• Method Validation – MV

Method Validation – MV

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.

Other Glossary Terms

  • 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…
  • 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…
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