Last Updated on December 16, 2022 by Ossian Muscad
The manufacturing industry involves a lot of processes and procedures that need to be documented and tracked to ensure smooth operations and quality product outputs. A process validation report template is an important part of this process. It helps to document process validation activities and results, providing all the information needed to understand process performance systematically.
This article will discuss what a process validation report is, why it’s essential, and how to create one from scratch. That way, you will know just how essential this document is and how to make the process easier should you need to create a process validation report yourself.
What Is a Process Validation Report?
A process validation report is a document that describes process validations performed in the manufacturing process of a product. This document shows evidence that a manufacturing process can deliver quality products consistently. A process validation report provides official documentation of qualification protocols such as the following:
- Equipment qualification
- Operational qualification
- Installation qualification
- Performance qualification
A process validation report is generally executed and completed before the start of routine commercial production. Quality assurance managers and process engineers typically use process validation reports to ensure optimum process performance and product quality.
Why Is a Process Validation Report Important?
A process validation report is important because it ensures that the process used in manufacturing a product is effective and consistent. In addition, this document allows process engineers to review the process validation activities and compare the process performance with process specifications.
Without a process validation report, there can be no assurance that process outputs are consistent and of the required quality. That’s why process validation reports are essential tools in process engineering and product development.
Key Factors in Manufacturing Process Validation
“Process Validation: General Principles and Practices” by The US Food and Drug Administration (FDA) outlines the current process validation determinants, which include the following key factors:
- Design process review and process qualification– This ensures that process design is appropriate for the product and process.
- Process performance qualification– This evaluates process performance against process specifications.
- Continued process verification and process control– This verifies that process performance remains as expected throughout the process life-cycle.
- Process validation maintenance– This ensures process performance remains as specified over time.
What To Include in a Process Validation Report Template?
The first step in creating a process validation report template is determining what information should be included in the document. A process validation report generally consists of the following components:
- Purpose of process validation: This section outlines the process validation objectives and purpose.
- Process description: This section provides a detailed description of process steps, parameters, and controls.
- Validation process: This section outlines process validations, including equipment qualification, operational qualification, installation qualification, and performance qualification.
- Scope of process validation: This section outlines process validations that are done and process validations that are not done.
- Methodology used for process validation: This section outlines the process validation approach, process validation tests, process validation results, and process validation conclusion.
- Results of process validation: This should provide process validation results, process validation observations, process validation recommendations, and process validation conclusions.
- Conclusion and recommendations: This section outlines process validation conclusions and process validation recommendations.
- References: This section lists process validation references used in the process validation report template.
How to Create a Process Validation Report Template?
Now that you know the components of a process validation report, the next step is to create the process validation report template. Here are some steps to follow:
Step 1: Gather process validation information. Collect process validation information from process design documents, process specifications, process validation results, and process validations process control plans.
Step 2: Create a process validation report outline. Outline process validation objectives, process description, methodology, process validation results, and conclusion.
Step 3: Design process validation report template. Create process validation report format and process validation report sections, including the purpose of process control, process description, process evaluation, the scope of process control, methodology used for process control, and results of process control. Include references to relevant documents in the report template.
Step 4: Document process validation results. Include process validation results, process control observations, and process control recommendations in the process validation report template.
Step 5: Finalize the process validation report template. Review the process validation report template for accuracy and completeness before releasing the process validation report to stakeholders.
Create Process Validation Report Templates Using a Low-Code Platform
Paper-based templates are still a thing. But that doesn’t mean you should conform to them. With the advent of process automation, creating process validation report templates with a low-code platform is much more efficient and less time-consuming.
DATAMYTE is a robust quality management platform that offers low-code capabilities that let you quickly create process validation report templates. Its Digital Clipboard, in particular, is a low-code software that features an intelligent form builder. This tool can create comprehensive process validation report templates in a few clicks.
The process validation template you create using DATAMYTE can be easily deployed to all your process validation processes. Furthermore, you can use the process validation report template to monitor process validations and control process parameters in real-time.
With low-code features such as a drag-and-drop interface, process validation report templates become much easier to create. This process automation platform also enables you to manage process validations more effectively and efficiently, ensuring process validations are always carried out correctly.
Book a demo with us today to learn more about process validation report templates and process automation with DATAMYTE. Our dedicated team of process experts will guide you through the process step-by-step.
Conclusion
By following these steps, you can create a process validation report template that can be used to document process validations, process control results, and process control recommendations. A process validation report template is invaluable for providing process validation stakeholders with the information they need to make informed decisions about process performance and process controls.
