Deviations & Complaints

Deviation Incident Investigation

When your product doesn’t meet your or your customer’s standards, you need to document why, investigate, and validate the reason for the deviation. Streamlining this process is an essential part of increasing company efficiency, reducing costs, and simplifying compliance.

With ENSUR Document Management, your company can take full control of your deviation and complaint process. The ability to collect, correlate, investigate, and make informed improvements can be electronically executed within ENSUR, granting you streamlined quality and control throughout your company.

Deviations and Complaints streamlined process


As a flexible, integrated Quality Management System (QMS), ENSUR enables you to configure the software to align with your processes. With the help of configurable workflows and web forms, every step of your process is tied together, from the moment a deviation or complaint is detected all the way through the investigation, correction, and follow-up. Don’t just manage deviations and complaints, tackle them head-on and work to avoid their recurrence.

ENSUR helps you turn deviation and complaint control into a means for continuous quality improvement:

  • Link incidents to work instructions, procedures, training events, and specifications stored within ENSUR
  • Collaborate on the definition and resolution of deviations and complaints
  • Allow users of ENSUR to enter incidents and generate Corrective Action Preventative Action requests by site, supplier, customer, product, and more using web forms
  • Assign Action Items to specific employees, departments, or teams
  • Upload and attach any file type to deviation/complaint incidents
  • Configurable, automated workflow that can be changed when needed
  • Automated email notifications to all parties involved in an incident
  • Comprehensive detailed audit trails on user actions, names, dates, and times of when 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 deviations/complaints
  • Out-of-the-box or build your own custom template web-forms

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