Glossary
Laboratory Execution System (LES)
What is Laboratory Execution System (LES)?
A Laboratory Execution System (LES) in pharma is a software application that supports systematic, documented execution of laboratory processes and workflows. It guides user through procedures with prompts to enter data manually or electronically. LES is often used in regulatory areas like pharmaceutical industry to ensure compliance with regulatory requirements. It helps automate and streamline laboratory processes, reducing errors increasing efficiency.
How does LES support laboratory operations?
LES supports laboratory operations in following ways
- LES enables compliance with standard operating procedure (SOP) and regulatory requirements. It guides technicians through defined workflows and protocols, ensuring all steps are followed correctly and documented.
- LES automates and streamlines laboratory processes increase efficiency. It can integrate with instruments and devices to automatically capture data and manage samples.
- LES improve data accuracy and integrate by eliminating manual transcriptions errors. All activities are logged, and time stamped, providing a complete audit trail.
What are the key benefits of LES in pharma?
LES provides numerous benefits that enhance operational efficiency regulatory compliance and overall quality.
- Regulatory Adherence
- Efficient Scheduling
- Standard operations procedures
- Real time monitoring
- Risk Mitigation
- Integration with other systems (Laboratory Information Management Systems LIMS)
How does LES support regulatory compliance?
LES ensure regulatory compliance by standard protocols and SOPs, guaranteeing that all laboratory activities are performed well. The LES has been thoroughly validated to meet regulatory requirements and ensure that functions are intended to comply with standards such as FDA 21 CFR Part 11.
