deepak mishra

compliance regulatory compliance data integrity 21 cfr part 11 accuracy security electronic data electronic signature electronic records gamp 5 annexure 11 warning letters 483s processing of chromatographic peaks chromatographic peaks hplc integration manual deviations system suitablity acceptance criteria of dissolution dissolution vs disintegration dissolution reserve sample pharmaceuticals change management risk assessment urs performance qualification operational qualification installation qualification design specification functional specification data qualification pharmaceutical annex 11 usp <1058> validation software qualification instrument password audit trail restoration backup good manufacturing practices fda reliability