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Custom Laboratory Information Management System
Integrations, Development Steps, Costs
Since 2005 in healthcare IT, ScienceSoft builds robust, regulatory-compliant solutions for managing and automating operations of medical labs, including hospital, clinical research, biotech, R&D, and other labs.
A laboratory information management system is needed to centralize laboratory data, streamline testing workflows, and optimize lab operations such as sample tracking, QA/QC management, inventory and equipment monitoring, regulatory reporting, and more.
Note: most often, LIMS solutions support research workflows and have sample-centered capabilities, while LIS software (laboratory information system) is for patient-focused processes. However, the borders between the two are not strict and LIMS can be used both in research and clinical environments.
A custom LIMS is an optimal choice for organizations that need to accommodate unique sample handling procedures (e.g., for rare disease diagnostics, genetic testing), cover diverse lab operations, integrate LIMS with multiple enterprise systems and instruments, and provide role-specific workflows. A custom solution is also a way to implement advanced ML/AI-driven features such as automated test result interpretation.
- Implementation time: 6 to 18+ months.
- Common integrations: ERP, EHR/EMR, CRM, electronic laboratory notebook (ELN), laboratory instruments, molecular diagnostic platforms, a quality management system (QMS).
- Costs: $100,000–$800,000+, depending on the solution's complexity. Answer a few questions about your business needs to get a custom quote from our consultants.
42% of Organizations Bet on LIMS to Modernize Lab Operations
According to the Digital Lab of the Future, almost half of respondents are planning to implement or upgrade a LIMS to digitize lab processes and future-proof laboratory information management.
Capabilities of a Laboratory Information Management System
Core features
Sample management
LIMS allows users (e.g., lab managers, QS team) to create and automatically route test orders to the relevant departments and locations. Samples and sample batches can be tracked in real time from their receipt to disposal to support integrity and a proper chain of custody. Advanced LIMS solutions have capabilities for barcode labeling to replace manually assigned unique identifiers (e.g., a number, alphanumeric code).
Workflow management
It is possible to create automated workflows that guide lab technitians through standard operating procedures (SOPs) . Each step can be assigned required or expected inputs needed to proceed to the next step. Other ways to control the created workflows include notifications on deviations, checklists, and prompts.
Integration with internal and external systems
LIMS should seamlessly exchange data with other software (e.g., EHR, ELN) using data exchange standads like HL7 (for clinical data) and DICOM (for imaging data). For example, it can get access to EHR patient data to facilitate the screening of candidacte eligibility for clinical trials or streamline the sharing of experiment results with ELN.
Interoperability with lab instruments
LIMS solutions can support ASTM data exchange standards and enable automated entry and recording of test results from lab instruments (e.g., spectrometers and chromatographs) and molecular diagnostic platforms (e.g., PCR, NSG). Advanced systems can support bi-directional interfacing (sending requests and commands from LIMS to the equipment).
QA/QC management
A LIMS with QA/QS capabilities allows users to set test-specific validation criteria based on laboratory standards, regulatory requirements, and internal protocols and track non-compliance incidents. More advanced solutions can automatically compare QC criteria and actual test sample data to flag anomalies and send instant notifications to the user (e.g., ML/AI-powered alerts on sample contamination or data entry errors).
Supply chain and inventory management
A LIMS can monitor the availability and use-by dates of reagents, glassware, surgical masks, and other inventory, send shortage and expiration alerts, and enable automated reordering. Such solutions can also track order status from placement to delivery and help evaluate supplier performance. Advanced solutions also feature capabilities for demand forecasting and what-if modeling (e.g., to simulate procurement strategies and choose optimal ones).
Equipment management
LIMS solutions track item-specific details (e.g., model, serial number, responsible personnel), status, performance, and maintenance and calibration schedules to let labs conduct predictive maintenance, achieve optimal operating conditions, and optimize equipment lifespan.
Security management
LIMS solutions safeguard sensitive data through data validation checks, data masking and encryption, role-based access, and other security mechanisms to ensure complete data security in line with personal data protection regulations like HIPAA and GDPR.
Environment monitoring
LIMS can use data from temperature, humidity, and other sensors to continuously monitor the lab environment (e.g., in clean rooms, freezers, incubators). A system can automatically log environment data for further reporting and generate deviation alerts to enable quick corrective measures.
Waste management
LIMS helps to classify wastes according to regulatory standards such as EPA and OSHA and automatically label waste containers with info on their contents, hazard level, and handling instructions. Labs can also track waste container quantities, types, and storage locations and assign disposal methods (e.g., incineration, recycling). Such systems can be integrated with solutions from waste disposal vendors to facilitate the scheduling of waste pickups.
LIMS helps track metrics like turnaround time, revenue and cost per test, mean and standard deviation of QC results and represent them in interactive dashboards with capabilities for drilling up and down, slicing and dicing. Advanced systems can also enable ML/AI-powered predictive analytics (e.g., to forecast test utilization) and automated interpretation of test results.
Document management
LIMS can act as a centralized repository of all lab documents (protocols, test methods) and has version control capabilities toF help track changes. Such solutions allow for template-based report creation and automated document generation (e.g., lab reports, CoAs). There are also capabilities for document linking, collaborative document editing, e-signatures, and info search based on keywords, tags, and metadata.
Complementary features
Service and billing management
LIMS solutions allow labs to create service catalogs with descriptions, pricing, and turnaround times. It is also possible to streamline payment management by automatically generating quotes and invoices and enabling payment processing through integrated payment gateways.
Customer portals
Such portals allow customers to browse lab catalogs, request services, track order status, and get real-time notifications (e.g., on order completion or delay). Users can check lab results and pay for the provided services right in the portal. Labs can also use customer portals to gather feedback and improve service delivery accordingly.
Staff training management
LIMS stores personnel competency and training records, giving a 360-degree view of staff qualifications and allowing managers to track employees' professional development over time. Such solutions can also feature capabilities for training creation and completion progress monitoring.
Core Integrations for a Laboratory Information Management System
The exact list of integrations for a LIMS depends on the lab’s existing IT ecosystem and the capabilities a company wants to implement. Below, we have outlined the most essential integrations.
- Business systems (e.g., an ERP, billing and financial management software, inventory and asset management software) — to enable automated inventory replenishment; to support accurate billing; to provide data for predictive equipment maintenance.
- Customer data systems (e.g., EHR/EMR, CRM, customer portals) — to get access to patient data (e.g., for eligigbility checks during clinical trials; to facilitate communication with customers and personalize their experience.
- Electronic laboratory notebook (ELN) — to maintain a comprehensive history of samples and research data related to them; to facilitate collaboration between operational and research teams; to preserve transparency and traceability of scientific documentation for regulatory purposes.
- Laboratory instruments (e.g., HPLC, GC-MS, LC-MS) + molecular diagnostic platforms (e.g., PCR, NSG) — to automatically transfer test results to LIMS; to facilitate the interpretation of genetic and molecular test results; to enable predictive instrument maintenance.
- A quality management system (QMS) — to identify out-of-specification results; to streamline the implementation of the corrective measures.
- Payment gateways — to streamline payment processes.
Key Steps for LIMS Development
LIMS development is optimal when an organization needs to accommodate complex IT landscape consisting of disparate, often legacy systems. Custom development is also viable when an institution requires highly specific laboratory information management software in terms of functional and integration capabilities, role-specific workflows, regulatory and security requirements, and more. With 19 years of experience in custom healthcare software development, ScienceSoft shares key steps for successful LIMS implementation.
1.
Business analysis and requirement engineering
At this step, business analysts communicate with the lab’s management and target LIMS users (lab managers, technicians, researchers) to elicit the requirements for the solution-to-be. The experts review the software systems the organization already has and determine what laboratory operations should be facilitated via LIMS. They list the potential solution users, their responsibilities, needs, and challenges. At this stage, it is also planned how the systems will ensure compliance with the required regulations, e.g., personal data protection mechanisms for HIPAA and GDPR, quality control checks and staff training management for GCP and PIC/S.
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2.
Integrations and architecture design
During this stage, solution architects decide on optimal data sources to integrate with LIMS and plan API development accordingly. The architecture design team also plans the architectural components and chooses an optimal tech stack to support the workflows outlined during the business analysis.
The integration of lab instruments is often done via middleware – a software layer that acts as an intermediary between the instruments and LIMS. Such an approach is one of the ways to optimize project time and costs: middleware helps centralize data management and integrate instruments of different manufacturers and with various communication protocols according to the same pattern.
3.
Security framework design
The implementation of security controls like multi-factor authentication and role-based access control (RBAC), data encryption at rest and in transit, data validation mechanisms (e.g., checksums or hashing to verify data integrity), and more are planned at this stage. The specialists also plan audit trail mechanisms that will maintain immutable records of all modifications and transactions within a LIMS. For example, they identify key events to be logged (e.g., user logins, record creation, access to sensitive information), define a structured format for audit logs (e.g., fields like timestamp, user ID, affected data, action type), and decide on immutable storage options that prevent tampering (e.g., write-once storage or blockchain technologies).
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4.
UX/UI design
UX designers create solution workflows tailored to specific user roles. For example, lab technicians are likely to benefit from visual representation of sample status (e.g., as Kanban boards, Gantt charts) with an opportunity to navigate to sample details right from the relevant bar. Lab managers may appreciate no-code capabilities for creating new workflows by dragging and dropping widgets with procedure-specific tasks, relevant steps, operating procedures, etc.
To facilitate user adoption of the solution-to-be, UI designers can audit the existing software and reuse familiar elements and colors.
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5.
Development and testing
In most cases, developers and testers work in parallel, which makes it possible to identify and fix issues early on and minimize them in production. Other best practices for development optimization include DevOps implementation, feasible QA automation, and the use of off-the-shelf third-party components (e.g., for data orchestration and storage). In ScienceSoft’s projects, such an approach has helped cut development costs by up to 78%.
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6.
Deployment and support
The experts integrate the solution with the chosen data sources (e.g., ELN, QMS, EHR/EMR) and monitor system performance to identify and fix remaining issues, if any. The specialists also provide LIMS users with comprehensive software documentation (e.g., maintenance guides) to ensure smooth software maintenance and evolution.
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How Much Does It Cost to Develop a Custom LIMS?
The cost of custom LIMS development may range from $100,000 to $800,000+. The major cost factors include the range of lab operations to be covered by the system, the presence of real-time techs, and the need for complementary elements like a customer portal and a billing system.
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Basic |
Medium |
Advanced |
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The scope of lab operations covered by the system
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Sample management features, e.g., status tracking, batch processing, protocol and workflow management. |
Sample management + inventory management (e.g., inventory tracking, automated reordering). |
Sample management + inventory and equipment management + quality management + supply chain management + lab environment monitoring. |
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Integration with enterprise systems
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1-2 core systems, e.g., EHR/EMR and ERP. |
3-4 systems, e.g., ELN, data analytics tools. |
5+ systems, e.g., QMS, CTMS. |
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Real-time capabilities
?
Notifications on sample status updates, QC issues, equipment failures. |
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Barcode labelling
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A customer portal
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A customer portal covering up to 5,000 users. |
A customer portal covering more than 5,000 users. |
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Integrated billing system
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Analytics complexity
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KPI monitoring and BI reporting. |
Rule-based and ML/AI-powered forecasts (e.g., of turnaround time, staffing needs). |
Automated test results interpretation. |
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Cost
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$100,000–$150,000 |
$150,000–$300,000 |
$300,000–$800,000+ |
Why Choose ScienceSoft as Your LIMS Development Partner?
- Since 2005 in healthcare IT with 150+ satisfied customers.
- Experience in building solutions compliant with HIPAA, GDPR, GCP, and other regulatory standards.
- Since 1989 in AI and machine learning to automate processes and enable complex laboratory analytics.
- Proficiency in healthcare data exchange standards, including HL7, DICOM, ASTM, and more.
- ISO 9001-certified quality management and ISO 27001-certified information security management.
- #1 in Healthcare Software Development according to the Black Book™ 2023 market survey.
What makes ScienceSoft different
We achieve project success no matter what
ScienceSoft does not pass mere project administration off as project management, which, unfortunately, often happens on the market. We practice real project management, achieving project success for our clients no matter what.