• Computer Software Assurance CSA

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 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.

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 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…
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