Software validation, according to the U.S. Food and Drug Administration (FDA), is the process of verifying that software functions in a manner that complies with its intended use and that it meets specified requirements.

In the context of medical devices and pharmaceutical products, software validation is a critical step in ensuring patient safety and product quality. The FDA requires that software used in medical devices be validated to ensure that it performs its intended functions and that it meets certain regulatory requirements.

Software validation involves a series of activities, including testing, documentation, and verification, that are designed to ensure that the software is reliable, accurate, and consistent with its intended use. The process may include testing the software under different conditions and scenarios, verifying that the software meets specified performance criteria, and documenting the results of testing and verification.

An Electronic Quality Management System (eQMS) must be validated to ensure that it is designed, developed, and deployed following regulatory requirements and industry standards. eQMS validation is a process of demonstrating that the eQMS software is reliable, accurate, and consistent with its intended use and that it meets regulatory requirements and industry standards.

Here are some reasons why eQMS must be validated:

• Regulatory Compliance: Validation of eQMS is required by regulatory bodies such as the FDA, EMA, and other regulatory agencies to ensure that the eQMS system meets the requirements of current Good Manufacturing Practices (cGMP) and other regulatory standards.
• Quality Assurance: Validation of eQMS ensures that the system meets the intended purpose and user requirements. It ensures that the eQMS software is performing as expected and that it can be relied upon to accurately manage quality processes.
•  Risk Management: Validation of eQMS identifies and mitigates risks that may arise from the use of the eQMS system, including data integrity, security, and system functionality.
•  Continual Improvement: Validation of eQMS ensures that the system is continually reviewed, updated, and improved to meet changing regulatory requirements and business needs.

Validating an Electronic Quality Management System (eQMS) involves several components, including validating the EQMS platform and configuration. Here’s an overview of what these components entail:

1. Platform Validation: This involves validating the eQMS platform to ensure that it meets regulatory requirements and industry standards. The platform includes the hardware, operating system, database management system, and middleware used to support the eQMS software. Platform validation involves testing the performance and functionality of the platform and verifying that it is secure, reliable, and scalable.
2. Configuration Validation: This involves validating the eQMS software configuration to ensure that it meets user requirements and is aligned with regulatory requirements and industry standards. Configuration validation involves testing the system to ensure that it performs its intended functions, that it is properly configured and customized, and that it meets user requirements.
3. Data Validation: This involves ensuring the accuracy, completeness, and consistency of data entered into the eQMS system. Data validation includes verifying that the eQMS system can process data without errors and that it maintains data integrity.
4. User Acceptance Testing (UAT): This involves testing the eQMS system with end-users to ensure that it meets their needs and expectations. UAT involves identifying and resolving any usability issues, ensuring that the eQMS system is user-friendly and that it meets user needs.
5. Documentation: eQMS validation involves maintaining detailed documentation of the validation process, including documentation of the testing procedures, test results, and any corrective actions taken.

In summary, validating an eQMS involves several components, including platform validation, configuration validation, data validation, user acceptance testing, and documentation. By validating each of these components, you can ensure that the EQMS system meets regulatory requirements, industry standards, and user needs.

As an entity deploying eQMS and to ensure your validation is lightweight yet effective, you would want to rely as much as you can on your eQMS provider in doing most of the validation components mentioned above. Many organizations assume that they can delay thinking about how to make validation lightweight until after they have an eQMS in place, but that is a common mistake because validation on your side can only be lightweight if you wisely select the right eQMS provider and the right platform.

Top things to consider in selecting a QMS provider for effective lightweight validation on your side:

1. Validated Platform: The platform vendor has already performed a significant portion of the validation activities. This means that the vendor’s platform has been thoroughly tested and verified to meet regulatory requirements, reducing the amount of validation effort required by the organization. Make sure the eQMS provider distributes a validation documentation package for every platform update, and make sure the cost of the package does not break the bank.
2. Regulatory compliance: Validated platform vendors have already demonstrated that their platform meets regulatory requirements (e.g., 21 CFR part 11). This means that organizations can be confident that the software system will meet regulatory requirements, reducing the risk of compliance issues.
3. Platform Ownership: The platform is owned by your eQMS Provider, if the vendor is using a 3rd party “not-validated” platform, the validation that your vendor is doing on top will be shaky, especially with the number of updates that get pushed by the 3rd party platform provider.
4. Cloud-based: If the eQMS platform is deployed on-premise, that makes the validation effort on your side huge. You will need to qualify servers and the underlying operating system installation, run and document Installation Qualification (IQ), and consider what needs to be done with every update. By choosing a cloud-based deployment model that is fully managed by the vendor you transfer the responsibility of all of these activities to the vendor.
5. Configurability: This means you can configure eQMS modules (CAPA, Complaints, etc.) and tailor them according to your organization’s needs. Going the configuration route means you have to validate what you have configured. Several vendors offer out-of-the-box validated modules. You have to be very careful with this model. It looks very attractive as it makes the validation on your side easier, but the reality is that your team will be dragged to doing tasks that are more expensive and time-consuming than the validation itself. Like adjusting your internal process to work according to carved-in-stone modules to finally find out that the out-of-the-box modules do not work for your needs. Configurability is Key, and only very few vendors offer the right level of configurability in their platforms. A lack of configurability makes validation easier on your side but that creates a bigger problem for you.
6. Validation as Service: In the previous point, I explained the importance of configurability, which means you have to validate what you configure. If you do not have the resources or the bandwidth to do this validation, you would want to ensure that your vendors offer a service to validate your configuration.
7. Validation Tool: If you plan to validate your configuration on your own, it is important to ensure your eQMS Vendor provides a Validation Tool that is fully integrated into the same system to help your team do the validation activities digitally and simply. The validation tool itself should be validated by the vendor as well.
8. Validation Automation: Few vendors offer automation tools to automate the test protocol (e.g., Process Qualification (PQ)), with this level of automation instead of executing the test manually based on documented steps, a script will run to execute the test for you. If you plan to do the initial configuration validation and/or future maintenance on your own, then you have to consider what is best for your team based on the differences table below.

If you have a small non-technical validation team, then going the automation route could be overwhelming.

 

9. Platform Updates: You will need to assess the platform update model the EQMS provider is offering. If your configuration cannot survive a platform update, then validation will be extremely hard for your team.

 

10. Configuration Management: You will need to assess the configuration management approach your vendor is offering. For your validation to be lightweight and effective, you should be offered at least three isolated environments, and you should be able to clone your configuration from one environment to the other without having to do a fully documented repeat.

·        Dev: to implement your configuration.

·        Val: to validate your configuration.

·        Prod: for end users’ use.

Now that you have carefully selected the right eQMS Provider for lightweight validation, you would want to make sure that they do the validation effectively by either auditing them or by doing thorough reviews of their validation packages. The goal is to make the validation not only lightweight but also effective on your side, and that can only be achieved if the vendor you selected is performing validation thoroughly for all the validation elements you transferred to them.

The next step is to focus the efforts of your validation team on the validation reviews (of what the vendor validates), as well as validating configured modules using the tools offered by your vendor to digitalize the validation process.

One approach to validating the eQMS module configuration is to use a risk-based approach. This involves identifying and evaluating potential risks associated with the system’s configuration and prioritizing them based on their level of impact and likelihood. By focusing on the most critical risks first, your organization can ensure that the eQMS module configuration is robust and effective, minimizing the potential for errors and reducing the likelihood of adverse events. The risk-based approach to eQMS module configuration validation also helps your organization to allocate its resources more efficiently. Overall, by adopting a risk-based approach to eQMS module configuration validation, your organization can improve the quality and effectiveness of the eQMS, reducing the potential for errors, and increasing your ability to achieve your quality and compliance objectives.

eQMS Software validation is a critical process and deserves proper attention as well as making some gutsy decisions to select tools that allow the validation team to perform their tasks using modern tools and systems by vendors that have addressed and overcame validation challenges and considered how complicated and involved this process can become.

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