The introduction of the STARLIMS Laboratory Execution System (LES) has made it much easier for technicians to document processes at the time they are being carried out (in-lab execution). Compliance with Standard Operating Procedures (SOPs) is promoted, improving efficiency and preventing transcription errors. In GxP regulated environments, several required peer-review steps are thus rendered unnecessary.

LEMS Basics

1) STARLIMS QM v12.2 features a workflow engine capable of configuring a sequence of steps to perform a lab execution. For example, a step may involve adding solvent to sample materials.

2) Steps are configurable, allowing associated parameters involving equipment and inventories utilized for the execution of a step to be documented with numeric parameters and free configurable text. Mandatory validation checks, such as verifying equipment was calibrated as required or consumables have not expired, are performed automatically.

3) User interface is optimized via a touchscreen capable of generating step-by-step instructions based on the configuration from the workflow engine. Thus, technicians receive guidance at each workflow step, which ensures compliance with SOP. In addition, parameters can be tracked conveniently through the scanning of barcodes with a hand scanner.

Lab Benefits

GXP Labs – Laboratories overseen by GxP regulations must coLABmply with stringent quality requirements during the whole process. STARLIMS LES has a robust capability in supporting document in-lab execution data. Should there be an audit, this data will be readily available.

ISO 17025 Labs – Laboratories that are ISO 17025 certified are required to prove that they are capable of providing results with great reliability. STARLIMS LES is quite capable of supporting and documenting the parameters involved in test method execution, with the additional value comparable to GxP scenarios.

LEMS Benefits

• Integrated with STARLIMS QM v12.2, LEMS will increase efficiency by streamlining workflows

• Improves consistency of SOPs, promoting regulatory compliance

• Support of ALCOA principle and data integrity compliance

• Ease of implementation by lab technicians via user interface utilizing an intuitive touch-screen

• Minimization of transcription errors by supporting a paperless laboratory approach

• Capture during in-lab execution of process data, which is then available for analytics / Business Intelligence solutions such as STARLIMS Advanced Analytics

Alpha LIMS Implementation

Alpha has been involved with the implementation of over 50 LIMS systems ranging in size from small, “off-the-shelf” software systems to very large, highly customized, multi-functional systems, including STARLIMS, for both governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha today at (410) 295-9500.