Laboratory Execution Systems (LES) can be a valuable addition to an existing LabVantage Laboratory Information Management System (LIMS). For it to be utilized to the fullest potential there are some LES best practices that should be reviewed and applied. Before diving into best practices, let’s first highlight where LES can be utilized in LabVantage. 

• Test Methods: When testing a single analysis, an LES can be used for test methods to guide an analyst through the assay while simultaneously recording data and results, such as quality testing on a consumable or a single pH analysis. 
• Analytical Quality Control (AQC) Methods: LES can be utilized for AQC Methods by providing a template for a grouping of tests of the same analyses from multiple samples. These LES templates are specifically designed to include multiple samples and any blanks and/or controls for testing a batch of samples, or a run, versus a single sample. 
• Consumables: Another term for Standards, Reagents, or other inventoried materials, consumables can utilize an LES template for guiding and documenting the process of mixing reagents.  
• Instruments: LES for instrumentation is valuable for detailing steps required for maintenance or calibrations and documenting the completion directly in LIMS.  

Understanding and Establishing Standards for LES Framework 

When beginning to implement LES, it is vital for the implementation team to have a thorough understanding of the templates and master data that drive LES. The layout and settings of a template determine the organization of the worksheet, the review and approval settings for a worksheet, and the e-signatures. Fields on the worksheet can be set to required or optional and can be in different formats such as informative, free text or use checkboxes and drop-down lists.  

Having a firm grasp of the template as the driving force of the worksheet and the unique characteristics of each type of LES template ensures the requirements align with company and GxP requirements. Utilizing subject matter experts (SMEs) who are experienced in assisting organizations with establishing these settings can be a worthwhile investment as well. 

LES Best Practices 

Review Existing Mater Data  

LES is a module layered on top of the master data for Test Methods, AQC Methods, Consumables, and Instruments. Because of this, it is important to review the master data for any objects that will use LES prior to beginning the LES build. If there are any changes to the LIMS master data needed, these should be completed first. Doing this will help limit rework of the LES master data, as changes to the test method or AQC Method may result in necessary changes.  

Some examples of master data that should be reviewed include the Test Method or AQC Method components, AQC Method controls, Consumable recipes, and Instrument set up in LIMS. Once the LES is in use, LES master data should be reviewed anytime there is a change to the corresponding object or governing document to verify agreement or identify required changes. 

Consistent LES Builds 

One way to encourage adoption of new LES processes and decrease frustration among end-users is to develop consistent LES builds. Procedures and work instructions clearly outlining the standards for building and maintaining LES master data help to promote consistency. For organizations with global LIMS and multiple locations utilizing LES, standards should be established at a global level so that consistency is achieved across all locations. If an organization is moving from a paper copy of a worksheet to a digital LES worksheet, it might mean mirroring the order and process flow of the paper worksheet on the new paperless LES.  

Consistency also refers to the general LES worksheet layout for different test methods. Since lab analysts usually perform multiple tests within a specific department, it can be beneficial for the LES to have a common arrangement. This can increase efficiency and decrease the risk of mistakes if LES worksheets have a predictable layout.  

LES Inclusions 

It is recommended to complete a proof of concept for at least one object and have it reviewed by SMEs who can help identify gaps in the worksheet master data or misunderstanding of requirements. When starting with building LES, the amount of detail to be included should also be agreed on.  

Does the LES aim to replace paper forms? Does it aim to provide detailed step-by-step instructions on how to perform the analysis like an SOP? Does it aim to do both? Answers to these types of questions and having a clearly defined goal of the LES aids in determining which information will be included. It is important that LES includes the information necessary for execution of the method without being difficult to execute for the analysts in the laboratory.  

If one of the goals of implementing LES is to work towards a paperless laboratory, it is important to examine the needs of data captured on the LES. Some questions to consider include: 

• Will instrument calibrations and maintenance move from a paper logbook to being recorded in LIMS?  
• Does implementing LES impact how the organization will document raw material inventory and quality testing?  
• How will instrument printouts be recorded or stored? 
• Which documentation and data retention procedures will need to be updated to accurately reflect any changes due to the reduction of paper use? 

Training 

Training usually occurs towards the end of the project timeline, impacting resources such as personnel, finances, and time. Investing in thorough training will benefit the organization in the short- and long-term.  

For all end users, a cohesive training course will increase confidence when utilizing the new LES. For GxP environments, training includes defining the necessary competencies for the LES user, developing an effective training program, and documenting completion that demonstrates competency. Demos, hands-on exercises, and work instructions are examples of training features that are effective. For those already familiar with LabVantage LIMS, implementing LES impacts the method of recording data and results, so training for experienced users should not be overlooked. Lastly, appointing super users can be valuable as a first line of support when issues or questions arise. 

Training, procedures, and work instructions for building LES master data is an important foundation to ensure that LES master data is accurate and consistent as well. For large organizations where multiple resources may be working on maintaining LES, strong training will help maintain consistent builds that follow approved standards. 

Looking Ahead 

When starting on an LES implementation, it is essential to apply these LES best practices so that all features of the module can be leveraged and implemented effectively. Clarkston Consulting has the expertise and experience to help organizations ensure success with LES. Contact our LIMS experts today for guidance.