A strategic approach to LIMS design is critical to realize the full benefits of any LIMS platform. Not only will this ensure validation and compliance with all regulatory standards and quality controls, it will enable a system that properly suits your organizational needs and laboratory operations.
LIMS Design and Validation
Over the past two decades, LIMS platforms have revolutionized how laboratories manage their data. It’s more than just software – it’s become the workhorse of the laboratory, encompassing an array of functions and features to manage lab operations and improve productivity. Given the integral nature of LIMS to the modern lab, validation is critically important.
Proper validation of a LIMS will allow a laboratory to comply with regulations and also provide the necessary comprehensive documentation on the system to troubleshoot future problems. In order to achieve and maintain validation, LIMS features such as auto reporting, reproducibility, throughput, and accuracy must be quantifiable and verifiable so laboratories must establish protocols and standards for the validation process and associated documentation. While many commercial LIMS platforms are internally validated initially, any requested customizations or modifications will require revalidation.
Achieving Compliance and More Through LIMS Design
In addition to facilitating quality control activities, such as in-process testing, sample testing, and results analysis, proper software design can enable compliance through:
- Modernization of quality control systems
- Decrease in lost inventory
- Reduction in data logging and human error
- Improvements in workflow and data management
- Increased integration with clinical systems and lab instrument information
- Improved employee productivity
Beyond quality control benefits, LIMS platforms also have security features that address privacy, regulatory compliance, and data consolidation requirements of laboratories. Some of these features include:
- User Access
- Lightweight Directory Access Protocol (LDAP) And Active Directory Support.
- Role-Based Security
- User Constraints
- User Groups
- Auto Log Off
LIMS Master Data Optimization
Master data is what ultimately runs your LIMS platform, making master data design critically important as it will have multi-million dollar impacts on productivity, return on investment, and ongoing system maintenance.
As you approach the master data process, your business will want to decide what level of complexity you’d like to build towards in your master data:
- Digital – At one of the spectrum of LIMS master data is the fully digital approach. Building your LIMS to that end is a massive undertaking and has implications to long-term maintenance but yields equally substantial benefits ultimately.
- Final Results Only – A final results only approach gets you in to a system and if planned for properly, can be done in a way that gives you the foundation to start building towards less paper. While user adoption is generally easier and system maintenance is less involved, you are not able to realize the full benefits of a LIMS platform.
- Mixed – Sitting in the middle, this approach will incorporate specific areas of your lab. A great implementation will balance available resources with potential benefits to determine what can and should be tackled.
How you approach both validation and master data in LIMS design will have significant impacts on the return on investment your business is able to achieve from a LIMS platform. With a strategic approach, you’re ensuring both bottom-line benefits as well as innumerable benefits to your lab efficiency and productivity.
Listen to our LIMS Design Optimization webinar today to hear more detail, learn how we’ve approached LIMS design and implementation challenges with our clients, and understand the full range of benefits your business can realize.
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Contributions by Ben Gaise.