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No validation vendor can guarantee compliance—compliance depends on how the system gets used, not just the software itself. Scispot Validation Care provides complete, audit-ready documentation and evidence that your LIMS was properly qualified. Your standard operating procedures, user training, and operational practices complete the compliance picture. Together, these elements create a defensible validation package for regulatory inspections.
Retest frequency depends on change impact and system criticality. High-risk changes affecting data integrity or regulatory compliance trigger immediate regression testing. Low-risk configuration updates receive documented change impact assessments. Routine retests run monthly for critical functions and quarterly for standard operations based on your laboratory's risk assessment.
Both laboratory information systems are supported. If you operate a clinical diagnostic lab under CLIA or ISO 15189, we tune OQ and PQ testing to clinical workflows and patient result reporting requirements. For research LIMS under GxP, qualification focuses on sample tracking, analytical workflows, and electronic laboratory notebook integration.
Your team provides the intended use statement, representative laboratory data for Performance Qualification testing, current standard operating procedures, and access to subject matter experts who understand your workflows. These inputs ensure validation testing reflects actual laboratory operations.
Complete LIMS validation includes validation plan, User Requirements Specification, risk assessment, Installation Qualification, Operational Qualification, Performance Qualification, and final validation report. Additional elements include traceability matrices linking requirements to test cases, change control procedures, and ongoing periodic review processes.
LIMS validation protects data integrity, ensures regulatory compliance, and prevents costly audit failures. Validated systems provide documented evidence that laboratory data is accurate, reliable, and traceable—critical for defending research findings, supporting regulatory submissions, and maintaining laboratory accreditation.
