Laboratory execution system

A pharmaceutical quality control laboratory represents one example of a place where a laboratory execution system (LES) may be used.

A laboratory execution system or LES is a "computer system used in the laboratory at the analyst work level to aid in step enforcement for laboratory test method execution," according to ASTM International.

Purpose and use

The general purpose of an LES is to direct the laboratory user to follow specific steps to ensure the rigidity of a test method or process' end results, though alternate workflow routes may be applied in specific circumstances. A lab technician would follow prompts from the system at every step of a method or process and sign off at each step through the LES.

Historically, some have considered the LES a sub-branch of an electronic laboratory notebook (ELN) specifically made for laboratories engaging in quality control and quality assurance applications with rigid test methods, while others may consider it simply a separate set of functionality which may be found in an ELN or a LIMS. Some in the industry suggest the term "laboratory execution system" is a vendor-led morphing of the "method execution system," which was originally designed "to address the problem of standard operating procedure (SOP) compliance."

Aside from workflow step enforcement, a LES may have a variety of other functionality, including:

• management of standard operating procedures (SOPs);
• validation of inputs, calculations, expiration dates, instrument interfaces, etc.;
• acquisition or importing of procedural data from other systems into one common system;
• automation of calculations;
• verification of steps or results and sign-off using electronic signatures;
• support for audit trails with timestamps;
• management and alerting of non-conformances and out-of-specification results; and
• integration with third-party software, e.g., middleware, statistical processing, data mining, and data visualization applications.