SMART CAPA

Corrective and Preventive Action (CAPA) Management Software

Effective management of complaints, holds and deviations through root cause analysis to corrective and preventive action planning and implementation.

Digital CAPA Features

Features that automate CAPA process and drive continuous Improvements

CAPA Management

Digitize the corrective and preventive action process to manage process defects effectively.

Complaint Management

Streamline complaint management, identify sources, assign users for corrective actions and monitor the progress in real time.

Product Hold and Release

Manage product hold and disposal through proper investigation and reduce recurrence.

Deviations Management

One stop solutions for all types of deviations through root cause analysis and management.

Root Cause Analysis

Effective root cause analysis through brainstorming tools like 5 Whys and FishBone analysis.

Corrective Action Management

Assign corrective actions to internal or external users with a schedule for review and closure.

Dashboard

Track and monitor progress of deviations with customized dashboard and analytical reports.

Effectiveness Review

Review and manage effectiveness of corrective and preventive action planning based on the trend analysis.

Reporting & Trend Analysis

Generate custom reports for trend analysis of cause and sources of occurrence.

CAPA Management

Digitize the corrective and preventive action process to manage process defects effectively.

Complaint Management

Streamline complaint management, identify sources, assign users for corrective actions and monitor the progress in real time.

Product Hold and Release

Manage product hold and disposal through proper investigation and reduce recurrence.

Deviations Management

One stop solutions for all types of deviations through root cause analysis and management.

Root Cause Analysis

Effective root cause analysis through brainstorming tools like 5 Whys and FishBone analysis.

Corrective Action Management

Assign corrective actions to internal or external users with a schedule for review and closure.

Dashboard

Track and monitor progress of deviations with customized dashboard and analytical reports.

Effectiveness Review

Review and manage effectiveness of corrective and preventive action planning based on the trend analysis.

Reporting & Trend Analysis

Generate custom reports for trend analysis of cause and sources of occurrence.

Smart Features

With customized root cause analysis tools such as 5 Whys or fishbone Analysis, identify the source and cause of the problem for effective corrective and preventive action planning and closure of the same.

Visualize and manage the trends of non compliances along with the action planning status through customized dashboard presented in various graphical formats.

Use the power of Smart CAPA to identify, resolve, trend and prevent incidents in the process and improve non compliance gaps.

Identify and assign non compliance action items from the investigations to respective employees and review the completion based on the scheduled timeline.

Use the trend analysis tool to identify, correct and review outliers in the process. Set configurable indicators for trend watch and get notified in real time.

The notification capability lets the business configure when and how a user needs to be notified for which actions by email, sms, or through the in-app notifications when corrective or preventive action is assigned, to be reviewed or approved.

How Smart CAPA Works

Manage corrective and preventive actions effectively in ten easy steps

Effectiveness Review

Configure CAPA Layout

Populate CAPA Master Data

Create CAPA Process Flow

Record Creation

Conduct Investigation

Root Cause Analysis and Trace

Cost of Quality

Create Corrective Action and Preventive Action

Corrective Action and Preventive Action Management

Configure CAPA Layout

Customize the CAPA process management to align with organizational needs and regulatory requirements.

Populate CAPA Master Data

Input essential information into the CAPA system, including details about issues, stakeholders, and timelines.

Create CAPA Process Flow

Establish a step-by-step workflow outlining the sequence of actions required for effective CAPA management.

Record Creation

Generate comprehensive documentation of the issue or non-conformance triggering the CAPA process.

Conduct Investigation

Investigate the root causes and contributing factors associated with the identified issue or non-conformance.

Root Cause Analysis and Trace

Analyze the underlying causes of the problem and trace its origins within the system or processes.

Cost of Quality

Assess the financial impact of the issue on quality, including costs related to detection, prevention, and correction.

Create Corrective Action and Preventive Action

Develop specific measures to address the identified issue and prevent its recurrence.

Corrective Action and Preventive Action Management

Implement and oversee the execution of corrective and preventive actions, ensuring adherence to timelines and objectives.

Effectiveness Review

Evaluate the effectiveness of implemented actions through ongoing monitoring, data analysis, and feedback mechanisms.

Populate CAPA Master Data

Create CAPA Process Flow

Record Creation

Conduct Investigation

Root Cause Analysis and Trace

Cost of Quality

Create Corrective Action and Preventive Action

Corrective Action and Preventive Action Management

Effectiveness Review

Configure CAPA Layout

Corrective and Preventive Action (CAPA) Management Software

Digital CAPA Features

CAPA Management

Complaint Management

Product Hold and Release

Deviations Management

Root Cause Analysis

Corrective Action Management

Dashboard

Effectiveness Review

Reporting & Trend Analysis

CAPA Management

Complaint Management

Product Hold and Release

Deviations Management

Root Cause Analysis

Corrective Action Management

Dashboard

Effectiveness Review

Reporting & Trend Analysis

Smart Features

Root Cause Analysis

Dashboard

CAPA Management

Non Compliance Management

Trend Analysis

Notification

How Smart CAPA Works

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