SpeedsPath Glossary of Terms

Validation

In pathology lab management software, Validation refers to the systematic process of verifying and documenting that a system, instrument interface, assay, or workflow configuration consistently performs as intended and produces accurate, reliable, and reproducible results. Validation ensures compliance with regulatory standards such as CLIA, CAP, and NABL.

What Is Validation?

Validation is the systematic process of verifying and documenting that a system, instrument interface, assay, or workflow configuration in pathology lab management software consistently performs as intended and produces accurate, reliable, and reproducible results. It ensures compliance with regulatory standards such as CLIA, CAP, and NABL.

Why Validation Matters in Pathology Labs?

Validation is critical for ensuring the accuracy, reliability, and consistency of lab processes.

Key reasons include:

• Ensures the software or workflow performs according to defined requirements.
• Confirms accuracy, reliability, and consistency of lab processes.
• Required before launching new instruments, tests, interfaces, or major LIS updates.
• Documents that all system outputs match expected clinical and operational results.
• Prevents analytical errors, reporting issues, and regulatory non-compliance.
• Covers functional validation, technical validation, and user acceptance testing (UAT).
• Involves testing real-world scenarios and sample data sets.
• Must be traceable with logs, reports, and signed approval documentation.
• Part of quality assurance and necessary for accreditation audits.
• Critical for patient safety and data integrity in pathology labs.

How Validation Works in a Laboratory Information System (LIS)?

In a modern LIS like SpeedsPath, validation becomes seamless and efficient. The system supports testing workflows, captures validation data, links to regulatory standards, and establishes a digital chain of documentation. Thanks to this automation, manual errors are minimized, and each validation record remains accurate from setup through to final approval.

Key Steps or Components of Validation

• Defining validation requirements and protocols
• Performing functional and technical testing
• Executing user acceptance testing (UAT)
• Documenting results with logs and reports
• Obtaining signed approvals
• Ensuring traceability and compliance

Benefits of Using LIS for Validation

• Streamlined testing and documentation processes
• Automated logging and reporting
• Improved compliance with CLIA, CAP, and NABL standards
• Reduced manual effort and errors
• Enhanced quality assurance and audit readiness

Common Challenges Without LIS Automation

• Manual testing errors and incomplete documentation
• Difficulty maintaining traceability
• Poor compliance leading to regulatory issues
• Delays in validation processes
• Increased risk of patient safety concerns

Examples of Validation in Pathology

• Validating a new instrument interface for hematology tests
• Testing workflow configurations for histopathology
• Verifying assay performance in molecular diagnostics

SpeedsPath Makes Validation Accurate & Effortless

Validation is central to ensuring reliable results in pathology labs. Accurate verification, documentation, and compliance make test outcomes trustworthy. Automating this step with an LIS adds precision, efficiency, and regulatory adherence.

See how SpeedsPath supports validation, tracks documentation, and streamlines compliance.

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Related Terms

• Quality Assurance
• User Acceptance Testing (UAT)
• Regulatory Compliance
• Traceability
• Accreditation

FAQs

1. Why is validation required in pathology lab software?
   Validation ensures that the software performs accurately and reliably, meeting regulatory requirements and ensuring patient safety.
2. When should a lab perform validation?
   Before software go-live, after major system updates, when adding interfaces, or when introducing new tests or workflows.
3. Who is responsible for performing validation?
   Typically the QA/QC team, laboratory director, LIS administrator, or designated validation specialists.
4. What types of validation are common in pathology labs?
   Functional validation, technical validation, instrument/LIS interface validation, performance verification, and UAT.
5. How long does the validation process usually take?
   Depending on system complexity, it may take from a few hours (for small changes) to several weeks (for new LIS implementations).
6. What documents are required for validation?
   Test scripts, validation plans, expected vs. actual results, deviation logs, approval signatures, and final validation reports.
7. Does validation need real patient data?
   Most validations use sample, dummy, or de-identified data to maintain PHI compliance.
8. How does validation help in regulatory compliance?
   It demonstrates that the lab follows CLIA/CAP/NABL standards and maintains quality and traceability.
9. Can validation be automated in lab software?
   Some LIS platforms offer automated test execution, data comparison, and logging, but human review is still required.
10. What happens if a system is not validated properly?
    It can lead to incorrect lab results, workflow failure, audit issues, accreditation penalties, and potential patient risk.

Want to learn more? Explore our LIS Glossary or check out our expert blogs on Anatomic Pathology, Molecular Diagnostics, Cytology, and Lab Information Systems.