QAssure.ai
QAssure.ai from LTTS transforms QARA operations by combining AI and complementary digital technologies to simplify documentation, deliver intelligent insights, enhance post-market monitoring, and accelerate compliance - bringing unmatched speed, accuracy, and confidence to regulatory processes worldwide.
Beyond automation, QAssure.ai enables proactive risk identification, unified process governance, and seamless collaboration across quality, regulatory, clinical, and supplier teams - providing a connected, intelligence-driven QARA ecosystem.
What We Do
QAssure.ai brings together a complete suite of QARA capabilities through four integrated modules—AiCE, AiCH, Supplier Quality, DHF Automate, and Clinical Study—each designed to streamline regulatory workflows with AI-driven precision.
AiCE – Clinical Evaluation Intelligence
AiCE accelerates every stage of literature review, clinical evaluation, and post-market safety reporting through AI-enabled automation.
Key capabilities include:
- Literature Screening (LSR): Automated searches, deduplication, PRISMA support, relevance scoring, bias & quality assessments, summary generation, compliance artifacts, and audit-ready outputs.
- Clinical Evaluation Report (CER): Scope definition, evidence aggregation, benefit–risk analysis, standards alignment, template automation, reviewer workflows, regulatory readiness, and AI-powered report generation.
- CER Enhancements: Fine-tuning and customization of CER workflows based on device class and regulatory requirements.
- Periodic Safety Update Report (PSUR): Coding and classification, signal detection, trending & KPIs, narratives, dashboards, cross-system links, scheduling, and governance.
AiCH – Compliance & Complaints Handling
AiCH streamlines complaint processing and safety signal detection with an end-to-end workflow built for compliance accuracy and rapid closure.
Key capabilities include:
- Complaint Processing: Intake, triage, investigation summaries, GFE, IMDRF coding, and reportability checks.
- Signal Detection: Automated signal identification with embedded control charts and analytics.
Supplier Quality – CoC / CoA & Audit Compliance
This module strengthens incoming quality inspection, supplier governance, and compliance readiness through automated certificate verification and audit workflows.
Key capabilities include:
- Certificate Verification: CoC/CoA analysis, data trend monitoring, and automated validations.
- Supplier Quality (SQ) Audit: Audit management, supplier quality agreements, NC CAPA tracking, ASL gap analysis, supplier disengagement workflows, risk management, and PQM support.
- Contract Management: Automated change control management for supplier documentation.
DHF Automate – Design History File Automation
DHF Automate standardizes and digitizes document control, risk processes, regulatory submission, and change assessments across engineering and quality functions.
Key capabilities include:
- Gap Assessment & Remediation: Template migration, content comparison, and labeling data extraction & validation.
- Risk Management: FMEA and standards compliance automation.
- Regulatory Submission: Structured support for NDA and 510(k) packages.
- Lifecycle Impact Analysis (LCA): System integration across MBSE/ALM/PLM/QMS and automated change assessment and remediation.
Who We Serve
Medical Device OEMs seeking faster regulatory approvals
Pharma and Biotech companies managing complex quality workflows
Global manufacturers needing unified compliance and supplier management
Regulatory & QA Teams aiming to reduce manual effort and ensure accuracy
Key Capabilities
AI-Powered Evidence and Insights: Automated literature screening, signal detection, and intelligent document generation.
Unified QARA Workflows: Integrated processes across Clinical, Compliance, DHF, and Supplier Quality.
Smart Process Governance: Traceability, versioning, risk linkage, and change control across the lifecycle.
Configurable and Modular Architecture: Deploy modules independently or as a connected QARA suite.
Compliance-First Design: Built-in regulatory frameworks, templates, and audit-ready outputs.
Benefits
Accelerated regulatory submissions with faster, more accurate documentation.
Higher operational efficiency through reduced manual effort and automated reporting.
Cross-functional alignment across Clinical, QA, RA, and Supplier teams.
Seamless enterprise connectivity with QMS, ERP, PLM, and CRM ecosystems.
Consistent, audit-ready compliance across global regulatory bodies.
Scalable deployment tailored to each OEM’s maturity and workflow complexity.