CSols has been delivering successful Laboratory Execution Systems (LES) for over five years.
The benefits of implementing a LES are well documented and include:
- Automated method execution
- Improved data integrity
- Reduced review time with the potential to review by exception
- Reduced/Eliminated transcription errors through instrument interfacing
- Real-time digital display of effective versions of SOP/MTD document
- Direct interfacing and data collection from internal/external systems and equipment providing error protection (e.g., only instruments within calibration are useable).
- Inventory Management of consumables protecting against such events as using expired consumables
- Paper worksheet, logbook, and notebook reduction
CSols provides a number of LES specific services to help your organization realize the full potential of your LES implementation. These services include:
- LES Full System Implementation:
- LES Project Management
- LES Lab Informatics Systems integration
- LES Instrument Integration
- LES Enhancements and Extensions
- LES Training
CSols LES Implementation Services
Our LES implementation services range from full solution implementation to integrating and enhancing your existing system and everything in-between. CSols recognizes that a LES is often implemented in stages or phases, so to ensure that you get the most out of your LES, CSols will work with you to analyze your LES implementation to help guide you to the realization of greater benefits for your organization and company.
LES Full System Implentation
Implementing a LES can be accomplished utilizing several different approaches; however, a phased approach is generally the most common. When implementing a LES via a phased approach, each step along the path should be designed to yield increasing value and benefits for an organization. This is often accomplished by designing and adding successive reusable method automation solutions as well as the establishment of standardized data vocabularies and other taxonomies.
Beyond method automation, expanding the LES’s capabilities in successive phases will also increase the value and benefit level of your solution. Examples of popular LES capabilities that CSols has implemented in a phased manner include:
- Automated Material Qualification
- Automated Instrument Qualification
- Reference Standard & Critical Reagent Management
- Consumable Inventory Management
- Instrument Calibration & Maintenance
- Paper Worksheet, Logbook and Notebook Reduction
- Interfacing of Instruments to LES
- Chromatography Data Systems (HPLC, UPLC, LC/MS, etc.)
- Plate Readers
- pH Meters
- Integration of Systems to LES
- Asset Management Systems
- Reporting Tools
LES Project Management
A LES is not just another IT system that any project manager can plan and manage. A LES is a complex laboratory informatics software system. The project management surrounding such a system requires specialized knowledge and experience to ensure success. Regardless of whether you are doing your initial LES implementation, increasing your LES data capture levels, or expanding your LES’s capabilities, it’s important to recognize that Project Management will be critical to the success of your project.
Further, we believe that the classic definition of project success (on-time, within budget, and satisfying the requirements) leaves out a critical element – the use and adoption of the LES! Without considering all the stakeholders needs, involving them, and managing how they perceive and receive the laboratory informatics system, you may very well have a “successful” LES implementation but no one will use the system.
So CSols doesn’t just provide LES-oriented Project Management, we will also work with your organization to manage the change the implementation will inevitably drive. In this way, you will have a truly successful LES project that meets your requirements, is delivered on-time and within budget, and that will be adopted and used by all the stakeholders.
Deliverables: Project Charter, Project Plan, Risk Analysis, Resource Plan, Governance Model, Status Reports, Issue Tracking and Resolution, and Project Closeout.
LES Laboratory Information Systems Integration
When running a LES in a QA/QC environment, it will be likely that the data and information you have captured in the system will need to be transferred to or combined with data from another informatics, laboratory information, or manufacturing information system. Some examples of these systems would include: Inventory Management, Freezer Management, LIMS, Data Historian systems, ERP, CAPA systems, and document management systems. The transferred or combined information can then be used to drive both scientific and business decisions.
Regardless of the type of laboratory environment your LES is operating in, integrating data from multiple disparate systems can be both complex and problematic. We have utilized a variety of API’s, middleware systems, database integration tools, web services, and custom programs to accomplish our clients’ LES integration goals. Knowledge and experience utilizing integration tools is essential, but even more important to success is CSols’ understanding and knowledge of the LES systems and architectures as well as how laboratory data is used across an organization.
Deliverables: Requirements Definition, Design Documents, Configuration Documents, System integration code and configuration, Unit test scripts, Integration test scripts.
LES Instrument Integration
Integrating your instruments to your LES, beyond simple cutting and pasting, has long been recognized as an industry best practice. Doing so will reduce transcription errors, increase data quality and integrity while simultaneously improving your lab’s productivity and effectiveness. Additionally, integrating your lab instruments greatly improves the analyst’s workflow by removing tedious manual data entry and cut and paste tasks. Improving the workflow of the analyst is a key factor in increasing laboratory information system adoption and utilization.
We have interfaced virtually every type/brand of instrument and instrument system to a wide range of laboratory information systems. CSols, additionally, has expertise with a variety of commercial middleware systems and several traditional integration packages that may or may not be utilized depending on the LES you have implemented. Instrument interfaces that CSols have developed and implemented run the gamut from a simple one-way data transfer to sophisticated, workflow driven, multi-step programmatic interfaces.
Some of the more popular instruments and instrument systems that have been integrated include:
Interfacing of Instruments to the LES
- Chromatography Data Systems (LC, LC/MS, GC, etc.)
- Plate Readers
- Particle Counters
- Karl Fischer Titrator
- Balances & pH Meters
Deliverables: Instrument interface program/code, Requirements Definition, Design and Configuration Documentation, Test scripts
LES Enhancement & Extension Services
Whether you have recently completed your initial implementation of your LES or have been in operation for years, your needs and requirements will invariably expand and change. To satisfy your changing needs it is common to implement features and capabilities that may not have been used previously, were not available in an older version and are now available as standard, or to support new laboratory processes, workflows, testing methods, information sharing requirements, etc.
We have also found that over time an organization will often seek to adjust how their LES is utilized. Having started with the transcription of SOPs into an electronic format that enforced the order of execution of method steps (paper under glass) they seek to improve productivity through increasing the level method automation. This is accomplished by applying such techniques as automatic data entry verification, instrument interfacing, inventory adjustments, etc.
CSols will leverage our experience, knowledge, and expertise to ensure that any new configuration or enhancement of your LES will be accomplished in the most efficient, scalable, and supportable way to satisfy both current and future needs. Our team can manage the systems analysis and feedback loops, perform needs and risk assessments, and gather workflow/SOP/template requirements. Additionally we offer deployment support for new or existing templates and methods or as you expand the use of your LES to other labs and departments.
Some examples of LES Enhancements that CSols have developed and delivered include:
- Automating additional methods/SOPs
- Adding Instrument Interfaces
- Replacing paper worksheets, logbooks and notebooks
- Addition of consumable inventory management and use tracking functionality
- Integration of inventory systems, etc.
- Adding additional metadata which is either automatically or manually captured
Training is critical to the successful adoption of your LES solution. Commercial-Off-The Shelf (COTS) ELN and LES vendors will generally offer a series of training programs often based on the functions of the system. This type of training is usually designed for super users and system administrators rather than end users. Moreover, the training materials utilized and the training courses themselves will be based on a generic system, not your implemented system that has been configured and/or customized to meet your specific needs.
CSols’ LES training experts have a long, successful track record in the preparation of customized, role-based (technician, researcher, supervisor, partner, system administrator) laboratory information system training materials and classes. Give your organization autonomy by providing specialty training in method automation and template configuration to in-house experts. Our LES training materials and classes can be oriented toward delivery in a classroom setting, as computer based training modules, or for “train the trainer” consumption.
Deliverables: Role-based training courses, Customized training materials, Training workbooks.