Frequently Asked Questions

A laboratory information management system (LIMS) is specialized software that performs sample management, lot management, testing protocols, and release of products and materials, and can also facilitate project management, experiments, stability testing, standards and reagents management, and instrument calibration and periodic maintenance.

Among many other things, a LIMS provides sample management and tracking, results reporting, scheduling, certificate of analysis/certificate of conformance generation, inventory and laboratory workflow management, regulatory compliance, quality assurance and control, reporting, and label/barcode generation. 

The cost of a LIMS will vary depending on the level of customization and the number of other systems with which the LIMS will interface. Additional costs include initial validation, the number of licenses required, and infrastructure.

If your staff spends a significant portion of their time on manual results entry, sample tracking, and reporting, and these manual processes are beginning to produce errors that necessitate rework, then yes, your lab will probably benefit from a LIMS.

If your organization lacks experienced LIMS users or your IT support lacks LIMS implementation expertise, hiring a third-party LIMS selection expert is the best way to make an informed choice. Due to the high cost of implementation and the significant business impact, a LIMS selection engagement with experienced consultants will save you money, time, and effort, and greatly assist in selecting the best LIMS for your organization. 

All LIMS implementation projects have different time frames. Factors that affect the LIMS implementation timeframe are how ready the client is to have the implementation begin, the organizational preparation for the change, number of labs and locations, the amount of configuration vs customization needed, the availability and onboarding of client resources, how the legacy data is migrated, the number of systems or instruments that need to be integrated, and whether the system needs to be validated.

A project plan will be provided by your LIMS Project Leader before implementation begins, outlining the steps your team can expect. User requirements, governance, change management, and manufacturing/operations use of the LIMS are also taken into consideration. Then, the build/configuration takes place along with master data and use case configuration. Next is the testing phase (functional, user acceptance) and master data load. The implementation phase includes system training, SOP preparation and training, and then the final master data load. Lastly, go-live occurs with training and hyper care support as needed.

A LIMS can interface with manufacturing resource planning (MRP) or enterprise resource planning (ERP) systems, chromatography data systems (CDSs), balances and many other types of laboratory instruments, and Periodic Maintenance and Calibration systems. LIMS interfaces to electronic data management systems (EDMSs) and quality management systems (QMSs) can also be quite beneficial.

Knowing whether you need a LIMS, ELN, or LES will depend on the needs of your unique laboratory. A LIMS is typically used in a manufacturing or quality control environment, an ELN is frequently chosen for research and development settings, and an LES is found most commonly in Quality Control. Request this webinar to dig deeper and learn what additional information will help guide your selection.

A scientific data platform (SDP) is an integrated, centralized ecosystem that collects, harmonizes, governs, and enables advanced analysis of all scientific data from instruments, LIMS, ELNs, and other systems. It accelerates discovery while ensuring data integrity and streamlining your laboratory’s compliance. SDPs exist to eliminate data silos by acting as a centralized hub for harmonized data that can flow seamlessly between those systems and instruments.

An SDMS is a data storage system, a sophisticated archive for your lab’s data. An SDMS is focused on the capture, organization, storage, and retrieval of scientific data. In contrast, an SDP is an end-to-end ecosystem for managing, analyzing, and ultimately deriving value from scientific data. You can read more about the SDMS and SDP differences here.

It’s possible that the better question is, “how should AI not be used in the lab?,” because of the many ways in which AI is transforming lab operations to enable predictive modeling and smarter reporting. To learn more about potential use cases and common misconceptions, listen to this podcast episode, What You Need to Know About AI in the Lab.

A LIMS will pay for itself within 18 months to 2 years, depending on what functionality is built into it at the onset. However, putting the forecasted return on investment (ROI) into a format to win over the decision maker is the hard part. To help, CSols has outlined documentation you should provide in our blog about how to justify a LIMS. If you need additional help presenting this information, CSols can team up with you. We want your lab to implement a LIMS successfully just as much as you do!

Return on investment can be calculated by taking the actual savings in terms of analyst man-hours saved looking for data and testing transcription, increased lab throughput, and cost of quality from lab errors, etc., from an implementation. These are just some examples; many more can be found.

Securing stakeholder buy-in involves a combination of effective project leadership, communication, and organizational change management to clearly demonstrate the potential value of the informatics project and help everyone involved to understand what improvements, benefits, and organizational synergies will result. 

The answer will vary based on organizational size; however, the following organizational contributors generally are required: one or more representatives from stakeholders, IT, quality, lab(s) subject matter experts (SMEs), manufacturing unit(s) SMEs (if applicable), and project management. If Agile methodology scrums are used, the organization should provide a product owner, scrum master, development team, and, again, stakeholders.

Yes, it can be done and is being done currently by many large and small organizations. The keys are leadership, having the right team members, and using the right communication tools. You might even save some travel costs by doing a LIMS implementation remotely.

The organization will provide the implementation team with proper scoping, requirements, and a lead from the business [product owner(s)]. CSols will translate the requirements into actionable user stories; create workflows; and ultimately develop, test, train you on, and deliver your system. Specialized laboratory informatics consultants add value to complex projects in many ways.

Yes, absolutely. You purchased it, it’s your software, and therefore, it’s your decision who you want to work on it. CSols routinely performs LabWare implementation and validation work for several industries.

LIMS configuration is taking the commercial off-the-shelf (COTS) software and modifying (configuring) it to meet your needs. LIMS customization is required when there are gaps in the COTS software that will require changes or additions to the base code to meet the organization’s requirements.  It’s important to know the difference between customization and configuration before starting your LIMS implementation.

If you want to have the utmost security and control over your data, on premises is the best choice. A cloud-based solution can eliminate the cost of maintaining and running IT infrastructure, yet provide data security and storage. Both options can work; the choice of which is a matter of organizational preference.

Yes. A LIMS in a cloud environment like Amazon Web Services (AWS) can certainly be validated using existing tools. The key is understanding the infrastructure of the cloud-based platform and validating the LIMS to current good manufacturing practices (GMP) standards for security, data integrity, and U.S. Code of Federal Regulations (CFR) part 11 requirements.

Passing an FDA audit is not difficult if you audit yourself internally, or use a third-party auditor, to a risk assessment level typically one tier above the current level of FDA inspection. Then remediate the gaps found using define, measure, analyze, improve, and control (DMAIC) or a similar process.

Modern LIMS have advanced search and presentation capabilities to enhance critical data-driven decision making. Intuitive user-definable dashboards display meaningful data in tables and graphs for instant oversight of laboratory activities and results.

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