Industrial Weighing - Validation
Challenged by computerized system validation. The consumer should have access to safe medications, medical devices and services through processes that are understood and controlled, and therefore reproducible. These claims are contained in healthcare regulations and laws worldwide.
According to the WHO, for example, one of its primary tasks is “... to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products...”, and in this connection, to present its regulations for GMP and validation.
In the United States, the general regulations for drugs, food and cosmetics, are set down in CFR 21, Food and Drugs, and relate to the expanded Federal Food and Cosmetic Act. 21 CFR 210/211 describes the 'current Good Manufacturing Practice” (cGMP) for human drugs and, as a quality-control measure, explicitly calls for validation activities for automatic, mechanical and electronic equipment - for example, computer systems - which should be inspected and checked according to a written program designed to assure flawless operation.
In the European Union, great importance is attached to Directives 2001/83/EG and 91/356/EG. The latter describes the EU GMP regulations that are binding for the Member States, and that are interpreted in the EU GMP guidelines and its appendices. The core statement of Annex 11 with regard to computer validation is that if computer-assisted systems initially perform manual activities, neither product quality nor quality assurance should be diminished.
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