Embracing digital laboratory transformation with LES

July 19, 2023

The pharmaceutical industry is embracing a digital transformation by using Pharma 4.0 laboratory solutions. One of these solutions is Laboratory Execution System (LES) software which is designed to digitalize the lab processes, data transfer, and reporting. It is a step towards paperless laboratories with digital workflows and documentation. It aims to achieve accuracy by reducing errors and increasing efficiency with the goal of attaining regulatory compliance.

While digital sample tracking and record-keeping systems are now common within pharma labs, a relatively new player in the game is Laboratory Execution System (LES). LES is focused on the execution of laboratory processes and workflows in real-time, while other digital solutions like LIMS is primarily focused on sample management and tracking, and ELN is focused on electronic documentation. LES systems are a much more intimate interface with lab equipment and are specifically designed for laboratory operations to automate and streamline laboratory processes by providing a comprehensive solution for data capture, processing, and management.

The implementation of LES in laboratories brings its own challenges. The key challenges and potential solutions to implementing LES are:

1. Validating the system:

Validation of LES proves that the software is performing what it intends to do. Validation is an essential step to ensure that the system is compliant with regulatory requirements. However, the validation process can be very time consuming and resource intensive, keeping the complexity of the system in consideration. LES manages critical data and processes; therefore, it requires a significant amount of testing and documentation to ensure regulatory requirements and maintain data integrity.

Solution: The validation process can be streamlined by including clear objectives and testing protocols in a comprehensive validation plan. A good assessment of risk and clear requirements enhance the efficiency of validation.

2. Interface with existing systems and equipment:

The implementation of LES can be challenging when legacy systems or different types of equipment are in use. The availability of different equipment can raise compatibility issues and can make the integration complex.

Solution: Identify the potential interface issue by conducting an evaluation of laboratories, including all the existing equipment and systems. Developing a detailed integration plan will support in identifying risks and shortcomings. Involving different vendors and software developers can ensure compatibility and effective integration.

3. Change Management:

Implementing a change is always challenging. The switch from legacy or manual systems to LES can be difficult for users and require training.

Solution: It is critical to involve the end user from the beginning of the process. An intuitive and user-friendly system with training support can make users easily accept the new system. The communication of change at the “right time” with a clear strategy paves a smooth path for user acceptance.

4. Digitalizing the protocols and Data Management:

Managing data can be challenging when a vast amount of data is generated in various formats. Similarly, SOPs with variations are challenging to digitalize.

Solution: Efficient data management requires a detailed data management plan ahead of implementation and adoption of harmonized processes and data formats.

5. Maintaining the validated state over time:

To maintain regulatory compliance, the system must stay in a validated state, even as the system expands to include new features or grow over time. Therefore, each new version and update need to be validated.

Solution: Alignment with the vendor for the timeline and type of regular updates can help in assessing the need for validation. Preparing a detailed application and technical plan with a defined timeline for periodic and user review will maintain the validated state of the system over time.

LES is a powerful tool in the Pharma 4.0 toolkit.

When well utilized, it can provide significant benefits to pharmaceutical and life science industries and reduce errors and data integrity issues in the lab. However, the implementation of LES has its own challenges. Early identification of potential challenges, detailed plans, clear strategies, and comprehensive knowledge of the validation process can ensure successful implementation. Success can be achieved by keeping attention to detail and carefully addressing critical aspects like interface, validation, change management, and process and data format harmonization.