Professional Documents
Culture Documents
PH 02
PH 02
0utline of Presentation
1 lntroduction - 0one
2 Reulations in the harmaceutical industr]
3 what should we think about when movin versions!
4 0o we need to do erform a full validation!
5 The roject team
6 Testin SAS in our environment
7 lnformal Testin of SAS
8 Trainin the users
9 Conclusions
Project Team
Project leader
Validation/qualification manaer
Validation/qualification consultant
lnformation services reresentative
0racle Clinical reresentative
CARL reresentative
SAS exert
Conclusions
Validation/ualification is now a reulator] requirement in the
harmaceutical industr]
lnformal testin before a new version of SAS is valuable
tests SAS without constraints
tests SAS is ]our own environment
Row we train users in a new version of SAS is imortant if we
want users to:
suort the chane full]
understand how the new version can benefit them
Conclusions
Co-ordinatin the Hiration to SAS V8.2 has so far been a much
more comlex task than l initiall] redicted
The Hajorit] of the documentation in qualif]in SAS in our
environment will alread] have been done when we urade to the
next version
Lnland's chances of qualif]in for the world Cu will deend
heavil] on the la]ers and the manaer. Althouh the riht kind
of suorters is also a ke] factor....