PMID- 9556435
OWN - NLM
STAT- MEDLINE
DCOM- 19980423
LR  - 20191102
IS  - 0031-6865 (Print)
IS  - 0031-6865 (Linking)
VI  - 72
IP  - 6
DP  - 1998 Feb
TI  - Validation of computer systems: practical testing of a standard LIMS.
PG  - 343-8
AB  - In recent years the introduction of computer systems for data handling in the 
      pharmaceutical industry has increased. A standard LIMS (laboratory information 
      management system) is software commercially available from different suppliers 
      not only to facilitate data handling in laboratories but also to cover 
      GMP-requirements. Computer systems introduced in GMP-areas of pharmaceutical 
      companies have to be validated. For a standard LIMS, the general validation of 
      the program is performed by the supplier. Nevertheless, the user is always 
      required to cover all phases of a validation. The objective of this paper is to 
      discuss suitable test procedures for the most critical functions of a standard 
      LIMS needed during the verification step of the validation process.
FAU - Friedli, D
AU  - Friedli D
AD  - Spirig AG, Froschacker, Egerkingen, Switerzerland. szimmerm@cilch. jnj.com
FAU - Kappeler, W
AU  - Kappeler W
FAU - Zimmermann, S
AU  - Zimmermann S
LA  - eng
PT  - Journal Article
PL  - Switzerland
TA  - Pharm Acta Helv
JT  - Pharmaceutica acta Helvetiae
JID - 0401134
SB  - IM
MH  - Clinical Laboratory Information Systems/*standards
MH  - Computer Systems/*standards
MH  - Drug Industry/*standards
MH  - *Software Validation
EDAT- 1998/04/29 00:00
MHDA- 1998/04/29 00:01
CRDT- 1998/04/29 00:00
PHST- 1998/04/29 00:00 [pubmed]
PHST- 1998/04/29 00:01 [medline]
PHST- 1998/04/29 00:00 [entrez]
AID - S0031686597000320 [pii]
AID - 10.1016/s0031-6865(97)00032-0 [doi]
PST - ppublish
SO  - Pharm Acta Helv. 1998 Feb;72(6):343-8. doi: 10.1016/s0031-6865(97)00032-0.