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OPM Product Development -Concept to Release
Demo Script (Internal)
Copyright Oracle Corporation, 2003. All rights reserved.
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!a"le of Contents
Life Sciences - Concept to Release [EDUM0275] 22-Oct-2004..................... ............... .............. .............. ....i
OPM Product Development - Concept to Release......................................................................................................1Enable Formula Version Control................................................................................................................................5
Verif!Enable Profile Options for Formula!Recipe "or#flo$s and ERE% &pproval for user' Process(Ops...........)Create a Pilot Routin* +For C,emicals Demo onl...................................................................................................Verif Default /ab Profile........................................................................................................................................11Verif!Enable Profile Options for Formula!Recipe "or#flo$s and ERE% &pproval for user' Process..................10%tart Demo from ads$eb...........................................................................................................................................1Create a 2e$ Formula..............................................................................................................................................15%etup 3ec,nical Data................................................................................................................................................1)&nal4e Formula sin* %imulator...........................................................................................................................06Re7uest &pproval for 8eneral se...........................................................................................................................00&pprove Formula %tatus C,an*e..............................................................................................................................09Create a 2e$ Formula Version.................................................................................................................................0Vie$ Formulas in Formulator "or#benc,...............................................................................................................0:%cale Formula!Version..............................................................................................................................................0)Re7uest &pproval for 8eneral se...........................................................................................................................0&pprove Formula %tatus C,an*e..............................................................................................................................96Create Routin*!Version to &ccommodate %caled Formula......................................................................................91Establis, Routin* %tep-Dependencies usin* Routin* Desi*ner...............................................................................99Create 2e$ Recipe from &pproved Formula!Routin*!Operation............................................................................9:&pprove Recipe %tatus C,an*e.................................................................................................................................9Create a Recipe Validit Rule...................................................................................................................................6&pprove Recipe Validit Rule %tatus C,an*e..........................................................................................................0Flo$c,art..................................................................................................................................................................
Copyright Oracle Corporation, 2003. All rights reserved.
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O# rod$ct %evelop&ent - Concept to Release
Document Control
Date Owne !pp
Release
"esion C#an$e Refeence
10-Dec-0669 ;ruce.
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3,is script maps to t,e follo$in* ;usiness Flo$ solutions'
Concept to Release
Related Documents
,ttp'!!*lobal?c,an*e.oraclecorp.com!demodocs@=ndustr Documentation Folder @ %aved %earc,- P,arma and /ife %ciences Demodocs - &ll
OPM Aualit Mana*ement - 2e$ Product Aualit Mana*ement Development
Demo &acround ('or *i$e Sciences)
&s ne$ products become ever more comple?> re*ulation more onerous and t,e suppl c,ainincreasin*l *lobal> ac,ievin* e?cellence in manufacture and suppl is critical to or*ani4ationalsuccess.
Re%&cin$ t#e po%&ct %e'elop(ent c)cle
On avera*e> p,armaceutical companies invest B566 million and close to 1 ears to brin* asin*le ne$ dru* from concept to release. =t is critical to retain patent protection for mar#etin*and amorti4ation of t,e initial investment b reducin* t,e time bet$een t,e initial dru* discoverand t,e approval of t,e ne$ dru*.
Sec&e eseac# an% %e'elop(ent in'est(ents
=nformation infrastructure is #e to capturin* and e?c,an*in* critical researc, and developmentdata. Researc,ers need to spend more time on dru* discover t,an on information mana*ement.&n inte*rated information tec,nolo* sstem is needed t,at follo$s c8MP and 8/P practices.
3,e solution needs to provide t,e documentation t,at leads to earl product validation.
S&'i'e clinical tails
Onl five percent of ne$ dru*s survive all t,ree p,ases of clinical trials. Manufacturers mustcope $it, t,e ,i*, costs of process safet> total 7ualit> and procedural comple?ities associatedto stud desi*n> randomi4ation> labelin*> tracin*> manufacturin*> and pac#a*in* clinical trialsamples. 3,e process re7uires a dedicated infrastructure to mana*e a sample from formulationt,rou*, administration and clinical data capture> to final stora*e as evidence.
*ilot *o%&ction Si(&lation
&t completion of t,e clinical trials> t,e pilot run provides t,e manufacturin* en*ineerin*information needed to optimi4e desi*n for manufacture and desi*n for assembl. =n man cases>pilots are run durin* t,e clinical trial p,ase to provide t,e information needed for scale-up to t,efull production run.
Scale-&p to +&ll *o%&ction R&n
Copyright Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to Releaseage 2
http://globalxchange.oraclecorp.com/gxchange/page?_pageid=1701,1703&_dad=gxchange&_schema=PHPhttp://globalxchange.oraclecorp.com/pls/gxchange/ats_urldeeplink.loadfolder?p_folderid=3481071&p_siteid=1http://globalxchange.oraclecorp.com/gxchange/page?_pageid=1701,1703&_dad=gxchange&_schema=PHPhttp://globalxchange.oraclecorp.com/pls/gxchange/ats_urldeeplink.loadfolder?p_folderid=3481071&p_siteid=1 -
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Man commerciall important products $ill face *eneric competition $it,in t,e ne?t five ears.Products $it, a**re*ate sales of over B06 billion in t,e ear 0666 ,ave patent e?pirationsbet$een 0666 and 0665.
Defense a$ainst $eneics
8eneric dru*s no$ account for appro?imatel ) of all p,armaceutical prescriptions> up fromabout 19 in 16 and 1 in 1. Mar#et penetration b *enerics ,as become increasin*lrapid. Preparation for reformulation> repositionin*> and line e?tension is essential forprofitabilit.
Retie(ent fo( (aetplace
/a$ ultimatel determines t,e life ccle for a p,armaceutical product. =n t,e nited %tates> t,edate of approval of *eneric competitors is directl tied to patent e?piration for man importantp,armaceuticals. %ome .%. p,armaceutical patents can be e?tended to recover time lost in t,ere*ulator approval process. Mar#et e?clusivitdesi*ned b t,e .%. Con*ress to provideincentives for t,e development of ne$ dru*scan also e?tend product life independent of patent
protection. 3,e statutor basis for approval of *eneric products ma also prevent approval oft,ese products even $,ere patents and mar#et e?clusivit do not appl.
/#e Entie *#a(ace&tical Life C)cle
Se3&ence !cti'it) Sta$e
1. Candidate dru* DEVE/OPME23
0. Researc, and development DEVE/OPME23
9. Clinical trials DEVE/OPME23
4. *ilot ROLL-OU/
5. Scale-&p ROLL-OU/
. La&nc# ROLL-OU/
). Process!product improvement M&3R=3
. /ine e?tensions M&3R=3
. Patent e?pir M&3R=3
16. Defense a*ainst *enerics DEFE2%E
11. Retirement from mar#etplace DEFE2%E
3,is scenario be*ins $it, activit G at t,e be*innin* of t,e rollout sta*e. 3,is sta*e is after t,ep,armaceutical product ,as passed initial clinical trials> and plannin* ,as started for pilot andfull-scale production in preparation for t,e date $,en 2D& approval is *ranted. =n t,is scenario>t,ere are no re7uirements to provide special product ,andlin*!trac#in* capabilities for supportin*blind or double blind studies> as t,ere $ould ,ave been durin* t,e clinical researc, p,ases.
Pre Demo Steps (Optional)
Copyright Oracle Corporation, 2003. All rights reserved.
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)na"le *or&$la +ersion Control
Enale +o(&la "esion Contol
1. /o* into Oracle &pplications Portal
Field Life Sciences-Pharmaceuticals Chemicals
sername Process(ops Process(ops
Pass$ord "elcome "elcome
Responsibilit Product Development %ecuritMana*er
Product Development %ecuritMana*er
0. Auer Or*ani4ation Parameters for PR1
+2 Or*ani4ation Parameters
+= Find
Enter Criteria
Field Life Sciences-Pharmaceuticals Chemicals
Or*ani4ation PR1 PR1
+; Find
9. Enable Formula Version Control for Or*ani4ation PR1
+3 Formula
Field Life Sciences-Pharmaceuticals Chemicals
Version Control es es
+= %ave> if c,an*e made.
+= Close Form
. Auer Or*ani4ation Parameters for /ab Or*ani4ation
+2 Or*ani4ation Parameters
+= Find
Enter Criteria
Field Life Sciences-Pharmaceuticals Chemicals
Copyright Oracle Corporation, 2003. All rights reserved.
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Or*ani4ation /&1 /&0
+; Find
5. Enable Formula Version Control for /ab Or*ani4ation
+3 Formula
Field Life Sciences-Pharmaceuticals Chemicals
Version Control es es
+= %ave> if c,an*e made.
+= Close Form
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+erify)na"le rofile Options for *or&$laRecipe /orflo1s and)R)S Approval for $ser rocessOps
"eif),Enale *ofile Options fo +o(&la,Recipe 1oflows an%
ERES !ppo'al fo &se *ocess6OpsDisclaimer' Please note t,at t,e &D% E-Records and "or#flo$ event profile options andrelated setup $ere created as a demonstration solution to allo$ %Cs to 7uic#l enable anddisable t,e events> and s,ould not be portraed to prospects as a standard part of t,eapplications or as an implementation e?ample.
:. %$itc, Responsibilit
Field Life Sciences-Pharmaceuticals Chemicals
Responsibilit Process En*ineer Process En*ineer
). Auer t,e Profile Options for Formula!Recipe "or#flo$s and ERE% &pproval
+2 Ot,ers @ Profile Options
Auer b E?ample
Field Life Sciences-Pharmaceuticals Chemicals
Profile 2ame &D%P &D%P
/ist of profile options $ill be displaed.
. Verif!Enable t,e Profile Options for Formula!Recipe "or#flo$s and ERE% &pproval
Verif!C,an*e t,e ser Value for t,e profile options
Field Life Sciences-Pharmaceuticals Chemicals
Profile 2ame &D%P'8MD ERE% Formula%tatus C,an*e &pproval
&D%P'8MD ERE% Formula%tatus C,an*e &pproval
ser Value es es
Profile 2ame &D%P'8MD ERE% Recipe %tatusC,an*e &pproval &D%P'8MD ERE% Recipe%tatus C,an*e &pproval
ser Value es es
Profile 2ame &D%P'8MD ERE% RecipeValidit %tatus C,an*e &pproval
&D%P'8MD ERE% RecipeValidit %tatus C,an*e&pproval
Copyright Oracle Corporation, 2003. All rights reserved.
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ser Value es es
+= %ave
+= Close Form
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Create a ilot Ro$ting 6*or Che&icals %e&o only7
Ceate a *ilot Ro&tin$ +o C#e(icals De(o Onl)8
Perform t,is step onl for t,e c,emicals industr demo. & pilot routin* for t,e item!recipe
used in t,is demo $ill be seeded in t,e ne?t release.
. Find an e?istin* routin* to cop
+2 Process Routin*s
%elect or*ani4ation
Field Chemicals
Or*ani4ation PR1
+= Find
Field Chemicals
Routin* ! Version 9161 ! 1
+; Find
3,e routin* details are displaed.
16. Cop t,e routin* to create a ne$ one
Place t,e cursor in t,e top section of t,e screen +i.e.' clic# in t,e routin* field
+= 2e$
Clic# on t,e *reen H at t,e top of t,e screen to create a ne$ record
+M Edit @ Duplicate @ Record &bove
C,an*e t,e name of t,e routin*
Field Chemicals
Routin* 9161-P=/O3 Ior name of ourc,oice@
Version 1 or uni7ue version
+= %ave
2otice t,at t,e status of t,e routin* is 2e$.
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11. &pprove Routin*
+M &ctions-@ C,an*e %tatus
%elect ne$ status
Field Chemicals
C,an*e %tatus 3o &pproved for 8eneral se
+; OJ
Routin* status c,an*es to K&pproved for 8eneral seK.
+= Close Form
10. /o*out
E?it Oracle &pplications
+L /o*out
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+erify %efa$lt La" rofile
"eif) Defa< La *ofile
19. /o* into Oracle &pplications Portal
Field Life Sciences-Pharmaceuticals Chemicals
sername process process
Pass$ord $elcome $elcome
Responsibilit %stem &dministrator %stem &dministrator
1. Verif Profile
+2 Profile @ %stem
Enter searc, criteria
Field Life Sciences-Pharmaceuticals Chemicals
ser PROCE%% PROCE%%
Profile 8MD' Default /ab Or*ani4ation 8MD' Default /abOr*ani4ation
+; Find
%elect lab or*ani4ation
Field Life Sciences-Pharmaceuticals Chemicals
ser Value /&1 /&0
+; OJ
+= Close Form
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+erify)na"le rofile Options for *or&$laRecipe /orflo1s and)R)S Approval for $ser rocess
"eif),Enale *ofile Options fo +o(&la,Recipe 1oflows an%
ERES !ppo'al fo &se *ocessDisclaimer' Please note t,at t,e &D% E-Records and "or#flo$ event profile options andrelated setup $ere created as a demonstration solution to allo$ %Cs to 7uic#l enable anddisable t,e events> and s,ould not be portraed to prospects as a standard part of t,eapplications or as an implementation e?ample.
15. %$itc, Responsibilit
Field Life Sciences-Pharmaceuticals Chemicals
Responsibilit Formulator Formulator
1:. Auer t,e Profile Options for Formula!Recipe "or#flo$s and ERE% &pproval
+2 Ot,ers @ Profile Options
Auer b E?ample
Field Life Sciences-Pharmaceuticals Chemicals
Profile 2ame &D%P &D%P
/ist of profile options $ill be displaed.
1). Verif!Enable t,e Profile Options for Formula!Recipe "or#flo$s and ERE% &pproval
Verif!C,an*e t,e ser Value for t,e profile options
Field Life Sciences-Pharmaceuticals Chemicals
Profile 2ame &D%P'8MD ERE% Formula%tatus C,an*e &pproval
&D%P'8MD ERE% Formula%tatus C,an*e &pproval
ser Value es es
Profile 2ame &D%P'8MD ERE% Recipe %tatusC,an*e &pproval &D%P'8MD ERE% Recipe%tatus C,an*e &pproval
ser Value es es
Profile 2ame &D%P'8MD ERE% RecipeValidit %tatus C,an*e &pproval
&D%P'8MD ERE% RecipeValidit %tatus C,an*e&pproval
Copyright Oracle Corporation, 2003. All rights reserved.
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ser Value es es
+= %ave
+= Close Form
9f *e De(o Steps co(plete: $oto tas ;
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Start %e&o fro& ads1e"
Stat De(o fo( a%swe
1. +L #ttp,,a%swe.oaclea%s.co(
Opens &D%"E; ,ome pa*e
1. +L &D% /aunc,pad
%elect Mac#ine +/OV
%elect 9nstance+/OV
+; /aunc, Demo
Opens &D% /aunc,pad Portal pa*e
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Create a 9e1 *or&$la
Ceate a ew +o(&la
06. /o* into Oracle &pplications Portal
Field Life Sciences-Pharmaceuticals Chemicals
sername process process
Pass$ord $elcome $elcome
Responsibilit Formulator Formulator
ote 3,ere are re*ulations re*ardin*t,e ratio bet$een t,e 7uantitused to produce a dru* durin*clinical trials and t,e full-scale
production 7uantit +i.e.commercial production 7uantitcannot be more t,an 5 times t,e7uantit used to produce productfor clinical trials. 3,e RDFormula produces 066 J8M. "e$ill start $it, t,is formula andscale to 1666 J8M.
2!&
01. Find an e?istin* formula to cop
+2 Formulas
Field Life Sciences-Pharmaceuticals Chemicals
Or*ani4ation /&1 /&0
+= Find
Field Life Sciences-Pharmaceuticals Chemicals
Formula ! Version 961-RD ! 1 9161-RD ! 0
+; Find
3,e formula details are displaed. 2otice t,at Nscalin* allo$ed is c,ec#ed for t,isformula. 3,e default tab is t,e Products tab> $,ic, displas t,e product+s for t,eformula.
+3 ;-products
2o b-products are associated $it, t,is formula.
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+3 =n*redients
3,e in*redient information is displaed.
00. Cop t,e formula to create a ne$ one
Place t,e cursor in t,e top section of t,e screen +i.e.' clic# in t,e formula version field
+= 2e$
Clic# on t,e *reen H at t,e top of t,e screen to create a ne$ record
+M Edit @ Duplicate @ Record &bove
C,an*e t,e name of t,e formula
Field Life Sciences-Pharmaceuticals Chemicals
Formula 961-P=/O3 Ior name of our
c,oice@
9161-P=/O3 Ior name of our
c,oice@
Version 1 or uni7ue version 0 or uni7ue version
+= %ave
2otice t,at t,e status of t,e formula is 2e$.
se t,e scroll bar at t,e bottom of t,e in*redient details to s,o$ more in*redientinformation
Clic# on t,e first in*redient line
Field Life Sciences-Pharmaceuticals Chemicals
=n*redient 61 9061
C,an*e t,e 7uantit for t,e in*redient line
Field Life Sciences-Pharmaceuticals Chemicals
Auantit . 1
+= %ave
2ote' ",en version control is enabled for formulas> as lon* as t,e status of t,e formulais N2e$> ou can continue to c,an*e t,e details of t,e formula $it,out creatin* a ne$version.
Close Form
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Set$p !echnical %ata
Set&p /ec#nical Data
09. %etup a 3ec,nical Parameter
3ec,nical parameters define t,e formula properties t,at must be measured durin* formulaanalsis. =n t,is e?ample> $e are s,o$in* an e?istin* tec,nical parameter to ,elp streamlinet,e demonstration.
+2 3ec,nical Data @ 3ec,nical Parameters
+= Find
Enter Criteria
Field Life Sciences-Pharmaceuticals Chemicals
Parameter PO3E2C %3RE283L
ote & tec,nical parameter forPO3E2C is displaed. 2oticet,at t,e data tpe is "ei*,t+percent of total $ei*,t and t,eunit of measure is +percent.For t,is tpe of data tpe> a validran*e and decimal precision isdefined. For PO3E2C t,e value
can be from 6 to 166 and ,as aprecision of di*its to t,e ri*,t oft,e decimal point.
& tec,nical parameter for%3RE283L is displaed.2otice t,at t,e data tpe is"ei*,t +percent of total$ei*,t and t,e unit of measureis +percent. &lso notice t,atit ,as 7ualit test associated$it, it. For t,is tpe of data
tpe> a valid ran*e and decimalprecision is defined. For%3RE283L t,e value can befrom 6 to 166 and ,as aprecision of di*its to t,e ri*,tof t,e decimal point
+; Find
%elect t,e list of values for Data 3pe to see t,e ot,er tpes data tpes for tec,nicalparameters.
Discuss t,e ot,er data tpes'
E?pressions' E?pressions are calculations t,at can be defined b usin* ot,er tec,nicalparameters as values.
%pecific 8ravit' Densit is a tec,nical parameter t,at is seeded for eac, laboratoror*ani4ation. 3,e OM for densit in Vision is N%pecific 8ravit. %pecific 8ravit isdefined as t,e ratio bet$een $ei*,t and volume> as relative to t,is same ratio of $ater at
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:6 de*rees F +e.*. t,e specific *ravit of $ater at :6 de*rees F 1. Densit is are7uired parameter for all laboratories> as t,is parameter is used to perform conversionsfrom mass units of measure to volume units of measure.
Ot,er data tpes include' C,aracter> 2umeric> Validation /ist> ;oolean and Volume.
+= Close Form
0. %etup 3ec,nical Parameter %e7uences +Optional
+2 3ec,nical Data @ 3ec,nical Parameter %e7uences
+= Find
Enter Criteria
Field Life Sciences-Pharmaceuticals Chemicals
Or*ani4ation /&1 /&0
+; Find
3,e tec,nical parameter se7uences for t,e above or*ani4ation are displaed. 3,eimportant t,in* about t,ese se7uences is t,at an tec,nical parameter t,at is dependenton anot,er tec,nical parameter> must be se7uenced after t,e one $it, $,ic, it ,as adependenc +i.e. =f parameter & is defined as an e?pression t,at uses parameter ;> t,enparameter ; must be se7uenced suc, t,at it is in t,e list before parameter &. 3,etec,nical parameter for Densit +N%pecific 8ravit in Vision must al$as be t,e firstone in t,e list.
+= Close Form
05. %etup =tem 3ec,nical Data +Optional
+2 3ec,nical Data @ =tem 3ec,nical Data
+= Clear Record
+= Find - 3,e flas,li*,t icon
Enter Criteria
Field Life Sciences-Pharmaceuticals Chemicals
Or*ani4ation /&1 /&0
+; Find
Copyright Oracle Corporation, 2003. All rights reserved.
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3,e item tec,nical data for t,e in*redients $it,in t,e lab or* are displaed. Eac,in*redient t,at is included in a formula is *iven a value for eac, of t,e tec,nicalparameters. 3,ese values are t,en used to perform analsis for t,e formula.
Values for tec,nical parameters can also be derived from sample results in OPMAualit Mana*ement. 3o use suc, values> t,e user must specif a batc, or a lot to beused durin* formula analsis and t,e batc, or lot must ,ave a sample and results for atest t,at is assi*ned to a tec,nical parameter.
Close =tem 3ec,nical Data Form
Copyright Oracle Corporation, 2003. All rights reserved.
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Analy:e *or&$la ;sing Si&$lator
!nal)>e +o(&la Usin$ Si(&lato
0:. 2avi*ate to %imulator
+2 %imulator
+= Find
Field Life Sciences-Pharmaceuticals Chemicals
Formula!Version 961-P=/O3 Ior name of ourc,oice from above@
9161-P=/O3 Ior name of ourc,oice from above@
+; Find
Field Life Sciences-Pharmaceuticals Chemicals
ote Formula version created durin*t,is demo is displaed. %ee t,epotenc information and materialcost information for t,e formula.
Formula version created durin*t,is demo is displaed. %ee t,estren*t, information for t,eformula.
0). %,o$ t,e abilit to do K$,at-ifK analsis b c,an*in* t,e 7uantit for one of t,e in*redients
Clic# in t,e 7uantit field for t,e first in*redient
Enter a ne$ value for t,e in*redient line
Field Life Sciences-Pharmaceuticals Chemicals
=n*redient 61 9061
Value 16.1 01
+; Recalculate
Field Life Sciences-Pharmaceuticals Chemicals
ote %ee t,at t,e cost and potenctotals for t,e product are no$increased.
%ee t,at t,e stren*t, total for t,eproduct is no$ increased.
2ote t,at t,is is onl for N$,at-if analsis and does not actuall c,an*e t,e formula.
E?plain t,at t,is screen can be used to s,o$ lot-specific values> based on sampleresults.
0. pdate Formula $it, C,an*ed =n*redient Value
Copyright Oracle Corporation, 2003. All rights reserved.
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+M &ctions @ pdate Formula
+; es
+= Close Form discardin* t,e pendin* c,an*es.
Copyright Oracle Corporation, 2003. All rights reserved.
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Re
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Approve *or&$la Stat$s Change
!ppo'e +o(&la Stat&s C#an$e
90. /o* into Oracle &pplications Portal
Field Life Sciences-Pharmaceuticals Chemicals
sername Process(ops Process(ops
Pass$ord $elcome $elcome
Responsibilit "or#flo$ "or#flo$
99. &pprove t,e formula status c,an*e
+2 &dvanced "or#list
Clic# on 2otification for Formula %tatus C,an*e &pproval
%ee t,e details of t,e formula status c,an*e.
Enter t,e response at t,e bottom of t,e pa*e
Field Life Sciences-Pharmaceuticals Chemicals
%i*nature 3pe Revie$er Revie$er
= ,ave read t,e e-record es es
+; &pprove
Enter t,e electronic si*nature for %andra Copeland
Field Life Sciences-Pharmaceuticals Chemicals
sername PROCE%%(OP% PROCE%%(OP%
Pass$ord $elcome $elcome
+; %i*n
9. /o*out
+L /o*out
Copyright Oracle Corporation, 2003. All rights reserved.
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Create a 9e1 *or&$la +ersion
Ceate a ew +o(&la "esion
95. /o* into Oracle &pplications Portal
Field Life Sciences-Pharmaceuticals Chemicals
sername process process
Pass$ord $elcome $elcome
Responsibilit Formulator Formulator
9:. Auer Formula
+2 Formulas
Field Life Sciences-Pharmaceuticals ChemicalsOr*ani4ation PR1 PR1
+= Find
Field Life Sciences-Pharmaceuticals Chemicals
Formula 961-P=/O3 Ior name of ourc,oice from above@
9161-P=/O3 Ior name of ourc,oice from above@
Version One created!approved above One created!approved above
+; Find
%ee t,at formula status is no$ N&pproved for 8eneral se
9). C,an*e t,e 7uantit for t,e first in*redient line
+3 =n*redients
Clic# on t,e first in*redient line
+; Edit /ine
C,an*e t,e 7uantit for t,e in*redient line
Field Life Sciences-Pharmaceuticals Chemicals
Auantit 16 06
+= %ave
Copyright Oracle Corporation, 2003. All rights reserved.
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& messa*e appears informin* ou t,at a ne$ version $ill be created. &n c,an*es tot,e formula after t,e status ,as been c,an*ed to N&pproved for 8eneral use $ill causea ne$ version to be created $,en Formula Version Control is enabled.
+; OJ +; OJ
2otice t,at t,e version for t,e formula ,as been incremented> and t,e status of t,eformula version is N2e$.
C,an*e or*ani4ation
Field Life Sciences-Pharmaceuticals Chemicals
Or*ani4ation PR1 PR1
+= %ave
+= Close Form
Copyright Oracle Corporation, 2003. All rights reserved.
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+ie1 *or&$las in *or&$lator /or"ench
"iew +o(&las in +o(&lato 1oenc#
9. 2avi*ate to t,e Formulator "or#benc,
+2 Formulator "or#benc,
9. E?plode t,e Formula element in t,e ,ierarc, and scroll do$n to t,e formula created above
+= Formulas
Clic# on t,e +H ne?t to t,e Formulas element to displa t,e list of formulas and dra* t,escroll bar do$n until t,e formula is visible
Field Life Sciences-Pharmaceuticals Chemicals
Formula 961-P=/O3 Ior name of ourc,oice from above@ 9161-P=/O3 Ior name of ourc,oice from above@
Version One Qust created above One Qust created above
2ote t,e status of t,e formula
6. E?plode t,e formulas and t,en e?plode t,e in*redients
+= Clic# on t,e +H ne?t to t,e above Formula
Clic# on t,e above formula element to see t,e Formula Leader %ummar
Clic# on t,e Products element to see t,e Formula Products %ummar
Clic# on t,e +H ne?t to t,e Products
Clic# on t,e product element to see t,e Product /ine Edit %creen
Clic# on t,e =n*redients element to see t,e Formula =n*redients %ummar
Clic# on t,e +H ne?t to t,e =n*redients
Clic# on t,e one of t,e in*redient element to see t,e =n*redient /ine Edit screen
Formulas ,ave properties t,at must be measured. For t,is e?ample> t,epotenc!stren*t, of t,e formula must be measured. 3,e material cost can also bemeasured> if needed.
Close t,e Formulator "or#benc,
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Scale *or&$la+ersion
Scale +o(&la,"esion
1. %cale t,e formula to meet t,e full-scale production 7uantit
+2 Formulas
0. Find t,e Formula
+= Find
Field Life Sciences-Pharmaceuticals Chemicals
Formula!Version 961-P=/O3 Ior name of ourc,oice from above and t,e onet,at is not et approved@
9161-P=/O3 Ior name of ourc,oice from above and t,e onet,at is not et approved @
+; Find
+3 =n*redients
Ma#e a note of t,e current in*redient 7uantities
+3 Products
Clic# in t,e formula ,eader 4one +i.e. Formula field
+M &ctions @ %cale
Enter a percenta*e to scale t,e formula
Field Life Sciences-Pharmaceuticals Chemicals
Factor 966 566
2otice t,at since ou started to scale t,e formula $,ile t,e cursor $as on t,e formula,eader> our onl option is to scale b a percenta*e.
+; OJ
2otice t,at t,e product 7uantit ,as c,an*ed
+3 =n*redients
2otice t,at t,e in*redient 7uantities ,ave c,an*e proportionall
+3 Products
Copyright Oracle Corporation, 2003. All rights reserved.
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Clic# on t,e product +i.e. product field
+M &ctions @ %cale
2otice t,at ou are no$ able to scale b t,e product item 7uantit
Enter a ne$ 7uantit for t,e product line
Field Life Sciences-Pharmaceuticals Chemicals
=tem Auantit C,ec#ed C,ec#ed
2e$ Auantit 1666 5666
+; OJ
2otice t,at t,e product 7uantit ,as a*ain c,an*ed.
+3 =n*redients
2otice t,at t,e in*redient 7uantities ,ave a*ain c,an*ed proportionall
+= %ave
Copyright Oracle Corporation, 2003. All rights reserved.
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Approve *or&$la Stat$s Change
!ppo'e +o(&la Stat&s C#an$e
5. /o* into Oracle &pplications Portal
Field Life Sciences-Pharmaceuticals Chemicals
sername Process(ops Process(ops
Pass$ord $elcome $elcome
Responsibilit "or#flo$ "or#flo$
:. &pprove t,e formula status c,an*e
+2 &dvanced "or#list
Clic# on 2otification for Formula %tatus C,an*e &pproval
%ee t,e details of t,e formula status c,an*e.
Enter t,e response at t,e bottom of t,e pa*e
Field Life Sciences-Pharmaceuticals Chemicals
%i*nature 3pe Revie$er Revie$er
= ,ave read t,e e-record es es
+; &pprove
Enter t,e electronic si*nature for %andra Copeland
Field Life Sciences-Pharmaceuticals Chemicals
sername PROCE%%(OP% PROCE%%(OP%
Pass$ord "elcome "elcome
+; %i*n
). /o*out
+L /o*out
Copyright Oracle Corporation, 2003. All rights reserved.
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Create Ro$ting+ersion to Acco&&odate Scaled *or&$la
Ceate Ro&tin$,"esion to !cco((o%ate Scale% +o(&la
. /o* into Oracle &pplications Portal
Field Life Sciences-Pharmaceuticals Chemicals
sername Process Process
Pass$ord $elcome $elcome
Responsibilit Process En*ineer Process En*ineer
=n t,is e?ample> t,e routin* and its components ,ave alread been ali*ned $it, t,e scaledformula. 3,is $ill allo$ a more streamlined demonstration as ou can simpl s,o$ t,ee?istin* data.
. Create!Modif Routin*
+2 Process Routin*s
Field Life Sciences-Pharmaceuticals Chemicals
Or*ani4ation PR1 PR1
+= Find
Field Life Sciences-Pharmaceuticals Chemicals
Routin* 961-P=/O3 9161-P=/O3
+; Find
%ee t,at t,e status of t,e Routin* is N&pproved for 8eneral se. & ne$ routin* can beentered from scratc, via t,is screen. 3,e same cop functionalit e?ists for t,is screenas for t,e Formula screen> to assist $it, creation of ne$ routin*s. &s $it, formulas>ne$ routin* versions can also be created.
56. Create!Modif Operations
Clic# on t,e first Operation
+; Edit Operation
%ee t,at t,e status of t,e Operation is N&pproved for 8eneral se. & separateOperations screen can also be used to create and maintain operations. Operations canalso be version controlled.
Clic# on t,e &ctivit
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Field Life Sciences-Pharmaceuticals Chemicals
&ctivit R2-3=ME CL-M=
+; Edit &ctivit /ine
&ctivit details can be modified ,ere.
+= Close Edit &ctivities
+; Resources
3,e default tab is 3,rou*,put. %ee t,at t,e t,rou*,put is sufficient for t,e scaledformula.
+3 Cost =nformation +Optional
Revie$ t,e cost classification and analsis information for t,e resources
+3 %c,edulin* =nformation +Optional
Revie$ t,e sc,edulin* information for t,e resources
+; Parameters +Optional
Operation Resource Process Parameters can be entered ,ere
+; Edit Resource /ine
%ee t,e detailed resource information. Plant-specific resource information can bemaintained ,ere +in t,is case t,e plant is t,e o$ner or*ani4ation for t,e routin*' PR1.2ote t,at separate screens are also available to create and maintain resource informationat bot, a *eneric and plant-specific level.
Close all $indo$s and return to navi*ator
Copyright Oracle Corporation, 2003. All rights reserved.
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)sta"lish Ro$ting Step-%ependencies $sing Ro$ting %esigner
Estalis# Ro&tin$ Step-Depen%encies &sin$ Ro&tin$ Desi$ne
51. 2avi*ate to Routin* Desi*ner
=n t,is e?ample> $e $ill s,o$ an e?istin* routin* $it, step-dependencies t,at are alreadestablis,ed in order to streamline t,e demonstration.
+2 Routin* Desi*ner
Routin* Find %creen &ppears
50. Find t,e Routin*
Enter Criteria
Field Life Sciences-Pharmaceuticals Chemicals
Routin* 961-P=/O3 9161-P=/O3
+; Find
+; Edit
59. Revie$ t,e Routin* =nformation
Clic# on t,e +H icon to e?plode t,e routin* element
3,e process instruction s,eet is displaed to t,e ri*,t.
Clic# on t,e +H icon to e?plode t,e second routin* step element
Field Life Sciences-Pharmaceuticals Chemicals
Routin* %tep Element 8R&2/&3=O2 CL-LE&3=28
Clic# on t,e +H icon to e?plode t,e activit element
Field Life Sciences-Pharmaceuticals Chemicals
&ctivit Element R2-3=ME CL-LE&3
Ri*,t clic# on t,e resource and select Properties
Field Life Sciences-Pharmaceuticals Chemicals
Resource ;/E2DER CL-3&2J
Properties for t,e above resource are displaed.
Copyright Oracle Corporation, 2003. All rights reserved.
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/ist of available Operations is displaed. E?plain t,at t,e Routin* Desi*ner is currentlin Dra* mode.
Dra* one of t,e operations to t,e step-dependenc *rap,
Field Life Sciences-Pharmaceuticals Chemicals
Operation For e?ample' 1-P&CJ&8=28 For e?ample' CL-P&CJ&8=28
%tep properties are displaed> allo$in* t,e properties to be defined for a ne$ routin*step.
+; Cancel
+= Connect Mode
E?plain t,at t,e Routin* Desi*ner is no$ in Connect Mode
Clic# and dra* from one step to anot,er step
Field Life Sciences-Pharmaceuticals Chemicals
From %tep PL&RM&C CL-M==28
3o %tep AC CL-AC-0
%tep-dependenc properties are displaed> allo$in* t,e properties to be defined for ane$ step-dependenc.
+; Cancel
%,o$ displa options +Or*-C,ar> =nterleaved> Vertical
Close all $indo$s $it,out savin* t,e c,an*es and return to navi*ator
Copyright Oracle Corporation, 2003. All rights reserved.
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Create 9e1 Recipe fro& Approved *or&$laRo$tingOperation
Ceate ew Recipe fo( !ppo'e% +o(&la,Ro&tin$,Opeation
5:. %$itc, responsibilit
+= %$itc, Responsibilit
Field Life Sciences-Pharmaceuticals Chemicals
Responsibilit Formulator Formulator
&s $it, Formulas and Routin*s> Recipes can be created and maintained via a forms screen.Lo$ever> in t,is e?ample $e $ill s,o$ ,o$ to created a ne$ Recipe via a *rap,ical userinterface called t,e Recipe Desi*ner. Recipes can also be version controlled.
5). Find an e?istin* Recipe
+2 Recipe Desi*ner
Field Life Sciences-Pharmaceuticals Chemicals
Or*ani4ation PR1 PR1
Enter Criteria to Find Recipe
Field Life Sciences-Pharmaceuticals Chemicals
=n*redient 961 9161
E?plain t,e ot,er criteria t,at can be used to find an e?istin* recipe.
+; Find
Field Life Sciences-Pharmaceuticals Chemicals
ote 3,e Recipe for 061 is displaed. Recipes for 9661 and 9660 aredisplaed.
+; Edit
Field Life Sciences-Pharmaceuticals Chemicals
ote 3,e Recipe for 061 is displaedin t,e recipe desi*ner. 2otice t,at961 is an in*redient of t,eformula for t,is recipe
3,e Recipe for 9661 isdisplaed in t,e RecipeDesi*ner. 2otice t,at 9161 is anin*redient of t,e formula fort,is recipe
Close t,e Recipe Desi*ner to return to Find Recipes
Copyright Oracle Corporation, 2003. All rights reserved.
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5. Create a 2e$ Recipe
+; 2e$
Ri*,t Clic# on t,e 2E" Recipe node and select properties
Field Life Sciences-Pharmaceuticals Chemicals
Recipe 961-P=/O3 Ior name of ourc,oice from above@
9161-P=/O3 Ior name of ourc,oice from above@
Version 1 or uni7ue version 0 or uni7ue version
Description Recipe for 961 Pilot Recipe for 9161 Pilot
+3 Formula
Field Life Sciences-Pharmaceuticals Chemicals
Formula 961-P=/O3 Ior name of ourc,oice from above@
9161-P=/O3 Ior name of ourc,oice from above@
Version 0 9
+3 Routin*
Field Life Sciences-Pharmaceuticals Chemicals
Routin* 961-P=/O3 9161-P=/O3
Version 1 1
+; OJ
+= %ave
+= Clic# on t,e +H icon to e?plode t,e recipe and see its details
+3 %tep Dependenc 8rap,
%tep dependenc *rap, is displaed. %ee t,at Routin* Desi*ner is also available from$it,in Recipe Desi*ner.
5. Establis, %tep-item Dependencies
Clic# on t,e +H icon to e?plode t,e first operation node
+3 =n*redients
+2 Vie$ nassi*ned =tems
Dra* one of t,e in*redients to t,e operation node to create an item step dependenc
Copyright Oracle Corporation, 2003. All rights reserved.
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+= %ave
:6. Re7uest C,an*e of %tatus for Recipe
+M &ctions-@ C,an*e %tatus
+; es to c,an*es pendin* note
%elect ne$ status
Field Life Sciences-Pharmaceuticals Chemicals
C,an*e %tatus 3o &pproved for 8eneral se &pproved for 8eneral se
+; OJ
Electronic %i*natures is displaed s,o$in* t,e approvals needed.
+; %ubmit
+; es and close Electronic %i*natures
+; OJ
%tatus of recipe $ill no$ be NRe7uest &pproval for 8eneral se
Close Recipe Desi*ner
:1. /o*out
E?it Oracle &pplications
+L /o*out
Copyright Oracle Corporation, 2003. All rights reserved.
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Approve Recipe Stat$s Change
!ppo'e Recipe Stat&s C#an$e
:0. /o* into Oracle &pplications Portal
Field Life Sciences-Pharmaceuticals Chemicals
sername Process(ops Process(ops
Pass$ord $elcome $elcome
Responsibilit "or#flo$ "or#flo$
:9. &pprove t,e recipe status c,an*e
+2 &dvanced "or#list
Clic# on 2otification for Recipe %tatus C,an*e &pproval
%ee t,e details of t,e recipe status c,an*e.
Enter t,e response at t,e bottom of t,e pa*e
Field Life Sciences-Pharmaceuticals Chemicals
%i*nature 3pe Revie$er Revie$er
= ,ave read t,e e-record es es
+; &pprove
Enter t,e electronic si*nature for %andra Copeland
Field Life Sciences-Pharmaceuticals Chemicals
sername PROCE%%(OP% PROCE%%(OP%
Pass$ord "elcome "elcome
+; %i*n
:. /o*out
+L /o*out
Copyright Oracle Corporation, 2003. All rights reserved.
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Create a Recipe +alidity R$le
Ceate a Recipe "ali%it) R&le
:5. /o* into Oracle &pplications Portal
Field Life Sciences-Pharmaceuticals Chemicals
sername Process Process
Pass$ord $elcome $elcome
Responsibilit Formulator Formulator
::. 2avi*ate to Recipe %creen and Find Recipe
+2 Recipes
Field Life Sciences-Pharmaceuticals ChemicalsOr*ani4ation PR1 PR1
+= Find
Field Life Sciences-Pharmaceuticals Chemicals
Recipe 961-P=/O3 Ior name of ourc,oice from above@
9161-P=/O3 Ior name of ourc,oice from above@
Version 1 IOne approved above@ 0 or IOne approved above@
+; Find
Recipe is displaed. 2otice t,at t,e status is no$ N&pproved for 8eneral se.
:). Create a Recipe Validit Rule
+; Validit Rules
Enter Or*ani4ation
Field Life Sciences-Pharmaceuticals Chemicals
Or*ani4ation PR1 PR1
+= %ave
:. Re7uest C,an*e of %tatus for Validit Rule
+M &ctions-@ C,an*e %tatus
Copyright Oracle Corporation, 2003. All rights reserved.
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%elect ne$ status
Field Life Sciences-Pharmaceuticals Chemicals
C,an*e %tatus 3o &pproved for 8eneral se &pproved for 8eneral se
+; OJ
Electronic %i*natures is displaed s,o$in* t,e approvals needed.
+; %ubmit
+; es and close Electronic %i*natures
+; OJ
%tatus of validit is no$ NRe7uest &pproval for 8eneral se
Close Forms
:. /o*out
E?it Oracle &pplications
+L /o*out
Copyright Oracle Corporation, 2003. All rights reserved.
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Approve Recipe +alidity R$le Stat$s Change
!ppo'e Recipe "ali%it) R&le Stat&s C#an$e
)6. /o* into Oracle &pplications Portal
Field Life Sciences-Pharmaceuticals Chemicals
sername Process(ops Process(ops
Pass$ord $elcome $elcome
Responsibilit Formulator Formulator
)1. &pprove t,e recipe validit rule status c,an*e
+2 "or#flo$ @ &dvanced "or#list
Clic# on 2otification for Recipe Validit %tatus C,an*e &pproval
%ee t,e details of t,e recipe status c,an*e.
Enter t,e response at t,e bottom of t,e pa*e
Field Life Sciences-Pharmaceuticals Chemicals
%i*nature 3pe Revie$er Revie$er
= ,ave read t,e e-record es es
+; &pprove
Enter t,e electronic si*nature for %andra Copeland
Field Life Sciences-Pharmaceuticals Chemicals
sername PROCE%%(OP% PROCE%%(OP%
Pass$ord "elcome "elcome
+; %i*n
+L Lome
)0. Revie$ t,e recipe and validit rule to see t,at t,e status ,as c,an*ed.
+2 Recipes
Field Life Sciences-Pharmaceuticals Chemicals
Or*ani4ation PR1 PR1
Copyright Oracle Corporation, 2003. All rights reserved.
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+= Find
Field Life Sciences-Pharmaceuticals Chemicals
Recipe 961-P=/O3 Ior name of ourc,oice from above@
9161-P=/O3 Ior name of ourc,oice from above@
Version 1 IOne approved above@ 0 or IOne approved above@
+; Find
+; Validit Rules
%ee t,at t,e validit rule is no$ N&pproved for 8eneral se
En% of acti'it).
Demo Support
Please see ,ttp'!!ads$eb.oracleads.com @ +M %upport @ Procedures> for current informationre*ardin* demonstration support.
Copyright Oracle Corporation, 2003. All rights reserved.
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*lo1chart
Start
+nable 'ormula
,ersion Control
Log into OracleApplications ortal 6'7>$ery Organi:ationara&eters for R' 627)na"le *or&$la+ersion Control forOrgani:ation R' 637>$ery Organi:ationara&eters for La"Organi:ation 6(7)na"le *or&$la+ersion Control for La"Organi:ation 6,7
,eri$.+nable
Pro$ile Options $or'ormula.Recipe
Wor$lo"s / +R+S
%pproval $or user0
Process1Ops
S1itch Responsi"ility67
,eri$.+nable
Pro$ile Options $or
'ormula.Recipe
Wor$lo"s / +R+S%pproval $or user0
Process1Ops
>$ery rofile Optionsfor *or&$laRecipe/orflo1s ? )R)SApproval 647+erify)na"le rofileOptions for *or&$laRecipe /orflo1s ?)R)S Approval 657
Create a Pilot
Routin ('or
Chemicals Demo
Onl)
*ind an e@isting ro$tingto copy 687Copy ro$ting to create ane1 one 6'07Approve Ro$ting 6''7Logo$t 6'27
,eri$ De$ault *ab
Pro$ile
Log into Oracle
Applications ortal 6'37+erify rofile 6'(7
,eri$.+nable
Pro$ile Options $or
'ormula.Recipe
Wor$lo"s / +R+S
%pproval $or user0
Process
S1itch Responsi"ility6',7>$ery rofile Optionsfor *or&$laRecipe/orflo1s ? )R)SApproval 6'7
+erify)na"le rofileOptions for *or&$laRecipe /orflo1s ?)R)S Approval 6'47
A
Copyright Oracle Corporation, 2003. All rights reserved.
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re %e&oSteps co&pleteB
Start Demo $rom
ads"eb
67 httpads1e".oracleads.co&6'5767 A%S La$nchpad6'87
Create a !e"
'ormula
Log into OracleApplications ortal 6207*ind an e@isting for&$la
to copy 62'7Copy for&$la to createa ne1 one 6227
Setup 2echnical
Data
Set$p a !echnicalara&eter 6237Set$p !echnicalara&eter Se$ery *or&$la 637
Change
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%pprove Recipe
Status Chane
Log into OracleApplications ortal 627Approve recipe stat$schange 637Logo$t 6(7
Create a Recipe
,alidit Rule
Log into OracleApplications ortal 6,79avigate to RecipeScreen ? *ind Recipe67Create a Recipe+alidity R$le 647Re