QMS Software Validation - Checking Boxes

QMS Software Validation: Everything You Need to Know

by | Jan 12, 2024 | QMS

QMS software validation is the process of ensuring that a Quality Management System (QMS) software application is fit for its intended purpose.

Quality system software validation is a requirement when the software is used to manage regulated processes in Life Science industries, which include pharmaceutical, biotechnology, and medical devices, among others.

This article will discuss the definition of QMS software validation, when and why electronic QMS (eQMS) validation is important, relevant requirements, validation methods, benefits, and the role of fully validated eQMS software in helping ensure quality and compliance.

Companies have been increasingly adopting eQMS (Electronic Quality Management System) solutions to streamline their quality processes and improve their compliance efforts.

SimplerQMS provides fully validated QMS software designed specifically for Life Science companies. Book a demo and talk to our quality experts to get a deeper understanding of our eQMS solution.

We will discuss the following topics in more detail:

What Is QMS Software Validation?

QMS (Quality Management System) software validation is the process of systematically verifying and documenting that QMS software meets predefined requirements, operates effectively, and complies with regulatory standards. QMS software validation falls under the broader category of Computer Systems Validation (CSV), which ensures the integrity and compliance of computerized systems.

QMS software validation involves creating and executing protocols, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

SimplerQMS provides a fully validated eQMS according to ISPE GAMP 5 and performs continuous revalidation. This means that our customers do not need to validate computer software themselves and can be confident that their eQMS is compliant and ready to use right away.

Why QMS Software Validation Is Important?

QMS software validation is important to demonstrate that the eQMS software performance is accurate and consistent. This ensures the integrity and quality of documentation and processes managed within the system.

Companies using software for managing QMS must comply with applicable FDA and ISO requirements concerning system validation.

When Electronic QMS Validation Is Necessary?

QMS software validation is necessary when it is required as per applicable regulatory requirements, specifically when computer software is used to control the quality management system.

QMS software must be validated before use and revalidated as necessary to follow any changes, according to ISO 13485:2016 Section 4.1.6 and FDA 21 CFR 820.70. Both requirements mandate these validation activities and their results to be documented.

Which Requirements Specify eQMS Validation?

QMS software validation is a requirement in several regulations, standards, and guidelines in the Life Science industry.

Below are some requirements that require eQMS validation.


This section will discuss some requirements that specify QMS software validation in the Life Science industry. However, this is not an exhaustive list. Please always refer to the official requirements applicable to your company.

FDA 21 CFR Part 11

The Food and Drug Administration (FDA) regulation 21 CFR Part 11 sets forth the criteria for electronic records, signatures, and computer systems to be trustworthy and reliable.

Regarding QMS software validation, section 21 CFR 11.10(a) specifies that systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

To learn more about this and other requirements in 21 CFR Part 11, read our dedicated article.

EU GMP Annex 11

The EU GMP Annex 11 provides the Good Manufacturing Practices (GMP) on the use of computerized systems in the Life Sciences industries in the European Union.

Section 4 provides general principles for validating computerized systems used in manufacturing pharmaceutical products. This section specifies the requirements for validation documentation, test methods, system inventory, and more.

Check out our article on Annex 11 for a deeper explanation of what this guideline entails.             

ISO 13485:2016

The international standard ISO 13485:2016 specifies the requirements for a quality management system for medical device companies.

It is established in Section 4.1.6 that the application of computer software used in the quality management system must be validated before use and after changes. The validation activities need to be equivalent to the risk associated with the use of the software.

If you are interested in knowing more about what an ISO 13458:2016 compliant QMS encompasses, read our article.

FDA 21 CFR Part 820

The FDA 21 CFR Part 820, also known as quality system regulation, sets forth the cGMP requirements for medical devices. These requirements are intended to ensure that the devices are safe and effective.

Section 21 CFR 820.70(i) states that manufacturers must validate computer or automated data processing systems when used as part of production or the quality system for its intended use.

All software changes must be validated before approval and implementation, and these validation activities and results need to be documented.

Read our article to learn more about 21 CFR Part 820 purpose and requirements.

GMP Guide Part II APIs

The GMP Guide Part II APIs is a set of international guidelines that provide guidance on GMP for the manufacturing of active pharmaceutical ingredients (APIs) in a way that meets the required quality and purity requirements.

In Section 12, it is defined that the company’s approach to validation, including the validation of computerized systems, should be documented. Systems should be periodically evaluated to verify that they are still operating in a valid manner.

How Is the QMS Software Validated?

QMS software validation is conducted through a structured process involving specific steps.

QMS software validation steps are listed below.

  1. Risk Management
  2. Validation Planning
  3. Installation Qualification (IQ)
  4. Operational Qualification (OQ)
  5. Performance Qualification (PQ)
  6. Validation Reporting, including the Validation Certificate
QMS Software Validation Process

1. Risk Management

Risk management is the systematic process of identifying and addressing potential risks associated with software development, updates, and implementation.

Risk management actions should be performed to determine the impact of the software application on product quality and data integrity.

A comprehensive risk assessment and control process identifies and documents all potential risks, serving as input for developing a risk-based test plan and executing effective test cases.

The risks can be related to the software’s functionality, performance, security, and usability.

The ISPE GAMP5 guidance document provides a risk-based approach to compliant GxP computerized systems.

The GAMP5 aims to deliver a cost-effective framework of good practices to ensure that computerized systems are effective, high-quality, fit for intended use, and compliant with applicable requirements.

SimplerQMS is fully validated according to ISPE GAMP5 and undergoes revalidation for each new version or standard update.

2. Validation Planning

The validation plan is a document that outlines the system scope, development methodology, validation measures, and associated procedures.

The validation plan guides the process of ensuring that a software system meets its intended purpose and complies with relevant requirements. It serves as a roadmap for conducting validation activities and provides a framework for measuring the success of these efforts.

3. Installation Qualification (IQ)

Installation qualification is confirmed through documented evidence that the installation of all system components adheres to the established specifications.

The installation qualification verifies that items such as equipment, instruments, computer system components, measuring devices, and more are installed following the approved design, the manufacturer’s recommendations, and user requirements.

4. Operation Qualification (OQ)

Operational qualification ensures that the system or subsystem operates correctly and produces the expected results over all the anticipated operating ranges.

Appropriate operational qualification should demonstrate the suitability of computer hardware and software to perform assigned tasks.

In major software updates, OQ confirms the system’s readiness for stricter performance tests, ensuring its functionality before deployment.

5. Performance Qualification (PQ)

The performance qualification verifies that each component in a computer system works as intended and meets performance requirements. It ensures the system can handle its workload and deliver reliable results.

Performance qualification is typically conducted for major software version upgrades.

6. Validation Reporting, including the Validation Certificate

A validation report is a comprehensive document summarizing the results of a system’s validation process. It serves as a tangible record of the entire validation effort, documenting activities, findings, and, ultimately, the system’s suitability for its intended use.

Importantly, no critical issues can remain open for the system to be validated.

After a successful software validation, the validation certificate is issued. A validation certificate is a formal document stating a system has passed all validation tests and meets its intended use requirements.

We recommend watching the video below for a comprehensive overview of an eQMS validation process.

What Are the Benefits of QMS Software Validation?

The primary benefits of QMS software validation include confirming the proper functionality of the software as intended and adhering to regulatory requirements for compliance.

Below are other benefits of QMS software validation.

High Level of Security

QMS software validation helps to identify potential security risks associated with the software. Validation ensures that the software operates consistently within defined parameters, minimizing risks related to software failure or functional errors that could impact product quality or patient safety.

Comprehensive and Continuous Software Testing

Electronic quality system validation ensures that critical systems are thoroughly and continually tested. This is important because systems can change over time, and the testing process needs to be updated to reflect these changes.

Continuous testing helps to identify and fix any defects or errors before they cause larger issues in daily use.

Effective Risk Assessment

EQMS validation includes assessing potential risks associated with the software. The proactive approach to identifying and mitigating risks minimizes the probability of errors or failures that could impact product quality and safety.

Enhanced Reliability

A validated QMS software is generally more reliable because it has undergone rigorous testing. This ensures that all functions work as intended in different scenarios and conditions.

Data Integrity

Validation processes include steps to ensure that data is accurately recorded and maintained, thereby improving the overall integrity of the data.

The benefits of QMS software validation are numerous and far-reaching. Maintaining a validated QMS software is essential for any Life Science company wanting to achieve these benefits.

What Is the Role of Fully Validated eQMS Software?

The main role of fully validated eQMS software is to help ensure regulatory compliance and quality assurance across all organizational processes.

Validated quality management software is a centralized system streamlining quality processes and storing relevant documentation. It helps ensure that the company complies with internal and external requirements.

Companies have three options for QMS software validation, as listed below.

  • Do it themselves.
  • Outsource to a service provider.
  • Use fully validated QMS software like SimplerQMS.

The best option for each company will depend on its specific needs and requirements.

However, validating QMS software yourself can be challenging, as it involves a manual process that can be time-consuming and costly. Outsourcing to specialized service providers can also be expensive.

On the other hand, fully validated QMS software can provide everything a company needs and give the peace of mind of using a validated system that saves time, costs, and work in validation and revalidation tasks.

SimplerQMS provides a fully validated eQMS according to ISPE GAMP5. We maintain our software in a validated state by updating it whenever new versions or changes are introduced. SimplerQMS handles all validation tasks for our customers.

In addition to being ISPE GAMP5 validated, our platform supports compliance with several Life Science requirements such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 210, 211, 212, and 820, EU GMP Part I, EU GMP Annex 11, and more. SimplerQMS software helps companies achieve regulatory compliance by providing comprehensive QMS process support.

Our solution supports QMS processes, including document management, change control, employee training, deviation management, CAPA management, customer complaint management, audit management, supplier management, and more.

If you are unsure about the benefits of implementing an eQMS, we recommend using our eQMS Business Case template. This tool will help you assess the value of eQMS for your company and present your findings to management.

The template provides a structured approach to evaluating aspects such as cost savings, improved efficiency, and enhanced regulatory compliance.

Downloadable eQMS Business Case Template Banner

Final Thoughts

QMS software validation is essential to ensure that the quality management system software works as intended and to comply with regulatory requirements for companies in regulated industries.

QMS software validation can be done by the company itself or by an outsourced service provider. However, both of these options can be labor-intensive and expensive.

A better alternative is to implement already validated software, which can save you time and costs and give you peace of mind knowing that the software is fit for purpose.

SimplerQMS provides a fully validated eQMS solution according to ISPE GAMP 5.

The software is kept in a validated state continuously, and SimplerQMS handles all validation and revalidation tasks on your behalf. This means you do not have to worry about anything and can focus on using the software to improve your quality management.

You can book a free demo with one of our quality experts to learn more about how our QMS software can help you streamline quality process management in your company.

eQMS Business Case Template

Illustration of eQMS Business Case Template