Enterprises Solutions

Quality Management System (QMS)

The Karomi QMS system consists of the following modules

  1. Document Control
  2. Audit Management
  3. Corrective and Preventive Action (CAPA)

Document Control

It Manages the creation, approval, distribution and archiving of all controlled documents in the organization.

The following features are included

  • Version control and document numbering system
  • Complete audit trail of all document operations
  • Central Repository for controlled documents
  • Document change request and change approval workflow process
  • Distribution list configuration for document circulation
  • Alerts and reminders on document approval

Audit Management

Audit Management streamlines the audit process by automating all recurring tasks, including scheduling of audits, sending out assignments, and tracking tasks. It integrates into the CAPA process and manages all deviations in one single traceable system.

Key Features
  • Configure and add checklist for any type of audit (Internal, Vendor, Customer, etc.)
  • Provides for a central master schedule of all audits.
  • Automatic audit plan assignments, once the audit plan is approved.
  • Tracks and alerts for upcoming and overdue audits.
  • Issue audit report including completed checklist and related action items.
  • Issue Corrective Action investigation based on audit findings.
  • Inherit audit data into Corrective action – dual link between audit and CAR.
  • Several built-in management reports on audit status and history
  • Built-in performance statistic report

Corrective and Preventive Action (CAPA)

CAPA are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. A typical CAPA process looks like this

Key Features
  • Define investigation activities and assignments.
  • Route investigation plan for review and approval
  • Relevant data is automatically inherited (Non-Conformance, Calibration, Audits, Complaints, etc.)
  • Dual link between investigation and source of issue
  • Automatically lookup and display related investigations
  • Initiate Corrective Action plan for confirmed investigations
  • Multiple reports are generated automatically providing an effective mechanism for tracking the source and cost of problems
  • Root-cause analysis using 5-Why technique
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