Validation
Computerized System Validation (CSV)
Computerized System Validation (CSV) according to Good Automated Manufacturing Practice (GAMP) guidelines requires users and vendors to work together to understand the responsibilities for the Validation process. It provides confirmation and objective evidence that software specifications comply with users’ needs and intended uses.
Equipment Validation
Equipment Validation includes a number of Qualifications, including Design, Installation, Operational and Performance, which provide a high degree of assurance for the consistent, expected operation of industrial equipment. Operation parameters and environment, as well as documented routine maintenance and ongoing performance controls, contribute to the maintenance of equipment in a permanently Validated state.
Good Automated Manufacturing Practice (GAMP)
A system for the production of quality equipment that uses the concept of prospective validation according to a life cycle model. Specially designed to help suppliers and users in the pharmaceutical industry. GAMP practices are used worldwide by companies and their suppliers and are widely supported by regulatory organizations (evidenced by the global regulatory contribution and referred to in various guidance documents).
Design Validation
Design validation is the finding with objective evidence that the specifications of a device or equipment comply with the needs of the user and an intended use. This can be applied to medical devices as well as equipment used in the production of medicinal products. Design validation may include actual or simulated use tests and may require software validation and risk analysis.
