Verification and Validation (V&V) 

Within regulated industries like pharmaceuticals, medicine, biotechnology, QMS is dependent on two major processes, verification and validation. These two processes make up the primary building blocks of a QMS framework and help ensure that products are built correctly and for their intended use. If an organization misunderstands or misuses the terms, then there will possibly be failed audits, product recalls, noncompliance with regulations, and loss of revenue for the organization. 

The difference between verification and validation becomes increasingly important during ISO certification audits, regulatory audits, and quality compliance reviews. Failing to understand verification and validation could lead to gaps in quality control resulting in unsafe products and a negative impact on the credibility of the organization. 

Understanding Verification in QMS 

Verification can be defined in terms of QMS as the act or process of verifying that products, services or systems meet defined requirements /design specifications. According to ISO 9000, verification is viewed as “confirmation through the provision of objective evidence that specified requirements have been fulfilled”. The act of verifying answers the question “are we building the product right?” 

Verification activities are conducted to determine if deliverables satisfy criteria and specifications which were established for the project during the design phase. Verification activities usually are performed during the development or design phase of a project and usually include document review, inspection, and testing against predetermined benchmarks.  

Verification of design will ensure that the design outputs are conforming to the design inputs, which is critical for medical devices under ISO 13485 as they are subject to stringent regulations governing how the design is generated. Process verification will provide evidence that in-process verification activities such as equipment calibration and environmental monitoring are meeting pre-determined conditions. Software verification is to confirm the operation of code based on various programmatic or technical specifications. 

Standard verification methodologies in the context of medical devices include performing inspections of the product to verify visual or dimensional quality of parts, accomplishing walk-through inspections with peer review on relevant documentation or designs, doing successful functional tests to evaluate product performance with the requirements, and carrying out simulation activities utilizing models to check product performance without using physical prototypes. 

In a regulated environment, verification is a mandatory component of the design control process outlined in ISO 13485 and 21 CFR 820. Organizations are required to prepare comprehensive verification protocols, maintain relevant records, and ensure activities align with the organization's broader quality management system policies to avoid the potential for major nonconformities during audit activities. 

Validation is the process of providing evidence that products or services meet the customer's requirements and intended uses under real world conditions. According to ISO 9000, “Validation is confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.” Verification asks, “Are we building it right?” Validation provides an answer to the question, “Are we building the right product?”