RISK MANAGEMENTManage risk across the total product lifecycle
Seamlessly assess, prevent, and control risks to maintain compliance and build trust with patients and customers.
Build risk control into product design and development
Implement automatic ISO 14971 and FMEA compliance into your design controls
Improve the quality, safety, and effectiveness of your products
Ensure your quality and product teams are on the same page about risk strategy
Identify, prevent, and mitigate risks and vulnerabilities
Centralize risk identification, monitoring, prevention, and mitigation in a single source of truth
Define acceptable and unacceptable risks and apply these criteria across your organization
Employ an exportable risk matrix that details each hazard, situation, and harm, and calculates an initial risk score and mitigated risk score
Easily link to CAPA, internal audits, and customer complaints and feedback
Make stress-free audits possible
Demonstrate comprehensive risk control during external audits
Show traceability to related design controls and components
Stay compliant from premarket to postmarket
Explore other Enzyme eQMS modules
Suppliers
Simplify your supplier management process
Audits
Plan, conduct, and track your audits with ease
Complaints
Meet your postmarket surveillance requirements efficiently and effectively
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
