Definition

Good Automated Laboratory Practices (GALP)

Good Automated Laboratory Practices (GALP) is a standardized set of best practices that are used to ensure data integrity for laboratory data that is gathered, processed, and archived by a laboratory information management system (LIMS). The GALP was developed to establish guidelines for automated data management in laboratories that supply data to the United States Environmental Protection Agency (EPA). The need for such guidelines has increased as a result of the ongoing shift from manual to automated procedures. Most data that is submitted to the EPA has been processed in some way by an LIMS.

The EPA's Office of Information Resources Management (OIRM) conducted extensive research into the practices used and resulting threats to data integrity. Among its findings, the OIRM reported that data was at risk because of inadequate security, poor verification practices, and inadequate documentation. Because the laboratories that provide EPA data are often independent, they may follow different procedures and have different policies. The purpose of the GALP is to establish guidelines for all laboratories supporting the EPA. With policies clearly articulated, Agency inspectors can use them in the inspections of laboratories. The EPA understands that absolute data integrity, like perfection, is unattainable; however, the GALP was created to minimize avoidable hazards.

This was last updated in July 2005

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