opm product development concept to release r12

8/9/2019 OPM Product Development Concept to Release r12

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OPM Product Development -Concept to Release

Demo Script (Internal)

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Releaseage i


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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..................................................................................................................................................................


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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


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)


Life Sciences - Concept to Releaseage (


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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


Or*ani4ation PR1 PR1

+; Find

9. Enable Formula Version Control for Or*ani4ation PR1

+3 Formula


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



Life Sciences - Concept to Releaseage


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Or*ani4ation /&1 /&0

+; Find

5. Enable Formula Version Control for /ab Or*ani4ation

+3 Formula


Version Control es es

+= %ave> if c,an*e made.

+= Close Form


Life Sciences - Concept to Releaseage


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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


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


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


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




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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


Life Sciences - Concept to Releaseage '0


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+erify %efa$lt La" rofile

"eif) Defa&lt La *ofile



sername process process

Pass$ord $elcome $elcome

Responsibilit %stem &dministrator %stem &dministrator

1. Verif Profile

+2 Profile @ %stem

Enter searc, criteria


ser PROCE%% PROCE%%

Profile 8MD' Default /ab Or*ani4ation 8MD' Default /abOr*ani4ation

+; Find

%elect lab or*ani4ation


ser Value /&1 /&0

+; OJ

+= Close Form


Life Sciences - Concept to Releaseage ''


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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


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


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


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




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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


Life Sciences - Concept to Releaseage '(


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Create a 9e1 *or&$la

Ceate a ew +o(&la






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



+= Find


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.


Life Sciences - Concept to Releaseage '


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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


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


=n*redient 61 9061

C,an*e t,e 7uantit for t,e in*redient line


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


Life Sciences - Concept to Releaseage '


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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


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



+; 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



+; Find




21/48

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




22/48

Analy:e *or&$la ;sing Si&$lator

!nal)>e +o(&la Usin$ Si(&lato

0:. 2avi*ate to %imulator

+2 %imulator

+= Find


Formula!Version 961-P=/O3 Ior name of ourc,oice from above@

9161-P=/O3 Ior name of ourc,oice from above@

+; Find


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


=n*redient 61 9061

Value 16.1 01

+; Recalculate


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




23/48

+M &ctions @ pdate Formula

+; es

+= Close Form discardin* t,e pendin* c,an*es.


Life Sciences - Concept to Releaseage 2'


24/48

Re


25/48

Approve *or&$la Stat$s Change

!ppo'e +o(&la Stat&s C#an$e





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


%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


sername PROCE%%(OP% PROCE%%(OP%


+; %i*n

9. /o*out

+L /o*out




26/48

Create a 9e1 *or&$la +ersion

Ceate a ew +o(&la "esion






9:. Auer Formula

+2 Formulas

Field Life Sciences-Pharmaceuticals ChemicalsOr*ani4ation PR1 PR1

+= Find


Formula 961-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


Auantit 16 06

+= %ave


Life Sciences - Concept to Releaseage 2(


27/48

& 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



+= %ave

+= Close Form




28/48

+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


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,




29/48

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


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


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




30/48

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


=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




31/48

Re


32/48

Approve *or&$la Stat$s Change

!ppo'e +o(&la Stat&s C#an$e






:. &pprove t,e formula status c,an*e


Clic# on 2otification for Formula %tatus C,an*e &pproval

%ee t,e details of t,e formula status c,an*e.





+; &pprove





+; %i*n

). /o*out

+L /o*out




33/48

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


sername Process Process


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



+= Find


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


Life Sciences - Concept to Releaseage 3'


34/48


&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




35/48

)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


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


Routin* %tep Element 8R&2/&3=O2 CL-LE&3=28

Clic# on t,e +H icon to e?plode t,e activit element


&ctivit Element R2-3=ME CL-LE&3

Ri*,t clic# on t,e resource and select Properties


Resource ;/E2DER CL-3&2J

Properties for t,e above resource are displaed.




36/48


37/48

/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,


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


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




38/48

Create 9e1 Recipe fro& Approved *or&$laRo$tingOperation

Ceate ew Recipe fo( !ppo'e% +o(&la,Ro&tin$,Opeation

5:. %$itc, responsibilit

+= %$itc, Responsibilit



&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



Enter Criteria to Find Recipe


=n*redient 961 9161

E?plain t,e ot,er criteria t,at can be used to find an e?istin* recipe.

+; Find


ote 3,e Recipe for 061 is displaed. Recipes for 9661 and 9660 aredisplaed.

+; Edit


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




39/48

5. Create a 2e$ Recipe

+; 2e$

Ri*,t Clic# on t,e 2E" Recipe node and select properties


Recipe 961-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


Formula 961-P=/O3 Ior name of ourc,oice from above@


Version 0 9

+3 Routin*


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




40/48

+= %ave

:6. Re7uest C,an*e of %tatus for Recipe


+; es to c,an*es pendin* note

%elect ne$ status


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


+L /o*out




41/48

Approve Recipe Stat$s Change

!ppo'e Recipe Stat&s C#an$e

:0. /o* into Oracle &pplications Portal





:9. &pprove t,e recipe status c,an*e


Clic# on 2otification for Recipe %tatus C,an*e &pproval

%ee t,e details of t,e recipe status c,an*e.





+; &pprove





+; %i*n

:. /o*out

+L /o*out




42/48

Create a Recipe +alidity R$le

Ceate a Recipe "ali%it) R&le

:5. /o* into Oracle &pplications Portal


sername Process Process



::. 2avi*ate to Recipe %creen and Find Recipe

+2 Recipes

Field Life Sciences-Pharmaceuticals ChemicalsOr*ani4ation PR1 PR1

+= Find




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



+= %ave

:. Re7uest C,an*e of %tatus for Validit Rule



Life Sciences - Concept to Releaseage (0


43/48

%elect ne$ status


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


+L /o*out


Life Sciences - Concept to Releaseage ('


44/48

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





)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.





+; &pprove





+; %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






45/48

+= Find




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.




46/48

*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


Life Sciences - Concept to Releaseage ((


47/48

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


48/48

%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