Software validation explained simply

Software validation is essentially important for two reasons:

Patient safety

It ensures that the software is suitable for its intended use and functions reliably and error-free. This prevents mistakes and quality issues, ensuring maximum patient safety.

Regulations

It ensures that legal and regulatory requirements in sensitive industries are met – for example, FDA 21 CFR Part 11.

Computer system validation looks at all aspects of a computer system. In addition to the software, this includes hardware, networks, and interfaces. This ensures that all components involved function reliably.

Software validation, on the other hand, focuses exclusively on the software application itself. It verifies whether the application meets the defined requirements and is suitable for its purpose. In other words, software validation is one element of computer system validation.

Is software validation mandatory?

Yes. Companies operating in regulated industries are required to validate their software. This applies in particular to the pharmaceutical and medical technology sectors, which are bound by regulations such as FDA 21 CFR Part 11, ISO 9001, and ISO 13485.

1. Requirements analysis: In the requirements analysis, both functional and non-functional requirements are defined and documented.
2. Selection of the software to be validated: In the second step, the company determines which solutions are subject to validation.
3. Risk assessment: Next, the risks in the context of software validation are identified and assessed, with the aim of detecting and eliminating potential sources of error.
4. Test planning and execution: As part of test planning, test cases are created that cover all previously defined requirements. Tests are then executed in different environments, such as integration and system tests.
5. Documentation: To comply with traceability requirements, all tests are documented and results are reviewed. It is assessed whether the software meets the requirements and whether errors have been corrected.
6. Approval and release: As part of the approval and release process, a comprehensive validation report is created. This report certifies that the software complies with all defined standards.

A proven and widely recognized approach to software validation is the V-model, which follows a well-established validation plan.

ISO 13485 plays a key role in software validation in the medical technology sector. It defines the requirements for a quality management system for the development and use of medical devices and regulates the validation of the software applied. An ERP system for the medical device industry must reliably support these requirements. The main aspects are:

• Software must be validated before being introduced in the medical technology field.
• Software validation must ensure patient safety and confirm compliance with defined requirements.
• Software validation must be comprehensively documented.
• Risk management must be an integral part of software validation.
• Software must be validated throughout its entire lifecycle.

Software validation plays a crucial role in the pharmaceutical industry because it safeguards patient safety. It ensures that product development, manufacturing, storage, and quality control are carried out correctly and in compliance with standards. In addition, software validation is essential for meeting the strict legal and regulatory requirements that apply to pharmaceutical companies.

Software is initially validatedat the time of implementation. If significant changes are made later, revalidation is required. This is especially common with validated software in the public cloud. To reliably ensure the required level of safety, regular reviews of the software validation must also be performed.

Software validation is carried out through the collaboration of all stakeholders within a company. Which departments are involved depends on the industry, company size, and regulatory requirements. Typically, however, people from quality management, IT, and compliance departments, as well as the specialist departments that will use the software, are part of the implementation project.

Business Central’s industry-specific ERP is specifically designed for the needs of the process industry and seamlessly integrated into Microsoft ERP Business Central. This specialized solution was developed in strict accordance with GAMP5, tailored to the requirements of regulated environments. It fully meets the key aspects of GMP requirements and provides all prerequisites for software validation – even in the public cloud. Implementation is carried out in line with regulatory requirements, securely and efficiently, combined with expert guidance from NABs experienced consultants.

Software verification checks whether the software has been developed and implemented according to the defined specifications. The focus is on ensuring that the required designs and specifications have been executed correctly and appropriately. Unit tests and integration tests are typically used for this purpose.

Software validation, on the other hand, ensures that the solution is suitable for its intended purpose. The focus here is on functionality, which is assessed using user tests or simulations.

When software is developed with consistent documentation, it is referred to as standard software. This serves two purposes: it enables quality assurance throughout the development process and reduces implementation effort when introducing software in regulated industries (especially pharmaceuticals and medtech).

Each software release must be fully traceable and documented. In addition, the software developer is required to define internal standards and implement them in line with established quality management requirements.

A release cycle typically includes the following steps:

1. Release planning: Defining the functions of a software release based on customer requirements, market analysis, and internal priorities.
2. Functional specification: Describing software functions from a user perspective. Serves as the basis for testing and validation of customer requirements.
3. Technical specifications: Translating functional requirements into technical details such as architecture, interfaces, data models, and workflows.
4. Development: Implementing the functions in source code by the development team, following the defined standards.
5. Code review: Reviewing the source code by additional team members to ensure code quality, compliance with standards, and to prevent errors.
6. Functional testing: Comparing implemented functions with the functional specification to confirm correct functionality, using manual or automated tests.
7. Release build: Compiling the software into a deliverable version, including installation packages, release notes, and documentation.
8. Release approval: Formal approval of the release for delivery by authorized parties. Includes review of test results and, if necessary, risk assessment.
9. Bug tracking and correction: Identifying, documenting, and fixing errors from testing or post-release. Corrections are incorporated into future releases or hotfixes.

Software validation in practice – a foundation for compliant operations

If release cycles are developed according to a documented, traceable scheme, the result can be considered a pre-validated system. This makes it easier for customers to implement the software, as the standard functions have already been tested in advance. Typically, these standard functions only need to be tested within the specific process context – significantly reducing the implementation effort, particularly in validated environments.