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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.

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.

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.

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 six easy steps

1. Configure Template

Select the information you want on your record from the customizable complaints, deviations, holds, and CAPA templates.

2. Create record

User creates appropriate deviation record from the configured complaints, deviations, holds, and CAPA templates

3. Conduct root cause analysis

Investigate the root cause of deviations through root cause analysis tools like 5 Whys or FishBone Analysis

4. Corrective and preventive actions

Identify Corrective and Preventive Actions as required to address the root cause of deviation.

5. Assign user and due date

Assign the actions to appropriate internal or external users along with the due date

6. Verify Effectiveness

Ensure the effectiveness of the corrective and preventive actions through the review process

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

How Smart CAPA Works

Manage corrective and preventive actions effectively in ten easy steps

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.

FAQ

Frequently Asked Questions

What is CAPA Software ?

CAPA Software stands for Corrective And Preventive Action Software . CAPA is a system to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

What are the benefits of using a CAPA software?

Proper investigation to the root cause of process deviations can help in eliminating the process defects and improve food safety or quality compliances.

How to Assign a Corrective Action to a User?

Once the root cause is identified, create corrective and preventive actions to be assigned to the respective user along with a due date.

What is the 5 Whys Root Cause Analysis methodology?

In 5 Whys methodology, we ask the why question again and again to find the real cause of the incidents.

What is Smart CAPA?

Smart CAPA digitalises the deviation management process for efficient and effective management of the root cause and actions to close the same.

What kind of deviations I can create with Smart CAPA?

Users can create Customer Complaint records, Hold and Release Records, Process Deviation Records and CAPA records with Smart CAPA.

What Root Cause Analysis tools the software supports?

The Smart CAPA software supports the 5 Why’s and Fishbone diagram analysis tools.

Can I create an Out of Specification in Smart CAPA?

Yes you can create Out-of-Specification to verify if the test results are meeting with the expected results.

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