Quality Management System (QMS) Solutions - QualZen

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QualZen™

Quality Management System

AI enabled digital quality platform. Platform that

Reduces compliance risks
Manages missing due dates and follow-ups for quality incidents
Facilitates cross-functional team coordination
Records and manages event trends
Optimizes lack of control
Provides AI/ML enabled workforce accountability
Monitors quality of product through its entire lifecycle
Delivers excellence in quality in every organizational activity

Check out our QualZen™ Platform

Product Features

Quality Event Management

Manages all quality related events, like: Change controls, Incidents, CAPAs, Market complaints, and OOS/OOT.

Workflow Management

Facilitates end-to-end quality event workflow management and ensures that complete audit-trail is maintained.

Dynamic Dashboards

Provides dynamic dashboards which the management can use to visualize the ongoing, pending and completed quality events.

Faster Decision Making

Drives faster decision making and shorter time-to-market.

GMP Adherence

Eliminates inefficient manual systems and ensures adherence to the prevailing c-GMP.

Team Collaboration

Enables collaboration between cross-functional teams, including external stakeholders.

Automatic Notifications

Sends automatic notifications to marked individuals sends escalations in case of approaching due dates.

21 CFR PART 11 Compliance

Ensures compliance with 21 CFR PART 11.

How QualZen™ links with other ZenVector™ Products

QualZen™ integrates with DocuZen™ and EduZen™ to manage quality events seamlessly
If any change is implemented in SOP through a quality related event in QualZen™, the same will directly get linked with the EduZen™ module within the ZenVector™ platform, so that training can be provided to the workforce on the revised SOP
QualZen™ links with DocuZen™ to have all the quality events have the relevant SOP or document numbers mentioned within their records
If any quality event within QualZen™ requires a change to made to a document, the same gets automatically linked to DocuZen™ and the change can be implemented without ever getting out of the platform

Product Differentiators

Recommendations

NLP and AI/ML capabilities map the previous quality events to provide recommendations on assessing the Change Control, Incidents and related Quality Events.