Quality Starts from Day 1
Start on the Right Foot.
Lexim Quantum™ is a unified, end-to-end platform built specifically for life sciences teams who need to manage quality, regulatory, compliance, and product lifecycle activities in a fast, reliable, and fully traceable way.
Designed as a modern alternative to fragmented legacy systems, Quantum brings together essential components like Regulatory Intelligence, Design Control, CAPA, Supplier Management, and more into a single, intuitive platform.
The Result: faster compliance, stronger audit readiness, and a dramatic reduction in operational overhead across the entire product lifecycle.
It’s never been easier to elevate your performance.
Why Lexim Quantum™?
80+
Regulatory intelligence covering standards for 80+ countries, fully compliant with QMSR, ISO, and global regulatory frameworks
10x
Processes that once took months now take
weeks → days → minutes
10x productivity increase via automation, AI document creation, and unified workflows
1
A single, ready-to-use solution purpose-built for life sciences teams, providing real-time insights for proactive decision-making and continuous improvement
Key Capabilities
A complete QMS designed for medical device, biotech, and pharmaceutical environments:
Document Control
Centralize, version, and manage all controlled documents with full traceability and regulatory compliance.
CAPA
Streamline corrective and preventive actions with structured workflows, root-cause analysis, and closed-loop tracking.
Training Management
Automate training assignments, tracking, and certifications to maintain workforce readiness and compliance.
Risk Management
Identify, assess, and mitigate risks through integrated, real-time risk controls aligned with global standards.
Design Control
Link requirements, design outputs, risks, and documentation in a fully traceable, audit-ready system.
Quality KPIs
Monitor quality performance with real-time dashboards that surface trends, gaps, and improvement opportunities.
AI-Powered Quality
Transform slow, manual quality tasks into instantly automated, compliant workflows
Generate Compliant
SOPs, Work Instructions,
and Controlled Docs
Automatically produce regulatory-aligned documentation using AI-generated templates and structured content.
Create and Automate
Training Programs
Instantly build role-based training curricula and automate delivery, reminders, and completion tracking.
Auto-Generate
Design Outputs and
Risk Documentation
Transform requirements into complete design outputs and risk artifacts with AI-driven drafting and mapping.
Identify Risks and Compliance Gaps
Instantly
Surface emerging risks, inconsistencies, and compliance issues in real time with
AI-powered analysis.
Accelerate Approvals with Smart Routing and
Workflow Automation
Shorten review cycles with automated routing, decision prompts, and intelligent workflow orchestration.
Problems Life Sciences Teams Face
Increasing global regulatory complexity
Heavy compliance burdens + documentation overload
Disconnected systems → poor cross-functional collaboration
Cost + margin pressure from inefficient workflows
Strict requirements for data integrity and traceability
Slow, manual CAPA, change control, and risk processes
Difficult, time-consuming submissions and post-market updates
How Lexim Quantum™ Solves These Challenges
AI Assistants for document creation, risk analysis, design outputs, and training programs
Automated discovery of relevant standards + regulations
Instant import and mapping of regulatory documents
Unified workflows for CAPA, change control, audit, and design control
Integrated submission support (including eSTAR)
End-to-end traceability from requirements to post-market surveillance