Non-Conformance Management Software

Non-Conformance Management Software

Recording and managing non-conformances is an important element of any quality management system. It ensures that mistakes and deviations from specifications are identified and corrected.

isoTracker’s cloud-based Non-Conformance Management software ensures simple, fast, effective non-conformance management. Workflows automate processes so nothing is overlooked, and real-time visibility and analytics enable informed decisions and proactive responses.

Using the isoTracker Non-Conformance Management module, you can:

  • record and track non-conformances using a centralized, cloud-based platform
  • assign individuals to evaluate and investigate problems and give automated notifications and reminders
  • record required corrective and preventive actions (CAPA), assign CAPA requests to users, and close the requests once they’ve been met
  • use workflows to ensure nothing is overlooked
  • access up-to-date analysis of non-conformances and CAPA trends

The Non-Conformance Management module can be used as a standalone product. Alternatively, it can integrate seamlessly with the CAPA features in our Complaints Management, Audit Management, and Training modules.

Why consider our Non-Conformance Management software?

  • Full integration with CAPA features at no extra cost
  • Simplifies non-conformance management, ensures consistency, and prevents errors
  • Provides real-time data and analytics
  • Facilitates proactive responses, preventing future non-conformances
  • Drives continuous improvement, reduces costs, and increases customer loyalty

Platform for recording and managing non-conformances

  • Centrally identify and document a non-conformance or reuse one created in another QMS module
  • Use custom fields to capture information that your business needs
  • Assign responsibility for resolving each non-conformance to a particular individual
  • Evaluate and review non-conformances and use automated investigation task notifications
  • Ensure no step is missed by using an intuitive, logical workflow to automate processes

Record corrective and preventive action (CAPA) requests

  • Identify the action required to correct a problem, record the action taken, and verify its effectiveness
  • Assign CAPA requests to individuals or groups and use automated, time-based reminders
  • Provide proof by attaching documents, emails and/or pictures to CAPA requests
  • Ensure corrective action requests are closed only once the actions have been implemented and checked for effectiveness

Reassign responsibility

  • Reassign responsibility for managing non-conformances when necessary, to ensure optimal resolution
  • Reactivate closed non-conformances if the issues reappear

Advanced analytics and reporting

  • Analyze historical data to spot trends and common origins, and determine corrective measures
  • Simplify failure investigations, root cause analysis, and identification of areas for improvement
  • Use advanced reporting features to keep senior management and other stakeholders informed

Focus on prevention

  • Identify issues early and correct them
  • Use notification features to identify root causes and areas for improvement
  • Keep investigation and CAPA processes on track with automated alerts and notifications
  • Focus on doing things right the first time

Streamline compliance

  • Simplify and centralize recordkeeping
  • Ensure accurate, consistent recording of non-conformances
  • Accelerate non-conformance investigations, reviews, and approvals, as well as CAPA management, through streamlined, automated workflows
  • Keep resolution processes on track with a workflow-based system and automated reminders
  • Customize the software to suit your organization’s compliance processes

Reduced cost of quality

  • Resolve issues at the source so they don’t reoccur
  • Speed up the non-conformance resolution process
  • Make employees part of the system by demonstrating that all issues, including theirs, are being dealt with

Reduce regulatory and product risk

  • Use analytics and reporting to demonstrate efficient issue identification and correction
  • Easily identify “who, what, and when” for all actions
  • Involve your entire organization – from senior management to production and customer-facing teams – in the process

with a 60-day free trial

Our clients say

"...important to maintain tight control over policies in a dynamic and intense clinical environment... becomes simple when documents are managed by reliable, very easy-to-use and well supported software, such as isoTracker."

Flax Bourton Public Mortuary, Bristol, UK