Validation

Validation and verification are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 17025. The words "verification" and "validation" are mostly preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party such as SmartCal Validation & Calibration.

Validation is intended to ensure a product, service, or system meets the operational needs of the end-user or the stakeholder. In other words, it is a process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended or purposed requirements. This often involves the interference of the end-user to determine the acceptance for purpose or application.

Verification involves regularly repeating tests devised specifically to ensure that the product, service, or system continues to meet the initial design requirements, specifications, and regulations as time progresses. It is a process that is used to evaluate whether a product, service, or system complies with regulations, specifications, or imposed conditions.

Validation is the process of providing documented evidence that equipment, systems and processes are installed, operate and perform as specified according to global standards. The process of providing the necessary documented evidence is most commonly accomplished through the development of two different but complimentary groups of documents. The specification documents and the validation protocols.

Specification documents define how the equipment or system should be installed and operated, and how the equipment or system should perform during regular use in its normal operating environment.

Installation Qualification, Operational Qualification and Performance Qualification protocols in turn, provide a series of tests and results that support the conclusion that the equipment or systems completely meets the requirements defined in the Design, Functional and User Requirement Specification.

SmartCal Validation & Calibration Laboratory provides high-quality validation services to the pharmaceutical, biotechnology and medical device industries.