Validation of computer systems: Practical testing of a standard lims

Pharmaceutica Acta Helvetiae

Volumn 72, Issue 6, 1998, Pages 343-348

  Friedli, Daniel ^a   Kappeler, Wolfgang ^b   Zimmermann, Susanne ^b  

^a Spirig AG   (Switzerland)

^b Cilag AG   (Switzerland)

Author keywords

Computer systems; LIMS; Validation; Verification

Indexed keywords

ARTICLE; AUTOMATION; COMPUTER SYSTEM; DATA ANALYSIS; DRUG INDUSTRY; VALIDATION PROCESS;

CLINICAL LABORATORY INFORMATION SYSTEMS; COMPUTER SYSTEMS; DRUG INDUSTRY; SOFTWARE VALIDATION;

EID: 0032005924     PISSN: 00316865     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0031-6865(97)00032-0     Document Type: Article

References (9)

1. APV-Fachgruppe Informationstechnologie, 1996. APV - Computerunterstützte Systeme. Pharm. Ind. 58 (7), 590-598.
2. Beizer, B., Van Nostrand R., 1995. Software Testing Techniques. New York.
3. FDA, 1987. Guidelines on General Principles of Process Validation. 5600 Fisher Lane. Rochville, Maryland 20857.
4. GAMP Good Automated Manufacturing Practice, 1996. Pharmaceutical Industry Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture, ISPE.
5. Huber, L., 1996. Validierung Computergesteuerter Analysensysteme: Ein Leitfaden für Praktiker. Springer Verlag, Berlin, Heidelberg, New York.
6. Huber, L., 1996b. Validierung Computerunterstützter Systeme. Pharm. Ind. 58 (10), 935-940.
7. PMA, CSVC, 1986. Validation Concepts for computer System, Validation in the Manufacture of Drug Products. Pharm. Technol. 10(5), 24-34
8. Teuchert, V., 1996. Prozessleitsysteme in der Pharmaproduktion. Pharm. Ind. 58 (10), 930-934.
9. Wolf, H., 1996, Die Anwendung der GLP-Grundsätze auf computergestützte Systeme (OECD 1995), Deutsche Übersetzung. Konsenspapier - GLP u. DV/306. OECD-Originaldokument: OCDE/GD, 1995, p. 115.