Light Pharma QRM
Digital Quality Risk Management for Pharma
A state-of-the-art enterprise platform that integrates every risk assessment tool you need - FMEA, Cause & Effect, PFD, Fishbone, Control Strategy - and doubles as a knowledge management system, making tacit knowledge from past projects accessible for reuse.
The Challenge in Pharmaceutical Manufacturing
Global Operations
Pharmaceutical R&D and manufacturing operations span multiple facilities worldwide. A vast amount of knowledge is generated during research, development, and commercial manufacturing - but critical product and process knowledge often gets lost within organizations over time.
Complex Requirements
Essential activities such as new product launches, mergers and acquisitions, regulatory changes, and cost optimization frequently necessitate transfer of knowledge and technology between locations. QRM is essential to ensure product quality, regulatory compliance, and patient safety - but manual risk assessments are resource-intensive and error-prone.
Why Choose Light Pharma QRM?
Centralized Platform
A collaborative platform with advanced analytics and customizable workflows to proactively manage risks while meeting international regulatory standards.
Knowledge Management
Serves as a knowledge management tool that enhances effectiveness and efficiency of knowledge transfers by making tacit knowledge and insights from past projects accessible for reuse.
Enterprise Solution
State-of-the-art enterprise software developed by Light Pharma to enhance and streamline the QRM process across your entire organization.
Centralized Risk Assessment Repository
Single Secure Platform
Consolidates all risk management data into one centralized location with secure access controls and real-time visibility.
Historical Data Access
Centralized access to historical risk data, assessments, and mitigation plans enables informed decision-making based on past experiences.
Real-Time Visibility
Monitor ongoing and completed risk assessments in real-time, ensuring teams stay aligned and informed throughout the process.
Structured Workflow & Collaboration
The QRM workflow ensures a seamless process from risk identification to mitigation - for both manufacturing and analytical method assessments.
Process Mapping
Create Process Flow Diagrams (PFD) to visualize workflows.
Risk Analysis
Utilize Cause & Effect Matrix, Heat Maps, and Fishbone Diagrams.
FMEA
Conduct Failure Mode and Effect Analysis and control strategies to summarize parameter information.
Configurable Workflows
Configurable risk assessment workflows and templates tailored to your organization's needs.
Light Pharma QRM In Action
Knowledge & Risk Tools Grid
PFD, Cause & Effect, FMEA, Fishbone, and Control Strategy - all in a single integrated workspace.
Visual Risk Mapping
Intuitive heat maps that make complex risk data immediately understandable to stakeholders.
Risk Matrix & Categories
Visualize risk levels by category and likelihood, with detailed drill-down.
Risk Register & Action Tracking
Comprehensive risk register across Process, Method, Facility, Equipment, and Generic FMEAs - with overdue actions surfaced in real time.
Leveraging Knowledge Across the Product Lifecycle
Capturing Knowledge
- Document critical insights during development
- Transfer knowledge between teams and facilities
- Preserve institutional expertise
Risk Assessments
- Conduct comprehensive risk evaluations
- Apply learnings from previous assessments
- Ensure consistent methodology
Quality Investigations
- Access historical data during investigations
- Identify root causes efficiently
- Implement corrective actions
Customizable Reports & Dashboards
Flexible Reporting
Generate detailed risk assessment reports in Word or PDF formats for audits and reviews with user-friendly, customizable templates.
Interactive Visualization
Visualize key risk indicators with interactive reports like Heat Maps and KASA (Knowledge-aided Assessment & Structured Assessments).
Data Export
Export risk data for further analysis or regulatory submissions, ensuring seamless integration with your quality processes.
Regulatory Compliance & Security
Fully compliance-ready to meet global regulatory frameworks, data integrity, and security at every level.
21 CFR Part 11 Compliance
Embedded e-signatures and comprehensive audit trails.
ICH Q10 Alignment
Functionality aligned with principles of maintaining knowledge across the product lifecycle.
Data Protection
Role-based access controls and secure storage for all risk-related records.
Flexible Configuration
Configure workflows and templates tailored to your organization's requirements with admin-level customizations.
Aligned with Revised Schedule M (India)
India's Revised Schedule M requires Pharmaceutical Quality Systems, Quality Risk Management, CAPA, and data integrity - aligned with WHO GMP and ICH Q9/Q10. Light Pharma QRM is built for these requirements out of the box.
Talk to Us About Schedule M ReadinessFrequently Asked Questions
What is QRM in pharma?
Quality Risk Management is a systematic process - described in ICH Q9 - for assessing, controlling, communicating, and reviewing risks to drug product quality across the lifecycle. Tools include FMEA, Cause & Effect, PFD, Fishbone, and Control Strategy.
Which risk tools does Light Pharma QRM support?
Process Flow Diagram (PFD), Cause & Effect Matrix (C&E), Heat Maps, FMEA, Fishbone Diagram, and Control Strategy - all integrated so updates flow through automatically.
Can it be used for analytical method risk?
Yes. The same risk assessment tools apply to analytical methods. Process and method QRM live in one workspace.
How does knowledge management work?
Light Pharma QRM captures tacit knowledge from each completed risk assessment and makes it searchable and reusable. New product launches, tech transfers, M&A, and site changes draw on historical risk knowledge instead of starting from blank templates.
Is it ICH Q10 and 21 CFR Part 11 aligned?
Yes. Embedded e-signatures, comprehensive audit trails, role-based access controls, and secure storage. Functionality aligned with ICH Q10 principles for knowledge management across the product lifecycle.
What does the risk register do?
Shows the highest risks and their current status across Process, Analytical, Equipment, Facility, and Generic FMEAs. Overdue actions are surfaced in a consolidated report, and risk status updates in real time as mitigations are implemented.
Ready to See It in Action?
Book a 30-minute live demo. We will walk through your data, your workflow, and your compliance requirements - whatever matters most to your team.
Or copy our address: support@lightpharma.com · we usually reply within one business day.