Enhance Risk Management by identifying, assessing, and mitigating quality risks. Stay proactive, make smarter decisions, and ensure compliance.
Enhance Risk Management by identifying, assessing, and mitigating quality risks. Stay proactive, make smarter decisions, and ensure compliance.
In life sciences, Risk Management isn’t a nice-to-have, it’s a regulatory expectation. Whether you’re managing a product launch, supplier change, or deviation investigation, every decision needs to factor in risk.
Risk Management is the process of identifying, evaluating, controlling, and monitoring risks that impact product quality, patient safety, or regulatory compliance. With Quality Forward’s eQMS, your risk data is centralized, actionable, and directly connected to your quality processes.
Spot potential risks during product development, manufacturing, and across your supply chain.
Apply proven methodologies like FMEA, RPN, HACCP, or custom scoring to assess risk consistently.
Link risks to CAPAs, change controls, and other quality workflows for full traceability and context.
Support global expectations with alignment to ICH Q9, ISO 14971, FDA, EMA, and GxP standards.
Use built-in templates for FMEA, hazard analysis, and other life sciences methodologies
Document and track risks across your organization - from lab to manufacturing
Turn risk into a continuous improvement tool - not just a compliance task
Get a real-time view of risk levels by site, process, or product
Link risks to audits, CAPAs, deviations, change control, and more
Built to support ISO 14971, ICH Q9, FDA expectations, and global regulatory guidelines
Customize scoring methods, workflows, and templates without IT support
Support teams of any size – from R&D startups to global manufacturers
Built for FDA, EMA, ISO, and GxP-regulated life sciences companies
Get alerts on trending risks, overdue reviews, and potential compliance gaps
Modern infrastructure with the security, speed, and reliability you expect
Meet ICH Q9, ISO 14971, and 21 CFR Part 11 requirements with full traceability
Record risks from any QMS process or project with structured templates
Use consistent scoring for impact, likelihood, and detectability
Define actions to reduce or eliminate risks - and assign owners and deadlines
Schedule periodic reviews and track the effectiveness of your mitigation strategies
Automatically associate risks with related deviations, CAPAs, or audits
View heatmaps, trends, and high-risk areas to support decision-making
