Equipment Validation – EV

Documented impact assessments (Utility Validation) should be performed on all utility systems including water, steam, air, process gases, heating, ventilation, and air conditioning (HVAC) and others.

Retrospective Validation is the validation of a system already in use, based upon accumulated data. A Retrospective Validation is typically carried out when there is a new requirement for a system to be compliant or a gap in GxP compliance has been identified.

Process validation is the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process can consistently deliver a product.

Life Sciences industry regulations require validation and change control for Analytical Test Methods used for analysis of product and product components.  Test methods must be well defined, well characterized for precision and accuracy and validated, including formal design review to authenticate methods suitable for intended use.

Continuous Process Verification is another possible approach to Process Validation. Manufacturing process performance is continuously monitored and evaluated.

Computer System Validation is the process used to test, validate, and formally document that a regulated computer-based system does precisely what it is designed to do — consistently and accurately — and in a way that is secure, reliable, and traceable.

A new method of computer system validation (CSV) recommended by the U.S. Food and Drug Administration (FDA) to validate software used in regulated production. CSA focuses on risk-based analysis to reduce documentation burden and improve the adoption of technology that enhances product quality and production methods.

Commissioning and qualification (C&Q or sometimes CQV) are two distinct steps of validation, usually in the installation or maintenance of machinery or startup of facilities. While different, they’re often executed together in sequence and referred to as a unit.

Commissioning: A well-planned, documented approach to the start-up and turnover of facilities, systems, and equipment to the end user.

Qualification: The documented verification that all aspects of a facility, utility, or equipment that can affect product quality adhere to approved specifications.

Life Sciences industry regulations require all critical systems and equipment used in the cold chain logistics (packaging, storage, and distribution) be validated and maintained in a validated state throughout the product’s life cycle.

Cleaning Validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive or detergent ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.

Life Science industry regulations require laboratory analytical instruments to be validated and maintained in a validated state throughout the instrument’s life cycle. Analytical Instrument Validation requirements may include instrumentation, computer system validation, test method and perspectives, with supporting documentation required from both system owner testing and vendor performed tests.