Glossary Of Terms

There are many types of validation when it comes to highly regulated manufacturing, and while they share many characteristics, it’s important to also understand their differences. Each type serves its purpose and presents its own challenges, however, a comprehensive digital validation platform like Kneat Gx, is able to empower teams no matter the validation discipline they’re working on.

  • Analytical Instrument Validation – AIV

Life Science industry regulations require laboratory analytical instruments to be validated and maintained in a validated state throughout the instrument’s…
  • Cleaning Validation – CV

Cleaning Validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active,…
  • Cold Chain Validation – CCV

Life Sciences industry regulations require all critical systems and equipment used in the cold chain logistics (packaging, storage, and distribution)…
  • Commissioning and Qualification – C&Q CQV

Commissioning and qualification (C&Q or sometimes CQV) are two distinct steps of validation, usually in the installation or maintenance of…
  • Computer Software Assurance CSA

A new method of computer system validation (CSV) recommended by the U.S. Food and Drug Administration (FDA) to validate software…
  • Computer System Validation – CSV

Computer System Validation is the process used to test, validate, and formally document that a regulated computer-based system does precisely…
  • Continuous Process Verification

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

Equipment Validation is comprised of a series of qualifications — including design, installation, operational, and performance qualification. It provides high…
  • Method Validation – MV

Life Sciences industry regulations require validation and change control for Analytical Test Methods used for analysis of product and product…
  • Process Validation – PV

Process validation is the collection and evaluation of data from the process design stage through commercial production, which establishes scientific…
  • Retrospective Validation

Retrospective Validation is the validation of a system already in use, based upon accumulated data. A Retrospective Validation is typically…
  • Utility Validation – UV

Documented impact assessments (Utility Validation) should be performed on all utility systems including water, steam, air, process gases, heating, ventilation,…
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