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Edu-talk

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    FDA 21 CFR Part 11 최근까지의 규정 및 지침 내용 목차 비교

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규정과 가이드라인 목차내용 비교 테이블
실험실에서 Part 11을 준비해야 한다면 최소한 아래의 내용을 파악하고 자세하게 이해할 필요가 있다.
FDA Title 21 CFR Part 11:Electronic Records; Electronic Signatures; Final Rule (1997)
Electronic Records: Electronic Signatures – Scope and Application (2003)
Guidance for Industry Computerized Systems Used in Clinical Investigations (2007)
           Subpart A – General Provisions[일반조항]
1.      Scope[범위]
2.      Implementation[이행]
3.      Definitions[정의]
         Subpart B – Electronic Records[전자기록]
1.      Controls for closed systems[닫힌시스템통제]
2.      Controls for open systems[열린시스템통제]
3.      Signature manifestations[서명표시]
4.      Signature/record linking[서명/기록연결]
        Subpart C – Electronic Signatures[전자서명]
1.      General requirements[일반조건]
2.      Electronic signatures and controls[전자서명과통제]
3.      Controls for identification codes/passwords[ID/PW통제]
A. Overall Approach to Part 11 Requirements
B. Details of Approach – Scope of Part 11
1. Narrow Interpretation of Scope
2. Definition of Part 11 Records
C. Approach to Specific Part 11 Requirements
1. Validation
2. Audit Trail
3. Legacy Systems
4. Copies of Records
5. Record Retention
 
RECOMMENDATIONS
A. Study Protocols
B. Standard Operating Procedures
C. Source Documentation and Retention
D. Internal Security Safeguards
1. Limited Access
2. Audit Trails
3. Date/Time Stamps
E. External Security Safeguards
F. Other System Features
1. Direct Entry of Data
2. Retrieving Data
3. Dependability System Documentation
4. System Controls


참고문서 목록

•        United States Food and Drug Administration (FDA), General Principal of Software Validation: Final Guidance for Industry and FDA Staff, 2002

•        United States Food and Drug Administration (FDA), Industry Guide (draft): Computerized Systems Used in Clinical Investigations, 2009

•        United States Food and Drug Administration (FDA),  Code of Federal Regulations, Title 21, Food and Drugs, Part 11 "Electronic Records; Electronic Signatures; Final Rule; Federal Register 62 (54), 13429-13466, 1997

•        FDA, Guidance for Industry, 21 CFR Part 11, Electronic Records, Electronic Signatures: Scope and Applications, 2003

•        Pharmaceutical Inspection Convention, January 2002,, Good practices for computerized systems in regulated ‘GxP’ environments. 

•        GAMP Good Automated Manufacturing Practice, Guide for Validation of Automated Systems in Pharmaceutical Manufacture, Version 3, March 1998, Version 4, 2001, Version 5 2008

•        Parenteral Drug Association (PDA), Validation and qualification of computerized laboratory data acquisition systems (LDAS), Technical paper 31, 2000 

•        Annex 11 of the European GMP Directive: Computerized Systems, 2011




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