Diagnostics
Diagnostics teams need LIMS/ELN validation, IVDR clinical performance evidence, and data-integrity discipline. Cybroscape delivers all three, plus AI validation for algorithm-driven assays.
Diagnostics laboratories are concerned less with application software than with analytical instruments. These are classified by USP <1058> group and qualified accordingly — design qualification, installation and operational checks against calibrated references, and performance runs where the group requires them — with the LIMS and any chromatography data system validated alongside.
Identify The Roadblocks Slowing Your Growth
These challenges compound: cycles slow, scaling gets harder, and inspection posture drifts.
Regulations We Cover
Every diagnostics engagement is mapped to the regulations your inspectors will use.
labs
- EU IVDR
- FDA 21 CFR Part 809 / 11
- CLIA / CAP
- ISO 15189
- 01Assay developmentELNLIMSDevelopment records behind the claims
- 02Performance studiesEDCLIMSPerformance evidence for IVDR
- 03ManufacturingMESERPLot records and release
- 04Lab operationsLIMSInstrument middlewareISO 15189 and CLIA records
- 05Post-marketComplaint handlingPerformance follow-upComplaints and performance over time
Services & Products For Diagnostics
- GxP CopilotAI-native, CSA-first computer system validation for Life Sciences.
- TraceDraftSource-traceable drafting and analysis of clinical and regulatory documents.
- Cybroscape eQMSAn agentic quality management system for pharma, biotech and medical devices.
- Study IntelligenceAgentic intelligence across your studies — samples, biomarker data, operations and vendors in one place.
LIMS validation for a hospital-integrated diagnostics lab
A hospital-integrated diagnostics lab had accumulated data-integrity findings across three inspections.
Read the case studyEU IVDR Clinical Performance Evidence: The Transition Reality
EU IVDR enforcement has fundamentally changed the clinical evidence requirement for in vitro diagnostic devices placed on the European market. Under IVDR Annex XIII, Class C and Class D IVDs require clinical performance studies or a clinical performance evaluation based on scientific validity data and analytical performance data. For many established diagnostics products that held CE-IVD marks under IVDD, the existing clinical data package is insufficient under IVDR standards — creating a substantial evidence gap that must be filled before the applicable transition deadline.
TraceDraft supports the clinical performance evaluation documentation that IVDR Annex XIII requires: the scientific validity assessment, the analytical performance evaluation, and the clinical performance study report. For laboratories seeking to support their IVDs with peer-reviewed literature, TraceDraft's systematic search capability and structured evidence synthesis tools reduce the documentation effort while maintaining the traceability that IVDR notified bodies require. Where new clinical performance studies are needed, TraceDraft supports the study report documentation from protocol through final report.
Laboratory Developed Test (LDT) Validation Under FDA Oversight
FDA's finalised LDT rule (2024) brings most laboratory developed tests under FDA oversight as medical devices, creating a regulatory compliance obligation that most clinical and reference laboratories have not previously faced. LDTs previously operated under CLIA/CAP oversight for analytical validation, without device registration and without the predicate-based 510(k) or PMA pathway requirements that apply to commercially manufactured IVDs. Under the LDT rule's phased implementation, higher-risk LDTs will need to meet 21 CFR Part 820 quality system requirements and either 510(k) clearance or PMA approval.
The implications for LIMS validation in clinical laboratories are significant: a LIMS that manages LDT data under FDA oversight is now subject to 21 CFR Part 11 requirements for electronic records. Laboratory information systems that were previously validated only against CLIA/ISO 15189 standards for analytical quality need to be assessed against Part 11 requirements for audit trail completeness, access control, and electronic signature components. Our diagnostics practice helps clinical laboratories navigate this transition, assessing existing LIMS deployments against the new regulatory framework and developing remediation plans that address the gaps.
AI-Driven Assay Validation: Algorithm Governance in Diagnostics
AI and machine learning algorithms are increasingly embedded in diagnostic assay interpretation — from digital pathology AI that classifies cellular morphology to molecular diagnostics AI that interprets complex multi-analyte signature patterns. These algorithm-driven interpretations are not merely software features: in the context of an FDA-cleared IVD or an EU IVDR CE-marked device, the algorithm is part of the device's intended use and therefore subject to both the original clearance/CE-marking requirements and the change control obligations that apply to approved devices.
Algorithm-driven assay validation requires a specialised framework that addresses the probabilistic nature of AI outputs within the deterministic evidence requirements of IVD regulation. Our AI validation practice for diagnostics covers: algorithm performance benchmarking against a representative sample set; bias assessment across demographic subgroups; drift monitoring for algorithm performance over time; and a documented change control process for algorithm updates that satisfies both FDA SaMD guidance and EU IVDR post-market surveillance requirements. GxP Copilot provides the ongoing monitoring infrastructure that keeps algorithm performance documented between formal validation events.
Explore More For Regulated Life Sciences
Diagnostics validation without the backlog.
Bring one system. A diagnostics validation lead shows you the package it produces.
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