lims and Traceability of Quality Systems

By: Dana H

An important part of traceability is keeping track of samples from the moment they arrive at the laboratory to the time results are reported. At a minimum, this means maintaining a relational database containing lot numbers, specifications, operator names, time stamps, and authorizer information, as well as electronic signatures for each sample. A majority of companies impose much stricter tracking requirements on laboratory data. This may be done to comply with regulations, to prevent litigation, or to protect intellectual property rights.

StarLIMS' automated electronic record-keeping goes far beyond that minimum. It includes test results and equipment settings that cover all sample movements, conforming to 21 CFR Part 11, which is becoming a model for global traceability standards. An integrated electronic record management module produces a completely auditable track record of all laboratory resources taking part in a specific analysis (scientists, instruments, standards, and standard operating procedures [SOPs]).

The role of a LIMS in a GLP/GMP environment is to help ease documentation of regulation compliance. Star- LIMS has extensive features to aid in this process. Modules facilitate maintaining versions of test methods, training certifications for analysts, log books for instrument maintenance, instrument standards and control charts, MSDS (Material Safety Data Sheets), and general material management and tracking. These modules are integrated into the StarLIMS workflow process.

For example, when assigning a test to a selected analyst, it is possible to automatically compare the certifications of the analyst to those required, and assign qualified analysts only to perform the test. StarLIMS also combines the ability to maintain schedules, content, and review questions for each certification course.

Data safeguarding

To produce data that will withstand even the closest scrutiny, a laboratory needs to implement strict controls. Critical elements to be included in a secure electronic data management system are monitors such as strict user access rules, document and data change control, transactional or silent audit trails, and password security.

StarLIMS supports peer review (requiring a peer to evaluate and approve testing data, thus preventing individuals from signing off on their own tests), auditable data change policy (requiring recorded explanation and authorization to change recorded data), report release hierarchy (mandatory manager review and signatures), and data security policy (password-protected individual computer accounts).

StarLIMS' integrated auditing tool links each sample to records on technician training and certifications, equipment maintenance, equipment control standards and calibration, and sample testing history.

Policy enforcement

Traceability requires auditable, recorded equipment maintenance and calibration schedules and regular equipment testing routines (daily, weekly, and monthly performance testing against known standards), but records do not guarantee compliance.

For instance, keeping records of equipment calibration does not prevent personnel from using noncalibrated equipment, or failing to use proper controls and standards. LIMS can be used to enforce policies.

For example, StarLIMS can be set to allow only authorized personnel to run specific tests. The work is automatically assigned, and unauthorized staff members are unable to run or sign the test. Tests would not even show up in an analyst's personal console unless he/she is authorized to run them.
Likewise, it is possible to tie the use of equipment to completion of scheduled maintenance, and to require that a QC standard be run before using the instrument to measure samples. All requirements have to be met for the instrument to run and log the samples.

The results of calibration and standardization runs can be used to determine measurement uncertainty and to clear the instrument for use in testing (if it passes specifications). An integrated scheduling tool facilitates creating and keeping track of equipment maintenance and personnel training schedules.

Conclusion

The right LIMS is an essential tool in improving the data quality and operational efficiency of technical organizations and testing laboratories. A LIMS logs every action and every record, enforces signatures, archives for future retrieval, and provides data integrity and traceability. It establishes sample chain of custody from receipt to final report. A LIMS can be used to monitor and enforce staff training and certification, equipment inspection, calibration, and maintenance by denying data entry unless all equipment maintenance and training requirements are met.

The use of LIMS electronic databases means that data can be easily tracked, sorted, and retrieved. Computerized records reduce paper use and lower the costs associated with manual filing, copying, and storerooms, while reducing handling errors and improving response times.

A LIMS is an excellent means of meeting complex data archiving, retrieval, and auditing needs, and for complying with electronic data integrity requirements of U.S. and international regulatory bodies.

For more information visit www.starlims.com

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