Quality CAPA Software

Correction Action CAPA Software

Corrective Action Preventive Action (CAPA)

Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

Improving quality and maintaining compliance depends upon robust CAPA management. The purpose of CAPA is twofold: to determine why quality events such as nonconformances and deviations have occurred, and to prevent them from happening again. By nature, CAPA processes span various quality systems and the data they produce. A digital and integrated CAPA solution allows companies to connect key quality channels and downstream processes throughout the entire product life cycle. The result is streamlined and thorough CAPA management for better product quality, safety and overall compliance.

MasterControl CAPA™

CAPA is the engine that drives quality. Does your system leverage it?


Stay Compliant With 21 CFR Part 11


Stay Compliant With 21 CFR Part 11

FDA 21 CFR Part 11 was released in 1997 as the industry moved toward the use of electronic systems, particularly for compliance-related activities. Today, digitization and automation are nearly ubiquitous, making the regulation more relevant than ever. Learn how MasterControl streamlines and automates GxP quality and business processes in a single connected and cloud-based platform.


Implement Closed-Loop CAPA


Implement Closed-Loop CAPA

The CAPA process is composed of many actions, data inputs, documents and more. A closed-loop CAPA methodology helps companies make sound quality decisions that lead to consistent outcomes, all while maintaining a complete, compliant and traceable audit trail.


Advance Beyond CAPA Toward Innovation


Advance Beyond CAPA Toward Innovation

As CAPA systems evolve and mature, many companies seek to advance beyond a safe and reliable CAPA program to one that allows more proactive and comprehensive quality event management. But striking a balance between traditional CAPA problem-solving approaches and innovative solutions is proving to be equal parts art and science.


Discover 7 Steps to Simplify CAPA


Discover 7 Steps to Simplify CAPA

A robust CAPA process consists of seven key actions that must be conducted and tracked. However, adequate documentation of these activities is often lacking. This white paper defines CAPA by breaking it down into its component parts and provides a simple step-by-step process for capturing, managing, tracking and trending essential CAPA actions.


Perform CAPA on Your CAPA System


Perform CAPA on Your CAPA System

A thorough CAPA process is necessary to help ensure product quality and safety, but not all companies are equipped with adequate systems and tools to properly execute it according to regulatory requirements. Learn how to assess your CAPA system and make the improvements needed to remain compliant.

What Makes an Industry-Leading CAPA System?


Automated Processes

MasterControl CAPA software digitizes and automates CAPA processes such as routing, notification, escalation and approvals to avoid bottlenecks and expedite issue resolution.


Integrated Quality

When CAPA is integrated with core quality management systems, automatic initiation of change control, training verification and task tracking ensure compliance with FDA 21 CFR Part 11 requirements.


Form-to-Form Launching

A fully digitized and automated CAPA system provides the ability to launch forms directly from customer complaints, deviations, nonconformances, audits, out of specifications and more.


Reporting Capabilities

With visibility into the entire CAPA process, you can analyze data and identify trends to help improve overall quality management.

Trusted By


The QMS Provider for the FDA

MasterControl and its partner, i4DM, have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. The two companies recently expanded their FDA project, serving as the QMS providers for a second FDA division, the Division of Pharmaceutical Analysis, which is part of the Center for Drug Evaluation and Research (CDER).


MasterControl CAPA: Fully Connected, Reliably Compliant

Corrective and preventive action is the single most critical element of any quality system, and must be managed as such to satisfy both FDA and ISO requirements. See how MasterControl CAPA software offers an easy-to-use, closed-loop solution for automating the CAPA process and integrating it with other quality processes for a holistic, connected and compliant approach to quality management.

Take control of your CAPA processes.

MasterControl software integrates CAPA processes with the entire product life cycle for a holistic approach to quality and CAPA management.

Get the Free Data Sheet | MasterControl CAPA™