Qt Consulting

qt consulting specializes in offering support in relation to regulatory compliance and quality in the pharmaceutical industry. range of services: * quality management systems & gap analysis * process validation * process optimization * shipping validation * equipment qualification * computer system validation * quality risk management * fmea * capa * complaint handling * change control * document control * defining quality plans * defining sampling plans * deviation management * root cause analysis * request ce-mark & export certificates for medical devices * supplier management * iso 13485 (2003, en 2012, 2016) * iso 9001:2015 * iso 14971:2012 * iso 2859:2006 * iso 3951:2013 * directive 98/79/eec ; 93/42/eec ; * fda 21 cfr 820 * fda 21 cfr 211 * fda 21 cfr 210 * fda 21 cfr part 11