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CAPA Report

Use CAPA methodology using digital checklists to identify and eliminate regulatory and organisational deviations early on.

CAPA Report Template

Identify, address, and prevent the occurrence of regulatory and organizational non-conformance with this CAPA report template.

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Risk Management Plan Template

Use this risk management plan template to identify the risks and register the risks' impact on a project.

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5 Whys Template

Use this 5 Whys template to determine the root cause of a problem so that your business teams can prevent encountering them again.

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What is a CAPA report?

The CAPA (Corrective and Preventive Action) serves to identify regulatory as well as organizational deviations. It includes an identification of the problem as well as the precise evaluation and implementation of solutions and corrective actions. Compliance officers use a CAPA report form to comprehensively document a summary of the problem solution.

The following topics are covered in this article:

1. The 7 steps of the CAPA report

2. Lumiform: Your digital tool for CAPA reports

The 7 steps of the CAPA report

An effective CAPA report helps companies work efficiently and reduce the risk of errors and non-compliance with laws. The following 7 steps are based on the defined FDA regulations regarding the CAPA report:

  1. Analyze - The Capa process begins with a comprehensive analysis and documentation of all existing data. These should be evaluated to identify the root cause of a problem.

  2. Examine - A plan for identifying the problem must be worked out, preferably with a responsible person to identify the basic problem.

  3. Identify - Finally, the problem should be precisely identified and defined. The evaluated data should support the identification.

  4. Verify - Possible corrective actions should be evaluated and thoroughly checked for their suitability. It is important that they do not have any negative effects on the end product.

  5. Implement - The measures and any other changes must be implemented and documented in order to monitor the progress of the implementation of solutions.

  6. Guarantee - Those responsible for combating the problem should have all possible information on quality gaps in order to guarantee the quality and safety of the product in its entirety.

  7. Submit - All data collected in the report, including quality issues and solutions, should be presented to the management team to enable them to evaluate the changes.

Lumiform: Your mobile app for the CAPA method

With Lumiform's mobile app, you can easily conduct any kind of quality and safety inspection via tablet or smartphone - online or offline. With the desktop software, you can create checklists and evaluate the data collected in the field. This significantly reduces the risk of quality loss, accidents at work, documentation errors and damage to reputation.

Digitize checklists and internal processes with Lumiform:

  • The flexible checklist builder from Lumiform helps you to convert any individual paper list into a digital checklist without much effort.

  • In addition, we offer more than 9,000 ready-made templates to help companies get started digitally in no time.

  • Using the super intuitive mobile App, you and your teammates conduct check in the field with ease and in no time.

  • All results, images and comments are automatically bundled in a digital report.

  • Comprehensive analyses help you to identify inefficient areas in your company more quickly and thus to continuously improve your auditing and inspection processes.

Your contact for all questions concerning CAPA Report

You have questions or would like to schedule a personal demo? We are happy to help you!