컴퓨터화시스템밸리데이션의 적용범위는 PICS규정 내 에서 회사마다 다르게 정할 수 있다 > INNOk 공지게시판

컴퓨터화시스템밸리데이션의 적용범위는 PICS규정 내 에서 회사마다 다르게 정할 수 있다

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댓글 3건 조회 13,284회 작성일 20-05-20 04:02

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PIC/S PI 011-3

21. 전자 기록 및 전자 서명

21.1 문서관리시스템의 중요 법규 요건으로는 법규 규제를 받는 사용자는 사용하는
시스템이 규정된 기간 동안 데이터를 보존할 수 있고, 쉽게 읽을 수 있는 형태로
데이터를 생성하며, 손실 또는 손상으로부터 데이터를 보호 할 수 있음을 밸리데이션을 통해 입증하는 것이다.

21.2 가이던스는 전자 데이터 처리 (EDP) 시스템을 언급하며 데이터를 보호하기 위해
시행되어야 할 여러 우수 시행 방법을 다음과 같이 예시하고 있다.

- 권한있는 자만이 시스템에 접근
- 비밀번호 사용
- 백업 복사본 생성
- 중요한 데이터에 대한 독립적인 검사

- 요구되는 기간 동안 안전하게 데이터 저장
이와 같은 시스템은 또한 다음과 같은 사항에 대한 증명이 요구된다.
- (영구적) 밸리데이션되고 보안이 확보되는 컴퓨터화 시스템의 사용
- (적절한 경우) 시스템적으로 정확하고, 보안이 확보되며 점검기록 기능 사용

21. ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES
21.1 The main requirements here being that the regulated user has validated
the system by proving that the system is able to store the data for
the required time, that the data is made readily available in legible
form and that the data is protected against loss or damage.
21.2 It references electronic data processing (EDP) systems and implies a
number of good practice measures that should be in place to protect the data:
- access by authorised personnel only
- use of passwords
- creation of backup copies
- independent checking of critical data
- safe storage of data for the required time

이전글임상시험용의약품 보관조건 20.05.20
다음글제네릭의약품에 대한 의약품동등성시험자료에 대한 AUDIT TRAIL 제출항목 20.05.20

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William님의 댓글

William 작성일 23-02-06 19:22

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Georgette 작성일 23-03-18 13:18

Robert님의 댓글

Robert 작성일 23-03-26 02:49

INNOK-식의약 GMP,인허가 컨설팅

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