CAPA Solutions

CAPA Corrective Action and Preventative Action

ENSUR document control solution grants you commanding flexibility when you find non-conformance reports, accidents, incidents, supplier issues, and customer complaints with your products or production processes. The ability to collect, correlate, investigate, and make informed improvements can be electronically executed within ENSUR. Now you have streamlined quality and control throughout your manufacturing process.

The ENSUR document management software provides you a configurable, comprehensive anytime, anywhere Corrective Action Preventative Action (CAPA) tracking. The web forms help guide business and quality people to fully identify, record, define, investigate and correct any nonconformance found. The configurable workflow allows companies to monitor the solution from draft through effective implementation and verification of your corrective action/preventative action.

If you have any doubt whether you will meet your compliance objectives for ISO, cGxP, OSHA, SQF, FDA 21 CFR Parts 11, 211, and 820, ENSUR takes away the concern.

Authoritative Features of ENSUR’s CAPA quality control capabilities:

  • Link incidents and CAPA to work instructions, procedures, training events, and specifications stored within the ENSUR
  • Collaborate on the definition and resolution of Corrective and Preventative Actions
  • Allow users of ENSUR to enter incidents and generate Corrective Action Preventative Action requests by site, supplier, customer, product, and more using web forms
  • Associate multiple incidents and investigations to CAPA with a complaint management system
  • Collaborate on Root Cause Analysis and developing appropriate Action Plans in Corrective Action or Preventative Action Requests
  • Assign Action Items to specific employees, departments, or teams.
  • Upload and attach any file type to incidents and CAPA
  • Configurable, automated workflow that can be changed when needed
  • Automated email notifications to all parties involved in an incident and/or CAPA
  • Comprehensive detailed audit trails on user actions, names, dates, and times of when CAPAs or support incidents have been created, reviewed, analyzed, implemented, modified, verified, deferred, and closed
  • Generate reports and export data to track trends, measure improvements, and analyze your Corrective Action and Preventative Action
  • Out-of-the-box or build your own custom template CAPA solutions web-forms
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