Paper Info
Title
A Method for Ensuring Consistency of Software Design Information in Retrospective Computer Validation
Abstract
This paper proposes a method for ensuring consistency of software design information when we conduct Retrospective Computer Validation (RCV). RCV is proof tasks that quality of in-service software related to drug manufacturing (DMSW) is adequate. When we conduct RCV in first time, we show design adequacy of DMSW to collect existing documents and running records. When we remodel DMSW, we show design adequacy to develop new documents and conduct enough tests. It is difficult to ensure consistency because there are some differences of description items and fineness between existing and new documents. This problem made RCV enforcement difficult. We will solve this problem to conduct following countermeasures; 1) define document architecture, 2) define description items and contents in every document, and 3) implement database that manages description items and relationships between documents. Consequently, we can clarify affected range, when some remodeling occurs. To modify design information in affected range, we can maintain adequacy of design information of DMSW. As the result, we can conduct RCV smoothly.
Year
DOI
Venue
2008
10.1007/978-3-540-85565-1_124
KES (2)
Keywords
Field
DocType
new document,document architecture,software design information,in-service software,rcv enforcement,ensuring consistency,retrospective computer validation,affected range,design adequacy,description item,design information,production system,software design
Countermeasure,Design information,Software design,Computer science,Software,Enforcement,Document architecture,Database
Conference
Volume
ISSN
Citations 
5178
0302-9743
0
PageRank 
References 
Authors
0.34
3
3
Name
Order
Citations
PageRank
Masakazu Takahashi194.92
Satoru Takahashi24015.01
Yoshikatsu Fujita3149.36