Retrospective validation of a chromatography data system - Part I: Determining the paperwork gap and planning the overall approach

LC GC: Liquid Chromatography, Gas Chromatography

Volumn 16, Issue 10, 1998, Pages 938-943

  Johansson, Per ^a   Wikenstedt, Bengt ^a   McDowall, R D ^a,b  

^a ASTRAZENECA R AND D   (Sweden)

^b MCDOWALL CONSULTING   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 19844379299     PISSN: 08889090     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

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2. P.D. Lepore, Lab. Info. Mngmnt. 17, 283-286 (1992).
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4. Koseisho, Good Laboratory Practice Attachment: GLP Inspection of Computer System (Japan Ministry of Health and Welfare, Pharmaceutical Affairs Bureau, Tokyo, 1988), pp. 157-160.
5. United Kingdom Compliance Program: The Application of GLP Principles to Computer Systems (United Kingdom Department of Health, Good Laboratory Practice, London, Advisory Leaflet Number 1, 1989).
6. Good Manufacturing Practice for Medicinal Products in the European Community, Annex II (Commission of the European Communities, Brussels, 1997).
7. Good Automated Manufacturing Practice Guidelines (International Society for Pharmaceutical Engineering, Tampa, Florida, May 1996).
8. B. Boehm, "Some Information Processing Implications of Air Force Missions 1970-1980," Rand Corp. (Santa Monica, California, 1970).
9. L. Huber, Validation of Computerized Analytical Systems (Interpharm Press, Buffalo, Illinois 1995).
10. R.D. McDowall, "The Use of Work Flow Analysis in the Validation of a Chromatography Data System," paper presented at Computers in Analysis meeting, London, October 1997.
11. Process Validation Guidelines (United States Food and Drug Administration, Washington, D.C., May 1987).
12. Software Test Documentation, IEEE Standard 829-1983 (Institute of Electronic and Electrical Engineers, Piscataway, New Jersey, Software Test Documentation, 1994).
13. R.D. McDowall, LC•GC 16(2), 128-132 (1998).