CAPA Management Software to Optimize Quality and Compliance

What is CAPA?

Corrective and Preventive Actions, or CAPA, refers to the process of identifying, investigating, and rectifying issues to prevent their recurrence. Essentially, the CAPA process combines well-planned corrective actions to resolve non-conformances and preventive measures to prevent them from recurring. It includes the actions that are performed by regulated businesses both before and after the occurrence of a quality event.

As a key element of the quality management process, CAPA enables regulated businesses to proactively identify the root cause, accelerate issue resolution, ensure compliance with quality regulations, and facilitate continuous improvements.

CAPA Management Features in BizPortals QMS

BizPortals QMS allows users to quickly report, log, and track issues, including process deviation, incidents, non-conformances, and more in a centralized system and ensures that they are managed, resolved, and documented efficiently.

Cross-module integration facilitates holistic issue resolution by integrating workflows and data across different modules, such as audits, incidents, risks, and document control, improving the overall CAPA process flow.

From reports to audit trials and more, BizPortals QMS offers a centralized place to access all the CAPA documentation. Dedicated document control features like version control, track changes, and role-based permissions help maintain transparency and compliance.

Leverage automated workflows for document routing, approval, and email reminders to effortlessly streamline various CAPA stages to ensure consistency across the organization and speed up the overall quality process.

BizPortals QMS offers detailed activity logs to record issues and processes, interactive dashboards to identify trends and monitor progress, and data export features to ensure data visibility and facilitate sharing.

Easily configure CAPA workflow, define stakeholder’s roles, or create custom CAPA forms to capture essential details such as issue description, assessment details, root cause analysis, and corrective actions to streamline your quality improvement processes.

Effortlessly approve your CAPA documents with the e-signature feature offered by the BizPortals CAPA management solution. Simply draw and upload signatures or leverage Active Directory-based authentication for a detailed audit trail, enhanced transparency, and improved cost efficiency.

Issue Reporting and Tracking
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Cross-Module Integration
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Documentation and Record Management
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Automated Processes
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Data Visibility
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Configurable Processes and Forms
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Faster Approvals with E-Signature
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CAPA Management Process Flow: From Identification to Follow Up

Issue Logging

Reporting an issue is the first step that initiates the CAPA procedure. BizPortals CAPA management software offers a comprehensive form for issue logging. With customizable fields to enter basic information including the CAPA title, description, sources, and more, it allows users to add attachments for a clear record of the issue.

1

Risk Assessment

Once the issue has been logged, assessing its impact on the overall product or services is essential. Automated risk assessment forms, dedicated approval workflows with multiple approvers, and a detailed audit trail of activities can help users effectively collaborate in the risk assessment process.

2

Root Cause Investigation

Identifying the root cause is the next crucial step in preventing the recurrence of such issues. BizPortals CAPA management software, with robust document control and collaborative features, ensures that users have access to all the CAPA records, audit logs, and documentation ready for the root cause analysis.

3

Trend Analysis

Analyzing previous CAPA trends by studying detailed statistics and metrics helps outline more concrete corrective actions. BizPortals QMS's dedicated CAPA dashboard displays key metrics based on recurring issues, potential risks, and key categories like monthly trends, departments, stages, priority, etc., and helps businesses refine their processes.

4

Corrective Action Planning

A robust corrective action plan is necessary to address the issues based on the root cause assessment and an in-depth trend analysis. Here, automated review and approval workflow, centralized quality resources, and cross departmental collaboration offered by SharePoint-based CAPA management software can be game changers.

5

Implementing CAPA

Seamless execution and timely monitoring of the action plan decide the success of the overall corrective and preventive actions. This requires uninterrupted communication across departments, robust task management, progress tracking, and cross-module integration to ensure the plan is executed promptly and efficiently.

6 CAPA Management Process Flow: From Identification to Follow Up

1

Issue Logging

2

Risk Assessment

3

Root Cause Investigation

4

Trend Analysis

5

Corrective Action Planning

6

Implementing CAPA

Importance of CAPA in Quality Management System

Enhanced Quality

CAPA plays a crucial role in quality management by systematically addressing the underlying issues, reducing the overall defect rates, and achieving higher quality outcomes.

Regulatory Compliance

Regulatory bodies like the FDA, ISO, and industry-specific agencies mandate CAPA. Hence, implementing a well-planned CAPA facilitates smoother audits and inspections.

Risk Management

CAPA processes not only identify risks associated with the quality process but also facilitate proactive monitoring of potential risks causing disruption in quality operations.

Continuous Improvement

CAPA management software enables businesses to gather, analyze, and monitor trends associated with the issues, helping them identify key areas of improvement and process optimization.

Documentation and Traceability

Right from detecting issues to executing corrective and preventive actions, each stage is documented and records stakeholders’ actions, providing a clear audit trail for inspections.

Documentation and Traceability

Right from detecting issues to executing corrective and preventive actions, each stage is documented and records stakeholders’ actions, providing a clear audit trail for inspections.

CAPA Management Software

What is CAPA?

CAPA Management Features in BizPortals QMS

CAPA Management Process Flow: From Identification to Follow Up

Issue Logging

1

Risk Assessment

2

Root Cause Investigation

3

Trend Analysis

4

Corrective Action Planning

5

Implementing CAPA

6

CAPA Management Process Flow: From Identification to Follow Up

1

Issue Logging

2

Risk Assessment

3

Root Cause Investigation

4

Trend Analysis

5

Corrective Action Planning

6

Implementing CAPA

Importance of CAPA in Quality Management System

Enhanced Quality

Regulatory Compliance

Risk Management

Continuous Improvement

Documentation and Traceability

Documentation and Traceability

Other Dedicated Modules Offered by BizPortals QMS

Incident Management

Deviation Management

Document Control

Change Control

Form 1

Form