<s>
Computerized	B-Application
system	I-Application
validation	I-Application
(	O
CSV	O
)	O
(	O
Computerised	O
system	O
validation	O
in	O
European	O
countries	O
,	O
and	O
usually	O
referred	O
to	O
as	O
"	O
Computer	O
Systems	O
Validation	O
"	O
)	O
is	O
the	O
process	O
of	O
testing/validating/qualifying	O
a	O
regulated	O
(	O
e.g.	O
,	O
US	O
FDA	O
21	O
CFR	O
Part	O
11	O
)	O
computerized	O
system	O
to	O
ensure	O
that	O
it	O
does	O
exactly	O
what	O
it	O
is	O
designed	O
to	O
do	O
in	O
a	O
consistent	O
and	O
reproducible	O
manner	O
that	O
is	O
as	O
safe	O
,	O
secure	O
and	O
reliable	O
as	O
paper-based	O
records	O
.	O
</s>
<s>
User	B-General_Concept
Requirements	I-General_Concept
Specification	I-General_Concept
:	O
Specifies	O
required	O
aims	O
of	O
the	O
system	O
.	O
</s>
