SAS Views 2001

ls it harder for a harmaceutical coman] to move

from SAS V6.12 to V8.2 than it is for a countr] to
qualif] for the world cu!

Football is a Thinkin Hans 0ame

Ronaldo on his son:
"Re will be called Ronald, because we like oin to Hc0onald's"
0avid 8eckham on his son:
"l would like to have 8rookl]n christened but l'm not sure which
reliion ]et"

who, what, wh]!

0ar] Kenned]
Team Leader Statistics
Project Leader of miration to latest SAS version
Currentl] V6.12, movin to V8.2
wh] choose me!
Ten ]ears SAS exerience and reularl] attend SLu0l/Su0l
Stuid enouh to sa] ]es

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

Reulations in the Pharmaceutical lndustr]

Reulator] requirement 21 CFR Part 11 - Llectronic Sinatures
lt is a 8l requirement that all software/hardware is validated if it is
used to roduce data for a reulator] submission
This oes be]ond the SAS to the validation of the hardware Ci.e.
uhlX box the software will be stored on
Also, how will SAS interact with the other software we use
will we lose functionalit]!
will we have a reduction in erformance!

what Should we Think About when

Hovin Versions!
Aree roject team members
Functional requirements and secifications
lnstallation qualification Cl
Risk assessment
ualification lan
Test strate]
Secif] test cases
Trainin lan
S.0.P.s for validation
Review of validation ever] two ]ears

Hovin Versions is no Loner a Simle Task

with revious versions the miration was erformed in < 1 month
how our aim is to move to SAS V8.2 b] end of Harch 2002!
ls this reall] all necessar]!
8l requirement
Reulator] requirement for electronic sinatures but ma] also
exand to other reulations in the future
0ood business ractice

0o we heed to Perform a Full Validation!

SAS has been a standard in the harmaceutical industr] for man]
]ears
we have man] ]ears exerience in usin SAS at 8.l.
ualification and not Validation
less emhasis on SAS
more emhasis on our hardware and environment
write Risk Assessment to exlain wh]

Project Team
Project leader
Validation/qualification manaer
Validation/qualification consultant
lnformation services reresentative
0racle Clinical reresentative
CARL reresentative
SAS exert

Testin SAS in 0ur Lnvironment

Standard SAS Test Streams
lnformal Testin
Sinle Stud] Test Crun rorams for one stud] and comare
outut between versions
Performance Testin at each 0Pu!
Comatibilit] of SAS 8.2 with 0'C 4.0
Comatibilit] with CARL

Hanaers heed to Alwa]s Remain Positive

Kevin Keean:
"The ood news for hieria is that the]'re two-nil down ver] earl] in
the ame"

Hanaers heed to Kee Calm

Ron Atkinson:
"l never comment on referees and l'm not oin to break the habit
of a lifetime for that rat"

Hanaers heed to be 0ecisive

|imm] Rill:
"0on't sit on the fence Terr], what chance do ]ou think 0erman]
has ot of ettin throuh!"
Terr] Venables:
"l think it's fift]-fift]"

lnformal Testin of SAS

16 users usin V8 for 2 months
8ase rocedures, Stats. Procedures, Lnvironment & 00S
"8l 0uide" to V8
Assess new functionalit]!
what functionalit] is most useful to 8l!
what functionalit] is difficult to understand or imlement!
what tis can we ive new users!
what SAS bus were found!
Testin results ver] ositive on new features

lnformal Testin of SAS CLxamle1

we reularl] save rahs into cataloues usin the 00uT otion
Proc 0lot data=c.test out=c.m]cat,
Plot X'Y,
Run,
when ]ou clear the results window the outut for the rah
within the ermanent cataloue Cc.m]cat is removed as well

lnformal Testin of SAS

lnformal Testin of SAS

lnformal Testin of SAS CLxamle2

The Proc Heans statistics outut now kee the attributes of the
anal]sis variable used
ln version 6.12 the] did not
This otion can be removed b] addin the h0lhRLRlT otion to
the 0uTPuT statement
ln eneral an imrovement but V6.12 rorams ma] roduce
different outut unless amended

Trainin the users

Trainin the users

Football Commentators Rel the Fans to

understand Football!
Trevor 8rookin:
"That's football, Hike, horthern lreland have had several chances
and haven't scored but Lnland have had no chances and scored
twice"
Ron Atkinson:
"Re dribbles a lot and the oosition don't like it - ]ou can see it all
over their faces"

Trainin the SAS users

Hore than 400 SAS users at 8l worldwide
0ifferent levels of SAS exerience
Statisticians
Prorammers
0ata Hanaers
0ifferent levels of interest in SAS
just the outut or how does it calculate the outut!
Lanuae differences

what trainin is most imortant!

Row has the SAS environment chaned Ca lot!!
The 00S S]stem
what chanes will need to be made to old rorams so the]
roduce identical outut in V8!
what features can we use in V8 to seed u our SAS
rorammin!

Row Should the Trainin be 0iven

0emonstration with P.C.
difficult with so man] to train
need lare number of suervisors
Presentation with screenshots + interactive sessions
Lasier to manae
Possibl] less effective
lmortant to break u resentation with tasks C20mins
attention san

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....