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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.^[1][2]

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.^[3]

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^[2][4][5][6], while others may consider it simply a separate set of functionality which may be found in an ELN or a LIMS.^[2][5][7] 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."^[8]

Aside from workflow step enforcement, a LES may have a variety of other functionality, including^[3][4][9]:

• 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.

References