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Issues & Change Control Management Software

Resolve issues, and manage change with less stress and more control.

Absolute control over every CAPA, Change, and Deviation—with data integrity baked in.

CC & Issues_ Workflow-1

Design your quality processes your way

Use our truly configurable workflows to define the exact steps, required fields, permissions, and signature points for your unique deviations, CAPAs, Change Controls, and more. No IT help required.

Categorize your workflows – and your data – to reflect how you actually operate

Structure workflows by Site, Location, Department, or Type (e.g., Temperature Excursion, Document Change, etc.). Then, use these categories to filter your data and spot patterns in deviations, CAPA cycle times, and more.

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CC & Issues_ Roles_Permissions

Protect data integrity with the right access

Set granular permissions that control who can view, edit, and approve documents or workflow stages by role, team, and location.

Features in the ZenQMS Issues and Change Control modules that Quality teams love:

  • Easily search and find any issue or change control
  • Keep an accurate record of change within your organization
  • Wide variety of custom fields to structure your data collection in an organized way
  • Build follow-up tasks directly into your process so change is actionable
  • Full, visible, searchable, and exportable
  • Audit Trail records that regulators understand
  • Built in due dates to keep your team on track
  • Assign detailed permissions for access and escalation
  • Automatically enforce closed-loop processes
  • Email notifications to alert your team of upcoming or past due items
  • Export any item to PDF
  • APIs to connect to your other systems

More ZenQMS Modules