이매스교육 및 공지사항
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 |
•
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