Light Pharma QRM
Digital Quality Risk Management for Pharma
A centralized, collaborative platform that integrates every QRM tool you need — Process Flow, Cause & Effect, FMEA, Fishbone, Control Strategy — and turns risk assessments into a living knowledge base.
Quality Risk Management Should Be a Strategic Asset — Not a Spreadsheet
Vast amounts of risk knowledge are generated during development and commercial manufacturing — but critical product and process insights routinely get lost across teams, sites, mergers, and tech transfers. Manual risk assessments are resource-intensive, inconsistent across tools, and difficult to reuse.
Knowledge Lost Over Time
Tacit risk knowledge from past products and process changes is locked in individual heads, scattered spreadsheets, and abandoned shared drives.
Disconnected Tools
Cause & Effect, FMEA, and Fishbone studies live in separate files — when one changes, nothing else updates.
Resource-Intensive Reviews
Manual risk assessments consume weeks of cross-functional time and are prone to inconsistent scoring and missing documentation.
Hard to Track Mitigations
Action owners and due dates are buried in meeting minutes; overdue actions surface only at audit time.
Tech Transfer Friction
Site-to-site, M&A, and CMO transfers force teams to reconstruct risk knowledge from scratch.
Compliance Gaps
Inconsistent risk documentation creates exposure under ICH Q9 and 21 CFR Part 11 audits.
Light Pharma QRM — An Integrated Risk & Knowledge Platform
A state-of-the-art enterprise platform that consolidates every risk assessment tool into one synchronized workspace — and doubles as a living knowledge management system, making tacit insights from past projects accessible for reuse by other teams.
Centralized Risk Repository
Single, secure platform for historical risk data, FMEAs, mitigation plans, and real-time status across products and sites.
Integrated Risk Tools
PFD, C&E, Heat Maps, FMEA, Fishbone, Control Strategy — all synchronized so an update in one flows through to all related tools.
Knowledge Reuse
Make tacit knowledge from past products, transfers, and investigations searchable and reusable by other project teams.
Mitigation Tracking
Risk register and overdue action reports keep mitigation work visible and accountable in real time.
5 Capabilities — Everything You Need for Modern QRM
Centralized Risk Assessment Repository
Consolidates all risk management data on one secure platform. Centralized access to historical risk data, assessments, and mitigation plans, with real-time visibility into ongoing and completed risk assessments.
Structured Workflow & Integrated Tools
Process Flow Diagram, Cause & Effect Matrix, Heat Maps, FMEA, Fishbone Diagram, and Control Strategy — all synchronized. Update one tool and related tools update automatically. Applies to manufacturing and analytical method QRM.
Risk Register & Overdue Action Reports
Comprehensive risk register across Process, Method, Facility, and Equipment FMEAs. Track overdue actions in a consolidated report. Monitor mitigation implementation and update risk status in real time.
Customizable Reports & Dashboards
Generate audit-ready risk assessment reports in Word or PDF. Summarize key risk indicators with Heat Maps and KASA Control Strategies. Export risk management information for analysis or regulatory submissions.
Compliance & Data Security
Embedded e-signatures and audit trails for 21 CFR Part 11. Aligned with ICH Q10 principles of maintaining knowledge across the product lifecycle. Role-based access controls and secure storage of risk records.
Light Pharma QRM In Action
See how Light Pharma QRM brings every risk assessment tool, register, and report into a single guided workflow.
Built for the People Who Own Quality Risk
Head of Quality / QA
Cut review cycle times. Replace fragmented spreadsheets with one synchronized risk picture across products, methods, and sites.
MS&T / Process Engineers
Run FMEA, C&E, and Fishbone studies in one workspace. Pull historical risk knowledge from past products instead of starting from scratch.
Analytical / QC Leaders
Apply the same QRM tools to analytical methods — identify risks, set control strategies, and document compliance.
Compliance / RA
21 CFR Part 11 e-signatures, audit trails, and ICH Q9-aligned documentation — built in, not bolted on.
Aligned with Revised Schedule M (India)
India's Revised Schedule M (MSME deadline December 31, 2025) 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 QRM ReadinessFrequently Asked Questions
What is Quality Risk Management (QRM) in pharma?
QRM is a systematic process — described in ICH Q9 — for assessing, controlling, communicating, and reviewing risks to the quality of a drug product across its lifecycle. It uses tools like FMEA, Cause & Effect analysis, Process Flow Diagrams, Fishbone Diagrams, and Control Strategies to identify and mitigate risks to patients.
Which risk assessment tools does Light Pharma QRM support?
Process Flow Diagram (PFD), Cause & Effect Matrix (C&E), Heat Maps, FMEA (Failure Mode and Effect Analysis), Fishbone Diagram, and Control Strategy. All tools are synchronized — updating one (for example a C&E study) automatically updates related tools (Fishbone, FMEA).
Can it be used for analytical method risk assessments?
Yes. The same risk assessment tools apply to analytical methods — identify potential risks associated with methods, define controls, and document mitigation. Process and method QRM live in one workspace.
How does the knowledge management aspect work?
Light Pharma QRM captures tacit knowledge from each completed risk assessment and makes it searchable and reusable by other project teams. New product launches, tech transfers, M&A integrations, and site changes can draw on historical risk knowledge instead of starting from blank templates.
Is Light Pharma QRM 21 CFR Part 11 and ICH Q10 aligned?
Yes. The platform includes embedded e-signatures and audit trails for 21 CFR Part 11 compliance, role-based access controls, and secure storage and retrieval. Functionality is aligned with ICH Q10 principles for maintaining knowledge across the product lifecycle.
How does the risk register help with audits?
The risk register shows the highest risks and their current status across Process, Analytical, Equipment, and Facility FMEAs for selected products. Overdue actions are surfaced in a consolidated report, and risk status updates in real time as mitigations are implemented.
Ready to Digitize Your QRM Process?
See Light Pharma QRM in a 30-minute live demo. We will walk through your products, your tools, and your compliance requirements.