세피안 - 솔루션 스토리

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??/??/????/???/???/???? ??? ??? GMP, R&D, ?? ??? ??? – SmartWorx 2.0/Pharma

? GMP ????

? 21 CFR Part11

? CRO ??

? ???? ?? ??

? PMS

? R&D ???? ??

? ??? ?? ? ???? ??

??/??/????/???/???/???? ???? ???? ?? ??????.

??? ? ???? ??? ???? ??? ???? ?? ???? ???? ?? ?? ??? ? ?? ??????.

Step1. ?? ??? ?????

?? ???? ??? ????

??? ??/??/????/???/???/???? ???? GMP/R&D ???? ? ????? ??? ???????

????, ????, ????, ????, ???, ????, ????, ????, ????, ???? ? ?? ??? ??/?? ???? ??? ?????? ???? ECM ? ?? ???? ?? ??? GMP ????? ???? ?????? ????? ?? ???? ????? ???????.

Step2. ???? ?? ???!?? ??? ?? ?? ??

??? ?????? 2004? ?? ??? ???? ???? EDMS? ??? ?? ????, ????, ????, ???, ????, ????, ????, ????, ???? ?? R&D ? GMP ???? ?????? ???????.

??, ??? ?????? ???? ???? ?????????? MGCP(Microsoft Gold Certified Partner)? EMC? Velocity Premier Partnership, ISV/OEM Partnership? ??? ???? ??. ?, ??? ??? ??? ??? ???? ???? ???? ??? ? ?? ??? Know-how? ?? ?? ????.

?????

?? ?? ??? Best Practice? ???? ??? ??? ??? ????, ??? ????? ??? ? ?? ??

? ?? ?????

??? ??? ??? ???. ????? ???????? ??? ?????? SmartWorx 2.0/Pharma? ???? ????.

????????, “?????????????” [?????]

???? ‘GMP R&D’ ???????? [????]

?????, ?????????????? [????]

????????, ???????? SW ?? [??????]

???? ‘???? ??’ ??? ?? SW ?? [????]