What is a LIMS?

Since the primary purpose of a LIMS is to track and manage samples, they excel at summarizing sample test results, tracking reagents and enabling automated workflows to reduce the chance of human error during data input and processing. Many modern LIMS systems provide the following benefits:

• Sample-specific summaries of test results across multiple tests and protocols
• Reagent and lots tracking
• Purpose-built workflow automation which can help reduce human errors during data input and sample processing
• Centralization of access and storage of quality control data
• Integration with instruments or other in-lab systems to improve lab efficiency
• Improvement in quality and reproducibility of an experiment

A LIMS software is sample-centric rather than process-centric so it is not suitable for creating a BioPharmaceutical process data backbone that enables data capture, contextualization, visibility and insight across an entire process, or across multiple processes. The focus of a LIMS is on what happened in the experiment, but not why or how it happened.

This can result in limitations like the following:

• Lack of process-centric data capture decreases the visibility of end-to-end workflows, limiting insight that can be used to optimize processes
• Lack of storage of observations and scientific narrative with the test result means they cannot provide the context needed to interpret the result
• Gaps in critical information associated with projects, studies and daily runs and information essential to the completion of study results, for example, analytical instrument setup, method validation documentation, sample QC and system calibration records
• Isolation from other laboratory technologies – leaving data in a silo
• Often cannot replace paper-based lab notebooks because workflow design is very structured and cannot deal with the variable nature of data discovered in R&D organizations

Many of our BioPharmaceutical customers are finding that legacy LIMS and other common software solutions such as the Electronic Lab Notebook (ELN) which were designed for very specific purposes, lack the flexibility to accommodate the demands of modern BioPharma development. For further information on ELNs, read our article on What is an ELN?

Data has become one of the most important assets in the BioPharma industry and BioPharma processes, instruments and equipment generate massive amounts of digital information. Innovative companies are shifting their focus to be more data-centric, with digital workflows designed to create a persistent, dynamic data backbone throughout the BioPharma lifecycle.

This provides a solid foundation for analytics and enables insights to be shared across internal and external teams. This in turn accelerates process understanding and ensures product quality.

Want to learn more about why modern BioPharma development requires more than just LIMS and spreadsheets?

LIMS systems are not typically used in research but there are often cases where LIMS-like functionality such as sample tracking, registration and material management for critical reagents is desirable.

To discover what IDBS offers for Research, explore E-Workbook

Lab execution systems (LES) are sometimes used in preclinical development either in conjunction with, or instead of, a LIMS particularly to support sample/reagent preparation documentation and/or specific types of analysis for large molecules.

To discover what IDBS offers for Preclinical Development, explore Polar BioAnalysis

While sample tracking and request management are key requirements during process development, most LIMS systems aren’t flexible enough to support ad-hoc requests, especially in the early stages. Many teams still use Excel spreadsheets to manage requests and report results.

To discover what IDBS offers for Process Development, explore Polar BioProcess

LIMS is the standard for manufacturing quality control (QC) including batch release testing. However, if product quality data is not connected to process data as part of a digital data backbone, the ability to optimize and troubleshoot the current process and apply learnings to speed the development of new processes is limited.

To discover what IDBS offers for Manufacturing, explore Skyland PIMS

IDBS has a long history of helping BioPharma R&D and Manufacturing companies tackle their biggest challenges in research, process design, optimization, scale-up, technology transfer and commercial manufacturing. Our SaaS cloud platform solutions are all built around a persistent, dynamic data backbone model. This BioPharmaceutical process data backbone enables data capture, contextualization, visibility and insight across an entire process, or across multiple processes. This data backbone forms a foundation for future AI/ML modeling and simulation.

• Business visibility and insight are driven by integrated digital platforms (the data backbone) that combine workflow execution, preconfigured system and hardware integrations, contextualized data stores built on F.A.I.R principles and integrated analytics
• Pre-configured and customizable workflows and integrations improve time to value, unlock operational efficiencies and foster collaboration
• Accessible, high-quality, contextualized data significantly reduce time spent on QA and overcome reporting bottlenecks
• Data traceability, assured data integrity and industry-leading security and compliance reduce the time to create study reports, freeing up resources to run more studies per year whilst also easing the regulatory burden

1. Read the LabManager articles:
   • Four Reasons Why a Legacy System Approach Isn’t Suitable for Modern Biopharma Development
   • Can an ELN Be Used as a LIMS?
   2. Download our eBook Beyond the ELN vs. LIMS Myth