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 delivers an integrated, AI‑powered QARA suite that connects clinical evaluation, signal detection, supplier quality, and DHF automation into a single, governed ecosystem.
Designed for regulated environments, each module works independently or as part of an end‑to‑end lifecycle platform- enabling faster decisions, continuous audit readiness, and predictive compliance without compromising regulatory integrity.
Clinical Evaluation Intelligence
- Automated Literature Screening (LSR): AI‑driven search, deduplication, PRISMA‑aligned screening, relevance scoring, and quality assessment with audit‑ready artifacts.
- AI‑Powered CER Automation: Scope definition, evidence aggregation, benefit–risk analysis, standards alignment, reviewer workflows, and submission‑ready CER generation.
- Regulation‑Aware Configuration: CER workflows tailored by device class and regional regulatory requirements.
- Integrated PSUR & Safety Reporting: Classification, signal detection, trend analysis, KPIs, narratives, and governed reporting.
- Human‑in‑the‑Loop Validation: Medical and regulatory experts validate AI outputs at key decision points.
- Workflow‑Driven Execution: Configurable orchestration from protocol definition to final, compliant outputs.
Signal Detection
- AI‑Assisted Intake & Triage
Standardized complaint intake, triage, and categorization with structured investigation summaries. - RPA + AI Decision Support
RPA automates repetitive steps, while AI guides judgment‑intensive decisions such as classification, problem code prediction, and next‑best actions. - Regulatory‑Ready Coding & Reportability
Built‑in IMDRF‑aligned coding, reportability checks, and compliance decision support. - Guided Investigations & RCA/CAPA
Decision‑tree driven investigations enabling consistent root cause analysis, CAPA initiation, and corrective action workflows. - Submission‑Ready Outputs
Structured, regulator‑aligned documentation supporting vigilance/MDR and FDA‑style reporting expectations. - Operational Dashboards & Visibility
Interactive dashboards providing insight into trends, bottlenecks, and emerging quality signals for faster action.
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.