Supporting Innovation: How LigoLab Empowers Labs to Develop and Validate Their LDTs

As laboratory-developed tests (LDTs) become increasingly essential to personalized medicine and cutting-edge diagnostics, medical labs are turning to technology partners that foster innovation while maintaining strict regulatory compliance.

LigoLab’s all-in-one laboratory information system (LIS) and lab revenue cycle management (lab RCM) platform stands out as a transformative pathology software solution because it enables labs to confidently design, validate, and manage their LDTs with agility. 

LigoLab’s advanced platform features fully configurable workflows, real-time analytics, and robust compliance tools, delivering the flexibility and laboratory information system functions needed to meet today’s complex testing and regulatory demands.

Join us as Jenny Bull, LigoLab’s Success Director, with 26 years of laboratory operations experience overseeing anatomic pathology, molecular, cytology, clinical, laboratory revenue cycle management (lab billing), human resources, quality, and finance, takes us on a detailed tour of the LigoLab platform and provides examples of how the best laboratory information system software supports tests developed and validated by an individual lab.  

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Custom Lab Workflow Configuration for LDTs

A core differentiator of LigoLab’s LIS system software is its ability to empower laboratory staff with complete autonomy in developing and managing LDT workflows. 

“LigoLab equips labs with user-friendly, fully configurable tools to create, modify, and manage assays independently," explains Bull. "This flexibility allows lab personnel to define workflows, build reflex and result logic, set quality control (QC) parameters, and customize report outputs without waiting on vendor assistance."

This independence accelerates the time-to-launch for new tests and allows laboratories to rapidly respond to evolving clinical needs or regulatory changes.

"LigoLab provides configurable tools that allow laboratories to design and adjust result formats, reflex testing logic, and validation workflows tailored to the specific needs of each LDT," Bull adds. "Dynamic result reporting and rule-based automation ensure accuracy and regulatory alignment."

For reproducibility and compliance, all test changes are tracked through a built-in version control feature and robust audit trails.

"LigoLab tracks every change made to test configurations, workflows, and reports," says Bull. "Each modification is logged with timestamps, user identification, and change details, ensuring transparency and accountability."

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Validation and QC Support

LDTs require rigorous validation to ensure clinical reliability and regulatory compliance. LigoLab supports this with custom validation protocols, automated data capture, and real-time analytics, all of which reduce manual entry and minimize errors.

With built-in tools for evaluating precision, linearity, and accuracy, a lab’s validation process becomes faster and more reliable.

"LigoLab allows laboratories to define and apply quality control (QC) rules specific to each test’s performance characteristics," Bull continues. "The LIS system actively monitors QC data in real time and automatically flags exceptions or out-of-range values."

This QC oversight is complemented by seamless data storage to support FDA submissions.

"The system ensures completeness, consistency, and traceability through a structured data architecture," notes Bull.

Learn More: A Detailed Look at How Modern Laboratory Information Systems Fully Support Quality Control

Integrated Reporting and Data Management

Clear, customizable reporting is crucial for communicating LDT results effectively. LigoLab’s dual reporting engines support narrative and structured formats with advanced logic capabilities.

"LigoLab’s dual reporting engines facilitate reflex testing logic, conditional formatting, and interpretive comments that enhance clinical value and readability," says Bull.

All test data, QC metrics, and validation documentation are centralized, making audits and reviews more efficient.

"This streamlined data management simplifies internal reviews by providing quick access to historical and real-time information," Bull explains. "It eliminates data silos, reducing errors and improving overall lab efficiency."

Real-time analytics also supports performance monitoring and troubleshooting.

"LigoLab’s real-time data analytics tools provide immediate visibility into lab operations," says Bull. "Dashboards and customizable reports help identify bottlenecks and initiate corrective actions promptly."

Learn More: Understanding the Importance of Real-Time Analytics in the Modern Clinical Laboratory

Compliance and Documentation

Navigating CLIA, CAP, COLA, TJC, and FDA requirements is no small task, but LigoLab assists with much of the compliance burden.

"LigoLab automates the collection, storage, and retrieval of key data required by accrediting agencies," says Bull. "This streamlining reduces manual errors and eases the weight of regulatory preparedness."

LigoLab’s all-in-one lab information system includes electronic signatures, audit logs, and role-based access to ensure data integrity and inspection readiness.

"The platform streamlines the entire qualification lifecycle by providing built-in tools and templates for DQ, OQ, and PQ," Bull notes.

During design qualification (DQ), users can trace test requirements. The operational qualification (OQ) phase leverages HL7 simulation and security checks, while the performance qualification (PQ) phase ensures readiness through real-world sample testing and system validations.

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Collaboration & Flexibility

LigoLab’s comprehensive and flexible medical LIS with embedded and advanced laboratory billing solutions enables a seamless workflow from test order to the RCM cycle, an essential consideration for complex LDTs.

"The platform tightly integrates technical operations with the laboratory billing process," explains Bull. "It ensures accurate charge capture and automatically applies the correct CPT codes and billing edits based on test type and payer requirements."

For multi-site laboratories and research institutions, LigoLab supports centralized pathology lab management and secure collaboration.

"Role-based access controls, secure internal messaging, and audit logging ensure operational integrity across distributed environments," says Bull. 

Learn More: Six Reasons Why You Should Choose an Integrated Laboratory Billing Solution for Your Medical Lab

LigoLab: Your Strategic Partner in LDT Innovation, Compliance, and Growth

By providing full control over LDT workflows, seamless validation tools, comprehensive reporting, and airtight compliance tracking, LigoLab empowers enterprising clinical labs and pathology groups to lead in innovation without compromising on quality or regulatory alignment.

"LigoLab is an innovation partner, equipping labs with the tools they need to meet today’s challenges and prepare for tomorrow’s opportunities," says Bull. 

For labs committed to advancing diagnostic science, LigoLab offers a strategic advantage that fuels growth, streamlines operations, and ensures compliance at every step.

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Powering Lab Efficiency, Compliance, and Growth with Unified LIS & RCM Software

LigoLab is a leading provider of integrated laboratory information systems (LIS) and lab revenue cycle management (lab RCM) software, built to streamline operations, reduce complexity, and increase profitability for medical laboratories. 

Since 2006, the company has delivered a comprehensive informatics platform that unifies all aspects of lab operations - from order entry and specimen processing to compliance, reporting, and billing - into one scalable solution.

Designed for clinical, reference, molecular, and anatomic pathology labs, the LigoLab platform empowers users with advanced automation, configurable workflows, and intelligent business tools that enhance speed, accuracy, and compliance. LigoLab enables labs to reduce errors, boost turnaround times, and maintain full regulatory alignment by eliminating siloed systems and manual workarounds. 

Backed by hands-on support and a commitment to continuous innovation, LigoLab has earned a reputation as a trusted technology partner for labs focused on delivering high-quality diagnostics and long-term success.

Ready to learn more?

Speak with a LigoLab Product Specialist!

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