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Volumn 3, Issue 2, 2011, Pages 134-143

A review on computer aided instrument validation

Author keywords

Design qualification; Installation qualification; Operational qualification; Performance qualification; Validation

Indexed keywords

4Q MODEL; ARTICLE; AUTOMATION, COMPUTERS AND DATA PROCESSING; COMPUTER AIDED DESIGN; COMPUTER SYSTEM; DESIGN QUALIFICATION; EVALUATION; INFORMATION PROCESSING; INSTALLATION QUALIFICATION; INSTRUMENT VALIDATION; MODEL; OPERATIONAL QUALIFICATION; PERFORMANCE QUALIFICATION; SYSTEM QUALIFICATION; TOTAL QUALITY MANAGEMENT; V MODEL; VALIDATION FILE; VALIDATION PROCESS; VALIDATION REPORT; VENDOR ASSESSMENT;

EID: 79954566393     PISSN: None     EISSN: 09757384     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (2)

References (14)
  • 2
    • 84865197860 scopus 로고    scopus 로고
    • http://www.labcompliance.com/tutorial/csv
  • 3
    • 84865174751 scopus 로고    scopus 로고
    • http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=261889
  • 5
    • 84865195024 scopus 로고    scopus 로고
    • http://www.articlesbase.com/home-business-articles/computer-system-validation-white-checkentity/checkentitypaper-3257046.html
  • 6
    • 79954479089 scopus 로고    scopus 로고
    • Note
    • Good Computer Validation Practices - Common Sense Implementation [Stokes, Branning, Chapman, Hambloch & Trill. Interpharm Press, USA.
  • 7
    • 84865195025 scopus 로고    scopus 로고
    • http://www.validation-online.net/computer-validation.html
  • 8
    • 79954456211 scopus 로고    scopus 로고
    • General Principles of Software Validation - Final Guidance for Industry and FDA Staff, FDA, CDRH, January
    • General Principles of Software Validation - Final Guidance for Industry and FDA Staff (FDA, CDRH, January 2002)
    • (2002)
  • 9
    • 0028907690 scopus 로고
    • Validation of Computer-Related Systems
    • PDA Technical Report No 18, No.S1
    • PDA Technical Report No 18, ''Validation of Computer-Related Systems'', PDA Journal of Pharmaceutical Science and Technology, 1995 Supplement, Vol. 49, No.S1
    • (1995) PDA Journal of Pharmaceutical Science and Technology , vol.49 , Issue.SUPPL
  • 11
    • 79954457430 scopus 로고    scopus 로고
    • Guidance for Industry: General Principles of Software Validation
    • FDA, June
    • FDA. Guidance for Industry: General Principles of Software Validation. Draft Guidance Version 1.1. June 9, 1997
    • (1997) Draft Guidance Version 1.1 , pp. 9
  • 12
    • 79954514704 scopus 로고    scopus 로고
    • Note
    • WHO Guideline for GMP for Manufacture of Pharmaceutical Products


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.