PMID- 9556436
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 a customized LIMS.
PG  - 349-56
AB  - The advantages of customized Laboratory Information Management's Systems (LIMS) 
      are their focus on the special aspects of their users' needs. Differences in the 
      research and development or production chain in the individual organizations lead 
      to an increase of interest in customized systems. Usually, also for customized 
      systems, the core software is commercially available. The individual application 
      modules as the Customized part of the LIMS are the most critical elements within 
      the validation process. The topic of this paper is to give an example of the 
      validation of a customized analytical LIMS. Validation of complex computerized 
      systems guarantees the intended use and is therefore an unavoidable requirement 
      of authorities. The audit of the supplier of the individual programmed modules, 
      the user requirement specifications and the acceptance testing and results, 
      respectively, on the software are of special interest within a customized LIMS. 
      The hardware suitability and the principal processing routines are also a very 
      important part of the whole validation process, but they will not be discussed in 
      detail in this paper.
FAU - Bund, C
AU  - Bund C
AD  - Novartis Pharma AG, Basel, Switzerland. christian.bund@pharma. novartis.com
FAU - Heinemann, G W
AU  - Heinemann GW
FAU - Jager, B
AU  - Jager B
FAU - Trinkler, M
AU  - Trinkler M
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  - 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 - S0031686597000332 [pii]
AID - 10.1016/s0031-6865(97)00033-2 [doi]
PST - ppublish
SO  - Pharm Acta Helv. 1998 Feb;72(6):349-56. doi: 10.1016/s0031-6865(97)00033-2.