CAPA

ENSUR document control solutions grants you commanding flexibility when you find nonconformance, 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 control solutions 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 CAPAs to work instructions, procedures, training events, and specifications stored within the ENSUR repository.
  • 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, complaints, and investigations to CAPAs.
  • 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 CAPAs.
  • 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 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 process.
  • Out-of-the-box or build your own custom template CAPA management web-forms