CAPA Management

What is CAPA? CAPA is a concept within Good Manufacturing Practice (GMP) and numerous ISO business standards. It focuses on the systematic investigation of the root causes of identified problems or risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).

Xybion’s eQCM-XD™ is a comprehensive quality management software solution that enables integrated CAPA management. eQCM-XD provides a comprehensive Corrective and Preventive Actions workflow as part of its enterprise quality management solution. The CAPA solution is integrated to all other core quality management processes. Corrective and Preventive Action (CAPA) is one of the most daunting tasks of any quality-minded organization. FDA, ISO, EMEA, and other regulations and standards mandate a systematic approach to managing Corrective and Preventive Actions.

While all organization’s hope to avoid the root causes that necessitate corrective actions, reality dictates otherwise. Because defects, deviations, or other gaps that trigger the need for a CAPA can come from a myriad of sources (documents, training, products, etc.), CAPA management has become the core process of a well-established compliance and quality program.

The CAPA software module is an integral part of the eQCM-XD quality management suite. It may be used as a stand-alone module or integrated with other processes such as nonconformances, audits, training, complaints, and others. The eQCM-XD CAPA management module allows organizations to create a single configurable workflow to handle the entire lifecycle of the CAPA from the triggers that can auto-launch the corrective action to the final sign-off. If your company prefers, multiple workflows can also be developed without vendor or IT support. CAPA methodology is meant to manifest product and process improvements.

The Xybion eQCM-XD Suite delivers a comprehensive platform for GRC and quality management. Our solution includes embedded best practices and flexibility for deployment in any system environments. eQCM-XD is seamlessly integrated with standard enterprise technologies including Microsoft, Oracle, Documentum, and others to ensure compatibility with most systems environments.

Key Features:

  • Enterprise Platform as a Service
  • On-Premise, SaaS Deployment Options
  • Advanced Integrated Technologies
  • Flexible Process Control Engine
  • Compliant with current Regulatory Guidelines
  • Compatible with OCEG GRC Framework ensures Sustained Compliance and Governance

Other Modules

AUDIT MANAGEMENT

QUALITY MANAGEMENT REPORTING

INTERNAL CONTROLS

COMPLAINT MANAGEMENT

IT GOVERNANCE

NONCONFORMANCES

INCIDENT MANAGEMENT

DOCUMENT MANAGEMENT

LEARNING MANAGEMENT

CHANGE MANAGEMENT

PROGRAMS AND OBJECTIVES