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Guidelines computerised systems

Japanese Ministry of Health and Welfare (1993), Guideline on Control of Computerised Systems in Drug Manufacturing, Manual for Control of Computerised Systems in GMP, Audit Manual for Manufacturers of Pharmaceutical Product with Computer Systems. [Pg.43]

European Commission. Eudralex volume 4 EU guidelines to good manufacturing practice medicinal products Jot human and veterinary use - Annex 11 Computerised systems. 2010, pp 1-5. http // ec.europa.eu/health/files/eudralex/vol-4/annexl 1 01-201 l en.pdf. Accessed 4 Sept 2014... [Pg.768]

Quality assurance of the analytical process is well established. However, in common with other safety related disciplines and applications, there is a concern about the reliability of computerised systems and the lack of generally accepted guidelines. These concerns are being addressed within the multi disciplinary DTI sponsored research project MORSE. West Middlesex hospital is one of the participants in this project. [Pg.85]

See other pages where Guidelines computerised systems is mentioned: [Pg.569]    [Pg.111]    [Pg.188]    [Pg.764]    [Pg.77]    [Pg.811]    [Pg.50]    [Pg.219]   
See also in sourсe #XX -- [ Pg.338 ]



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