Process validation explained simply

The goal of any process is to consistently deliver the same, predefined results. Processes must therefore be controlled in a way that ensures consistent quality. Because this is exactly what process validation guarantees, it plays a crucial role in industry. Even if the term “validation” is not always used, the procedures are very similar.

For example, demonstrating the process capability of manufacturing processes is comparable to the approach used in process validation. This can apply to planning, manufacturing, testing, or logistics processes that are part of everyday operations. Validating these processes – in other words, designing them to consistently deliver the desired quality – is the objective.

Process validation serves to confirm in advance that processes are indeed capable of doing so. The documentation of this capability is what constitutes process validation. While the requirements for process validation differ from one industry to another, they generally follow the same basic pattern.

Process validation is not only required by GxP regulations but is also widely used in self-regulated industries such as the automotive sector. In highly sensitive industries, process validation is a fundamental building block. It ensures that processes consistently deliver reproducible and reliable results.

In other words, it confirms that an end product can always be manufactured in the same way under constant conditions. On the one hand, this guarantees consistent product quality; on the other, a secure and reliable production process also reduces costs.

In the pharmaceutical environment, process validation primarily focuses on patient safety. The main goal is to achieve strong process stability and quality – and to confirm and document this throughout the validation. Beyond that, process validation serves several additional purposes:

• Providing a structured methodology to implement new measures or changes in a planned and targeted way
• Establishing a documented basis across the entire lifecycle
• Confirming that process implementation works exactly as planned
• Detecting and correcting implementation errors
• Learning from mistakes and preventing issues from being discovered only during live operation
• Reducing costs through process stability (achieving the required quality directly and avoiding rework)
• Ensuring patient safety in pharmaceuticals and medical technology

The greatest advantage of process validation is that it serves as a tool for process control. By preventing errors – and therefore avoiding rework – it delivers direct cost savings. Additional efforts, such as stricter quality controls, can also be reduced thanks to increased process reliability, as inspections can be omitted or their scope reduced.

Another advantage lies in the strict requirement for documentation: the current state of processes and procedures can always be traced (for example, when onboarding new employees), while changes can be more easily evaluated and documented. This leads to further benefits:

• Processes are easier to understand and more transparent
• Users develop trust in the systems they work with
• Controlled systems ensure greater information security

In principle, the procedure is based on defining the requirements (for a process, a machine or system, a computer system, etc.) in a user requirements specification (URS). In addition, a functional specification (FS) describes how these requirements will be implemented and what settings or configurations (e.g., access rights, parameterization) are necessary. Implementation is documented, and both functionality and compliance with requirements are verified through defined test plans – with all results documented.

This process is often illustrated using the V-model. In the GMP environment, GAMP (Good Automated Manufacturing Practice, currently version 5) has been established as a best practice. It is widely applied as a standardized approach to validation, including in other industries such as medical devices.

In this context, the terms refer to the digital world of computer systems. While process validation in computer systems provides documented proof that a process delivers predefined results, qualification focuses on the hardware and system environment.

Qualification serves as evidence of suitability, confirming that hardware and infrastructure function correctly. In other words, it demonstrates that the equipment is capable of performing as required.

As described, process validation essentially means confirming process capability. However, many factors influence process quality – such as process design, the machines and equipment used, operating personnel, or supporting systems like computers. In this case, we speak of validating, for example, a production process.

If a production process is supported by a computer system, the use of that system must also be validated – this is known as computer system validation (CSV). CSV therefore means validating a process with regard to the use of a computer system.

Verification refers to the use of objective means to check whether specific requirements have been successfully met. This process can, for example, apply to products or components. In other words, verification confirms whether a product fully meets the predefined specifications.

Process validation, on the other hand, ensures that a process is capable of consistently delivering predefined results.

When it comes to software solutions, the focus is on computer system validation (CSV). The foundation for this is provided by GMP guidelines, which stipulate that:

• Computer systems or software must be validated before use
• Software must be capable of delivering accurate, consistent, and reproducible results

At the FDA, computer system validation is also of great importance: software validation must confirm that software specifications have been implemented in line with user requirements and intended use – and that these requirements are consistently fulfilled. To ensure this, objective evidence must be examined and documented.

Validation is particularly relevant in the pharmaceutical and medical technology industries. The reason lies in the precision required: these are highly sensitive areas where meeting predefined criteria exactly is essential. Only in this way can products – such as medicines – be manufactured reliably, giving consumers the assurance of consistent product quality.

Process validation in pharmaceutical manufacturing

In pharmaceutical manufacturing, process validation ensures that the finished product always meets the required quality standards and delivers the same results under identical environmental conditions such as temperature. Every new product requires renewed validation, regardless of whether identical or similar equipment is used.

A specific validation plan must be developed for each process validation, aligned with regulatory requirements (including EU GMP, FDA, or PIC/S). The procedures defined in the plan must be consistent with the validation SOPs. Compliance is verified and signed off by responsible individuals such as the laboratory manager or head of quality assurance. After execution of the plan, a detailed report is prepared documenting the results and any deviations. This report resembles a comprehensive inspection report, similar to those produced for vehicle inspections. Only validated methods and processes may be used to manufacture and control medicines intended for sale.

With the increasing importance of computer-based systems in pharmaceutical manufacturing, these too must comply with regulations and undergo validation. This includes ERP systems, document management systems, manufacturing execution systems (MES), and laboratory information management systems (LIMS).

Validation of medical devices

The validation of medical devices is a crucial process to ensure the safety and effectiveness of these products. To be approved for market release, medical devices must meet a range of standards, including ISO 13485 (requirements for a quality management system) and ISO 14971 (risk management).

The validation process involves careful testing and documentation of all design, production, and usage phases. It covers not only the physical components of the product but also any associated software or computer-based systems, which must be checked for functionality, usability, and integration into existing systems.

The methodology follows a structured approach: from defining requirements, through multiple testing phases, to final evaluation. This ensures that the medical device consistently delivers the expected performance and complies with legal regulations.

The validation of ERP systems is a critical process designed to ensure that these systems meet an organization’s specific requirements and function reliably.

However, several challenges arise in this context:

• Complexity of ERP systems: ERP systems consist of numerous interconnected modules and functions. This complexity makes it difficult to conduct thorough and precise process validation, as all possible scenarios and usage contexts must be considered.
• Frequent updates and customizations: Regular changes to ERP systems present a particular challenge. Each modification carries the risk of introducing new errors, which can render previous validation efforts invalid and require additional work.
• Data integrity and interface issues: Inconsistent data or poorly integrated interfaces can significantly complicate validation. If data integrity or system interoperability is compromised, the reliability of the entire ERP system is at risk.

Overall, ERP validation requires striking a delicate balance between thorough testing and the time and financial resources involved – a continuous challenge for many companies.

Yaveon 365 stands out as an ERP system designed to meet the specific requirements of computer system validation (CSV) in regulated industries such as medical technology and pharmaceuticals.

• Comprehensive documentation for CSV: Every process is documented – a fundamental requirement for computer system validation.
• Future-proof with validation-friendly updates: Thanks to regular, validation-friendly updates and an intelligent interface architecture, companies can be confident that Yaveon ProBatch not only meets current but also future regulatory requirements.
• Proven quality and reliability: Years of expertise and regular customer audits confirm the quality and reliability of the software.
• Seamless integration and adaptability: With specialized functionality and a highly modular design, Yaveon ProBatch integrates seamlessly into individual business processes – without compromising validation.
• Highest standards for data integrity and compliance: The software is built to meet the highest standards of data integrity and compliance, reducing validation effort and minimizing the risk of errors.