QMS Software Validation: Ensuring Compliance with FDA, ISO and Industry Standards

June 5, 2025

QMS software validation is a critical requirement for ensuring your quality management system (QMS) operates in compliance with FDA, ISO and other regulatory standards. Ensuring that your QMS software functions reliably and compliantly is mandated by many governing bodies. Whether you're manufacturing pharmaceuticals, designing medical device components or processing supplements, the software that underpins your quality processes must be validated to perform as intended.

Taking on QMS software validation may sound overwhelming, but many modern QMS providers, like QT9, offer solutions that reduce the burden of QMS software validation. QMS software validation provides documented evidence that your digital quality system supports compliance, mitigates risk and upholds product integrity.

This article explores what validated QMS software is, why it matters, key regulations that require QMS validation and the processes undertaken to achieve it. It also highlights best practices and the benefits of using pre-validated QMS solutions to streamline compliance efforts.

What is QMS software validation and why it matters?

QMS software validation refers to quality management system software that has undergone a documented validation process to ensure it consistently performs as intended and in compliance with regulatory standards. The level of validation necessary is based on the software’s impact on product quality and safety in alignment with industry guidance, such as GAMP 5 (Good Automated Manufacturing Practice) for pharmaceutical and biotech engineering.

Why is it important to have validated QMS software?

Validated QMS software is especially important in highly regulated industries, such as pharmaceuticals, medical devices and life sciences. Regulatory governance in these industries requires that any software used in operations have documentation that proves the software works as intended in compliance with regulatory standards.

For industries where QMS software validation is a regulatory requirement, noncompliance can have dire consequences, including civil and legal penalties, fines, product recalls, and damage to reputation and market share.

Key regulations that require QMS software validation

Regulations that require QMS validation include:*

FDA 21 CFR Part 11

This U.S. statute covers Food and Drug Administration (FDA) requirements for electronic records, signatures and computer systems. It specifies that systems must be validated to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records.

FDA 21 CFR Part 820

Also known as the Quality System Regulation (QSR), 21 CFR 820 requires medical device manufacturers to validate computer or automated data processing systems when used as part of production or as the quality system for its intended use. Any changes to software must be re-validated before implementation and documented proof of validation be made available.

ISO 13485:2016

This is the current international standard defining quality management systems for the medical device industry. It requires QMS software be validated before use and after any changes are made to the software. Validation activities must be equivalent to the risk associated with the use of the software.

EU GMP

This section of European Union pharmaceutical quality standards requires manufacturers to validate software systems throughout their lifecycle to ensure systems perform as intended. Software validation must align with quality management, including ensuring appropriate risk assessments, data integrity, evidence of testing methods and documentation.

EU MDR

This EU medical device regulation requires QMS software be validated to ensure the software performs as intended and meets regulatory requirements supporting quality and risk management.

*Note that this is a cursory overview of QMS software validation requirements. Consult the appropriate governing body for more detailed information about software validation requirements.

What is computer system validation (CSV) and how is it related to QMS software?

Computer System Validation (CSV) is the documented process of verifying that a software system performs reliably, securely and in compliance with its intended use. It ensures electronic systems in regulated industries support product quality, data integrity and regulatory compliance.

QMS software validation is a specialized application of CSV focused specifically on digital quality systems. It applies CSV principles to document that QMS software meets regulatory expectations such as those in FDA 21 CFR Part 11, ISO 13485 and GAMP 5.

What is the process to validate QMS software?

Again, QMS software validation steps will vary depending on the industry or regulation, however, the typical software validation process involves the following key steps:

1. Create User Requirements Specifications (URS)

User Requirements Specifications define what the end user needs the software system to do. It sets the benchmark for QMS validation by specifying the intended use, required functions, performance criteria and regulatory expectations the software must meet.

2. Determine Functional Requirements Specifications (FRS)

Functional Requirements Specifications define how the validated QMS software will fulfill the user requirements detailed in the URS. It translates business needs into specific, testable system behaviors and functions.

3. Risk Assessment

The risk assessment step of software validation seeks to identify, assess and control potential risks associated with using the software in a regulated environment. It determines how the software could impact product quality and safety, evaluates risks and offers controls to address potential risks.

4. Installation Qualification (IQ)

Installation Qualification ensures that the software and its supporting infrastructure (e.g., hardware, operating system, database) are installed correctly and securely.

Key IQ Activities:

• Verify that the correct software version is installed
• Confirm all dependencies (e.g., web servers, databases) are present
• Check user accounts, permissions, and security settings
• Document system configuration (e.g., server specs, network settings)
• Archive vendor installation guides and certificates (if applicable)

IQ Deliverables:

• IQ Test Plan
• IQ Test Scripts and Evidence
• IQ Summary Report

5. Operational Qualification (OQ)

This step verifies that the software functions according to its Functional Requirements Specification (FRS) under controlled conditions.

Key OQ Activities:

• Execute test scripts based on system functions (e.g., user login, data entry, report generation)
• Validate role-based access controls and security features
• Test error handling, warnings, and system alerts
• Validate audit trails and electronic signatures (if applicable)

OQ Deliverables:

• OQ Test Plan
• Executed OQ Test Scripts
• OQ Summary Report

6. Performance Qualification (PQ)

Performance Qualification ensures the software performs consistently and reliably under real-world conditions, using actual users, data and processes.

Key PQ Activities for QMS validation:

• Test the system in the production or simulated production environment
• Use real workflows and typical user actions (e.g., closing a CAPA, approving a training record)
• Confirm end-to-end scenarios align with the URS
• Evaluate system performance, stability, and user acceptance

PQ Deliverables for QMS validation:

• PQ Test Plan
• User Acceptance Test (UAT) scripts
• PQ Summary Report or UAT Report

7. Validation Report

The validation report summarizes the results of the software validation process. No critical issues can remain open for the system to be considered validated. Once the validation report is complete, a validation certificate is issued. The certificate provides verification that the system passed all validation tests and meets its intended use.

Top best practices for QMS software validation in regulated industries

Validating QMS software is not just a one-time activity, it’s a continual process that ensures your system consistently meets regulatory requirements and supports product quality and safety. By following structured best practices, especially those aligned with commonly accepted standards, organizations can maintain confidence in their digital quality systems and better ensure regulatory compliance.

Below are key practices to build strong, defensible QMS software validation reports.

• Use a risk-based approach.
• Maintain comprehensive documentation, especially URS, IQ, OQ, PQ validation reports.
• Use a controlled change management process to document and assess changes to the software, configuration or environment.
• Perform impact and risk assessments for each change to determine if revalidation is necessary.
• Ensure traceability for changes and link them back to relevant validation documentation.
• Conduct periodic reviews and revalidation as needed.
• Ensure audit trails that document system security and data integrity.

What is pre-validated QMS software?

Arguably, the premier QMS software validation practice is to opt for pre-validated QMS software. A pre-validated, or fully validated, QMS software solution means the vendor has already undertaken the validation process. In other words, the vendor has rigorously tested and documented that its software performs as intended and meets regulatory requirements and standards. QT9 QMS software is a fully validated system.

Benefits of using fully validated QMS software

Fully validated QMS software can save companies countless hours and thousands of dollars. Advantages of using a pre-validated QMS include:

• Eliminating the need to spend resources on validation testing and documentation
• Reducing the risk of non-compliance with validation regulations
• Improving audit readiness through simplified, accessible validation documentation
• Simplified QMS software integration and implementation

QT9 QMS comes fully validated

If you’ve avoided investing in Quality Management System (QMS) software because of the software validation process, we’re here to tell you to look again. Fully validated QMS solutions, like QT9 QMS, remove the validation burden and ensure that your QMS software functions reliably and compliantly.

QT9 QMS is a fully validated QMS system and offers free continuous validation, which means validation, even for software updates, is free. Other QMS software providers offer validation packages, where pre-validation is available at an additional cost. Still others provide templates, consulting services or other ways that simplify and speed the validation process.

In addition to being GAMP 5 validated, QT9 QMS maintains compliance with several regulatory requirements, such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR parts 11, 210, 211, 212 and 820, EU Annex 11, and AS9100.

Learn more about QT9’s fully validated QMS software and how it supports regulatory compliance. Request a demo of QT9’s pre-validated QMS software here.

QMS software validation conclusion

QMS software validation is crucial to ensuring that regulated businesses can operate with confidence, meet industry-specific compliance requirements and avoid the risks associated with software failure or noncompliance. By following a structured, risk-based validation process and adhering to relevant regulatory standards, organizations can safeguard product quality, maintain data integrity and be fully prepared for inspections and audits.

For companies looking to simplify and accelerate compliance, pre-validated QMS solutions offer a practical and cost-effective alternative. With built-in validation support, platforms like QT9 QMS reduce the burden on internal teams, improve audit readiness and ensure that your quality system remains robust, secure and compliant from day one.