Validation and verification of software in critical safety systems is an essential process to ensure that products comply with regulatory requirements and provide reliable and safe results. These critical systems may include applications used in drug research and development, manufacturing, quality control, supply chain tracking, clinical data management, and pharmacovigilance, among others.

Software validation involves confirming that the software meets previously established specifications and requirements. On the other hand, verification focuses on demonstrating that the software has been developed in accordance with specific standards and regulations. Because the pharmaceutical sector and medical devices are critical safety systems, it is crucial that the software is validated and verified to ensure that its use does not jeopardize patient health.

Some key aspects to consider in the validation and verification process in the pharmaceutical and medical device industry are:

  1. PLANNING: Define a validation and verification plan that includes objectives, scope, necessary resources, and a schedule. Identify applicable regulatory requirements, such as guidelines from the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.
  2. REQUIREMENTS: Document system requirements, including functional and non-functional requirements. These requirements should be clear, measurable, and traceable.
  3. DESIGN and DEVELOPMENT: Ensure adherence to robust software development practices and comply with recognized quality standards and norms.
  4. TESTING: Conduct comprehensive testing to ensure proper software operation. This may include integration testing, system testing, regression testing, and performance testing. Additionally, perform specific validation tests to ensure that the software meets established requirements.
  5. DOCUMENTATION: Generate detailed documentation of the entire validation and verification process, including test results, identified issues, and corrective actions taken. This documentation is crucial for demonstrating regulatory compliance.
  6. CHANGE MANAGEMENT: Implement a robust process for managing software changes and ensuring that changes are adequately evaluated and validated before implementation.
  7. MAINTENANCE: Establish procedures for ongoing software maintenance, including version management, updates, security patches, and issue management.


It is important to note that specific requirements may vary depending on jurisdiction and applicable standards.

At SQS, we offer independent verification and validation services that allow our clients to incorporate software quality activities throughout their development processes. Furthermore, the experience gathered at SQS over the years in standards and norms such as Celenec, IEEE, ISO, FDA & EMA enables us to tackle a project from scratch.

For more information, contact us at .