Published: May 21, 2025  Updated: May 16, 2025

Process Validation and Verification in QMS: Definitions, Importance, and Implementation

This article will delve into two critical components of quality management systems (QMS). We'll look at process validation and process verification. Read on for further details about:

• What Is Process Validation and Verification?
• Why Process Validation and Verification Matter in a QMS.
• Challenges in Implementation and How to Overcome Them.
• Key Types of Process Validation Methods.
• Stages of Process Validation.
• The Role of a CMMS in Process Validation and Verification.

What Is Process Validation and Verification?

Consider process verification like double-checking your recipe before baking a cake. You confirm that the steps you plan to take to make the cake align with the desired outcome–a delicious dessert.

Use this "checklist" for various projects or even maintenance jobs in your company. Once again, you confirm—verify—that a process fulfills specific requirements. This involves examining and evaluating the jobs, materials, methods, and even those performing the jobs to ensure the proper outcome.

On the other hand, look at process validation as baking the cake multiple times and tasting it each time, so it consistently tastes great. Here, you confirm that the job, materials, methods, etc. from above produce consistent quality results. Quality checks. Put simply, you prove that your every component actually works as intended.

Why Process Validation and Verification Matter in a QMS

The easy answer: Businesses want quality and consistency. Think about the pharmaceutical industry. A company has to produce a medication to exacting standards. Every time. In this instance, the company thinks about safety and efficacy.

Process verification ensures the manufacturing steps align with the drug's formulation. Validation guarantees the process consistently produces the desired medication.

Let's use another example. In the food industry, verification confirms the accuracy of the recipe for a new ice cream flavor. Validation ensures that the production process consistently creates ice cream with the correct taste, texture, and nutritional content.

Let's review some other benefits.

• Enhanced product quality. With both validation and verification showing accuracy and consistency, you have higher-quality products.
• Improved customer satisfaction. Consistent product quality leads to happier customers. In the automotive industry, for instance, reliable vehicles built through validated processes enhance customer loyalty.
• Reduced risk. Identifying and addressing process issues early on can prevent costly recalls and reputational damage. For example, in the aerospace industry, where safety tops the list, rigorous validation helps prevent catastrophic failures.
• Regulatory compliance. Many industries have strict regulations. You use validation and verification to demonstrate compliance. In the pharmaceutical and biotech sectors, adherence to Good Manufacturing Practices (GMP) necessitates comprehensive validation programs.
• Increased efficiency. Optimized processes can lead to improved productivity and cost savings. In the chemical industry, validated processes can reduce waste, energy consumption, and production time.

Discover how streamlined maintenance processes can elevate production. Learn more.

Challenges in Implementation and How to Overcome Them

While essential, validation and verification have a few issues for you to overcome. First, you might have to schedule a block of time. Either or both may have set periods of time before giving you the results.

Also, for each, you may have to use extra resources—material and labor—to produce the results. Don't forget about documenting the stages as you progress.

You must also take specialization into account. Some industries need a skill level to validate and verify results.

Finally, stay current on changing processes. New techniques and new software affect how the process works. You might have to make adjustments over time.

Key Types of Process Validation Methods

Let's look at four primary methods.

Design Validation

Ensuring the process design meets predetermined specifications. For instance, in the software industry, this makes sure that software requirements accurately translate into a functional design.

Installation Qualification (IQ)

Equipment and utilities might work properly, but not if technicians install them incorrectly. In the semiconductor industry, IQ ensures that you have the correct cleanroom equipment installed and calibrated according to specifications.

Operational Qualification (OQ)

Confirming that equipment and utilities function as intended under specified conditions. In the food and beverage industry, OQ ensures that processing equipment like pasteurizers operate within specified parameters.

Performance Qualification (PQ)

Here, we want to demonstrate that the entire process consistently produces a product meeting predetermined specifications. Returning to the pharmaceutical industry, PQ sees that the entire drug manufacturing process consistently produces the desired product. This means having the same potency, purity, and stability every time.

Stages of Process Validation

Let's shift to the three stages.

Process Design

This initial stage of development details process procedures and specifications. Here, you use foresight for obstacles, offer solutions, and choose the right path down which to venture.

In the biotechnology industry, for instance, this stage involves defining fermentation parameters, purification steps, and fill-finish procedures.

Process Development

In this stage, you conduct initial process runs to gather data and note and make refinements. Of course, you want efficiency and a good return on investments for materials and labor.

In the food industry, this might involve testing different recipe formulations and processing conditions to optimize product quality.

Process Validation

Finally, you execute a formal validation protocol to demonstrate process consistency. Quality checks, taste tests, chemical analyses, test subjects, etc.

In the medical device manufacturing industry, this stage involves conducting multiple production runs under controlled conditions to demonstrate consistent product performance.

Of course, you'll need proper documentation for each phase of the above three steps. You'll want a history for future projects and products.

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The Role of a CMMS in Process Validation and Verification

Where does CMMS software play a role in all these processes? It can support the validation and verification efforts by tracking asset maintenance, calibration, and performance data.

For instance, tracking equipment readings means you have better oversight of consistent machine operations. As an example, you don't want extreme temperature fluctuations on a particular machine that might damage the product and produce a safety hazard.

A CMMS acts as a central database for maintenance history, documenting completed jobs for regulatory compliance.

With preventive maintenance (PM) cycles and schedules created, technicians stay efficient. They identify problems before they turn into serious matters.

Just as you want accuracy and consistency in your processes, a CMMS has both. Accurate inventory quantities and standardized lists and work orders.

It will generate key performance indicator reports to show you variations and where to improve maintenance operations.

Strengthening Your QMS with Process Validation and Verification

Companies need process validation and verification for various operations. Product development, maintenance operations, labor efficiency, and effectiveness.

Take time to study each. Adapt the stages for implementing them to your company's needs and goals.

You want a better product. You want a reduction in costs and safety risks. You want improvements to overall operations.

Don't discount the benefits of a CMMS. A quality system offers easy navigation and an array of features to help maintenance, purchasing, and reports. For a superior and versatile system, call 800-922-4336. Ask for a free demonstration of the powerful and easy-to-use system from Mapcon Technologies.