Change Control Note (CCN)
Deviations
CAPA
Lab Incidents
OOS/OOT
Market Complaints
21 CFR Part 11 compliant
Facilitates cross functional teams assessment
Dynamic Report Generation
Risk Mitigation
We have built our modules in a way when used together they can communicate with each other seamlessly.
NLP and AI/ML capabilities map the previous quality events to provide recommendations on assessing the Change Control, Incidents and related Quality Events.
Integration with DocuZen™, EduZen™ and AuditZen™ applications.
Manages all quality related events, like: Change controls, Incidents, CAPAs, Market complaints, and OOS/OOT.
Facilitates end-to-end quality event workflow management and ensures that complete audit-trail is maintained.
Eliminates inefficient manual systems and ensures adherence to the prevailing c-GMP.
Ensures compliance with 21 CFR Part 11.
Reassignments & Extensions.
Integrated CAPA flow, Effective Checks.
We have built all the tools with unique Competitive feature you need to manage your important data