- November 28, 2024Documented impact assessments (Utility Validation) should be performed on all utility systems including water, steam, air, process gases, heating, ventilation,…
- November 28, 2024Retrospective Validation is the validation of a system already in use, based upon accumulated data. A Retrospective Validation is typically…
- November 28, 2024Process validation is the collection and evaluation of data from the process design stage through commercial production, which establishes scientific…
- November 28, 2024Life Sciences industry regulations require validation and change control for Analytical Test Methods used for analysis of product and product…
- November 28, 2024Equipment Validation is comprised of a series of qualifications — including design, installation, operational, and performance qualification. It provides high…
- November 28, 2024Continuous Process Verification is another possible approach to Process Validation. Manufacturing process performance is continuously monitored and evaluated.
- November 28, 2024Computer System Validation is the process used to test, validate, and formally document that a regulated computer-based system does precisely…
- November 28, 2024A new method of computer system validation (CSV) recommended by the U.S. Food and Drug Administration (FDA) to validate software…
- November 28, 2024Commissioning and qualification (C&Q or sometimes CQV) are two distinct steps of validation, usually in the installation or maintenance of…
- November 28, 2024Life Sciences industry regulations require all critical systems and equipment used in the cold chain logistics (packaging, storage, and distribution)…
- November 28, 2024Cleaning Validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active,…
- November 28, 2024Life Science industry regulations require laboratory analytical instruments to be validated and maintained in a validated state throughout the instrument’s…