It is 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.
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.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.