Optimize assessment and distribution of CMC Change Assessments


CMC Change Assessments

The current processes for dissemination of information pertaining to updates to CMC Change assessments is labor intensive, inconsistent, and rely upon the efforts and knowledge of individuals. The existing processes for dissemination of a change and tracking relies on manual processes including face to face meetings, e-mails and conference calls. This is highly inefficient and is prone to error resulting in business liability and risk. As the scale of operations grows, so grows the potential for reporting delays, errors, or loss of critical safety information. This, in turn, increases business liability and risk.

Quartica’s solution can play a key role in centralizing and streamlining the CMC Change Assessment processes from initial assessments to the local reporting requirements. The system provides support to assess changes by product and country and to track significant assessments.


Manage CMC changes from initial assessment to product and country specific assessments.
Facilitate regulatory compliance and conformance of CMC changes by prouduct and country reporting requirements.
Generate reports on receipt and regional conformance to a CMC changes.
Share knowledge easily and quickly between geographically dispersed groups.

Ready to automate your CMC Change Assessment process?


Key Features

  • Centralized notification and tracking of CMC change asessments
  • Notifications and time-boxed response tracking per change
  • Executive dashboard views and reporting of the notifications and responses
  • Role-based permissions and access control
  • Tracking of notifications, responses, and supporting documents
  • 21 CFR Compliant with built in audit trial, security and confidentiality protocols.