Nonconformances

Continuous Process Improvement and Governance

It’s critical to have an effective strategy for nonconformances and to develop Corrective and Preventive Actions (CAPAs) to prevent repeat occurrences. The CQRM XD Nonconformance management software module allows you to effectively automate and manage the full nonconformance process in compliance with regulatory guidelines.

This module provides management of nonconformances through automated, web-based tools for managing materials, processes, components and products. Whether your organization manages defects, deviations, out-of-spec results or other types of issues, the CQRM XD Nonconformance module can replicate your workflow, recording, record keeping and reporting needs.

Manage Non-Conformances and Reduce Risks

Manufacturers across multiple industries must comply with guidelines such as cGMP, 21 CFR Part 820, ISO 9001, ISO 13485 and ISO 14001 which all include requirements for the management of nonconformances.

These global regulatory requirements include mandates to deal with products or raw materials that do not conform to product quality requirements.

With CQRM XD, you can mitigate risks of nonconforming products or materials that can lead to costly rework and even product recall. With the right software, you can reduce nonconformities and decrease your organization’s risk of adverse impacts to business continuity, customer relations and market reputation.

Key Features:

  • Effortlessly initiate and manage issues and corrective actions
  • Consistently follow best practices to initiate an IT change request
  • Risk-based approach to assess change impacts
  • Create action plans
  • Obtain appropriate approvals and sign-offs
  • Provide communication and collaboration throughout all stages of change cycle
  • View status of current processes, identify bottlenecks and review critical indicators to optimize process performance

Achieve Total Compliance with CQRM XD Quality Management Modules

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