Spectrometer Software Manual

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Laboratory Information Management Systems and Traceability of Quality Systems

Today's business environment places many demands on technical managers and corporate executives. At a time when global competition forces companies to introduce products at a faster pace with higher efficiency and productivity, quality systems like ISO and Six Sigma, stipulate rigorous testing documentation. Regulatory systems, such as Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), require examination of manufacturing components— raw materials, production intermediates, and finished goods— together with meticulous records of every action and result. Customers routinely insist that manufacturers keep auditable schedules and thorough documentation as a condition of doing business.
These factors place strict guidelines on data management and document handling by manufacturing organizations and the testing laboratories that support them. Data archiving, retrieval, and auditing must provide traceability, accountability, and compliance with regulations. LIMS is an excellent mechanism to meet these complex data management requirements and to facilitate the move to an electronic records environment in compliance with the electronic data integrity requirements of the U.S.
FDA (21 CFR Part 11), U.S. EPA, OSHA (Occupational Safety & Health Administration), and their international counterparts.

Traceability, accountability, and quality

Traceability is defined as "the property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties." In a strict sense, traceability refers to results of measurements by scientific instruments. It is not the property of the instrument, the calibration report, or the originating laboratory. A traceable measurement is performed in a measurement system (i.e., analytical instrument) that is clearly understood and under control. Traceability implies that the instrument is subjected to a quality assurance program; is calibrated; is regularly tested against a standard reference before, during, and after sample measurement; and has established measurement uncertainty (commonly reported as variance or standard deviation)2 for every step in the process.
In a broader sense, traceability includes accountability to customers, regulatory agencies, and quality systems. It extends to recordkeeping, sample tracking, staff training, certification maintenance, and more.

A result would be considered traceable when documented procedures exist (supported by meticulous records) that demonstrate very low risk of error, which adds more items beyond equipment maintenance and calibration.
This article describes what it takes to establish traceability, accountability, and quality in a testing laboratory, and how a LIMS facilitates the process.

LIMS and traceability
A LIMS stores information in a relational database, such as Oracle (Oracle Corp., Redwood Shores, CA), DB2 (IBM, White Plains, NY), or MS SQL (Microsoft, Redmond, WA). Each table in the relational database is assigned a primary key, e.g., a column or set of columns, whose values uniquely identify every row (record) in the table. Tables are related to each other by using foreign keys. A foreign key in one table (the foreign table) contains a value corresponding to the primary key of another table (the primary table).
This relates the information in the foreign table to that in the primary table. The use of foreign keys allows the LIMS to establish links between samples, storage conditions, test dates, analyst certifications, instrument calibration, and testing parameters. Most LIMS provide an interface that takes the place of direct SQL queries to the database.

Maintaining a quality organization
For reliable data generation, each aspect of the laboratory performance must meet quality standards. Staff needs to be trained and certified in equipment use and sample handling.
Training must be current and certified by an external organization. Equipment must be regularly inspected, maintained, and calibrated. Controls must be an integral part of the measurement cycle. To prove chain of custody, samples require tracking from receipt through analysis, through data entry and approvals up to the final report. Every action must be logged, and every record properly signed and archived for future retrieval.
A compliant LIMS follows the laboratory workflow at every step. It accepts manual sample and data entries, uploaded documents, and computer file attachments (faxes and word processor and spreadsheet files) and stores them in a database. It communicates with analytical equipment. It schedules laboratory work, equipment maintenance, and staff training, and updates staff, managers, and customers with the latest information.
A compliant LIMS product makes policy enforcement, data integrity, and traceability an easy reality.

LIMS and electronic record-keeping
Modern scientific instruments, such as spectrometers, chromatographs, and microscopes, generate data in electronic formats using integrated or external data acquisition and processing systems. Older equipment has (or can be retrofitted with) serial ports to transfer data to external computers. Modern LIMS software can interface with scientific equipment through the network to automatically retrieve and store the information in a database without the need for human intervention.
The data fields provided by analytical instruments often include technician and sample details, operational parameters, and analyst's comments, in addition to the technical data
(e.g., spectrum, chromatogram, and image). The LIMS collects and processes the instrument data for archiving and retrieval. For increased security and performance, the data are stored in an external database server running Oracle or MS SQL. These database servers offer redundancy, high availability, fault tolerance, and strong security.
A good LIMS is flexible and configurable, and allows automated entry of additional fields.
With such flexibility, a single data archive format can be generated by different instruments, and data collection is easily updated when the instruments or their software are upgraded.
StarLIMS from L.I.M.S. (USA) Inc. (Hollywood, FL) has a Data Capture Utility (DCU) that automates numerical data entry from all principal laboratory instruments.

Data is collected through the network, allowing simultaneous access to multiple instruments without requiring direct connection or even physical proximity.
The full automation of results entry reduces technician workload and eliminates transcription errors.
StarDOC, a StarLIMS module, captures and archives unstructured data (spectra, photos, and other documents) in accordance with 21 CFR Part 11. A unique ID number is created for each data file. This ID, sample information, and raw data are all stored together as a single entity, as required by GLP. These data are easily tracked, sorted, and retrieved at any time. It is possible to view the data using the StarDOC utility, the original applications that generated the data, and a special viewer such as the ACD spectral viewer.
For more information visit: www.starlims.com

About the Author

References
1. http://www.nist.gov/traceability/suppl_matls_for_nist_policy_rev.htm.
2. http://physics.nist.gov/cuu/Uncertainty/index.html.

Dr. Grauer is Scientific Director, L.I.M.S.
(USA) Inc., Presidential Bldg., 4000 Hollywood
Blvd., Ste. 515 South, Hollywood, FL
33021-6755, U.S.A.; tel.: 954-964-8663;
fax: 954-964-8113; e-mail: zvig@starlims.com.