Project Genesys !

are ouse "ault Report #ate last modified$ %%&%'&())'

Reports - Functional Specification Controlled Substance Samples Awaiting QC Testing in t e "ersion$ % R##(%%

November 16, 2006 Version 1

Report - Functional Specification RDD211 Controlled Substance Samples Awaiting QC Testing in the arehouse !ault Report "ro#ect $enes%s

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Reports - Functional Specification Controlled Substance Samples Awaiting QC Testing in t e "ersion$ % R##(%%

Approval
Completion of t e following signature bloc*s signifies t e appro+er as read, understands, and agrees wit t e content of t is document

Name Rafael Cabrera

Authority Senior -anager Computer "alidation Process 3usiness /wner 4T5S Quality Assurance Representati+e Cep alon Team 6ead

Signature

Date 1mm&dd&yy2

Document History
Version
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Date
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Author
-arilyn .e+ille& "asud a Goteti /riginal +ersion0

Comments

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Reports - Functional Specification Controlled Substance Samples Awaiting QC Testing in t e "ersion$ % R##(%%

Table of Contents
1.0 FUNCTIONAL !TAIL".....................................................................................................................# 2.0 A ITIONAL !TAIL"......................................................................................................................6

$.0 !"I%N !TAIL".................................................................................................................................& 3.1 APPLICATI ! "#P "T$........................................................................................................................% 3.2 &' "#P "T A$$#$$(#!T....................................................................................................................) 3.3 &' "#P "T$......................................................................................................................................10

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Reports - Functional Specification Controlled Substance Samples Awaiting QC Testing in t e "ersion$ % R##(%%

1.0

!NCT"#NA$ D%TA"$S

The purpose of this section is to clearly communicate the functional details of the business re*uirement to allo+ the system de,eloper to build accurate desi-ns and solutions to meet the business need. All business rules associated +ith the business re*uirement should be detailed in this document. Care should also be ta.en to accurately and fully document all report layout re*uirements and calculation rules.

FUNCTIONAL '!(UI'!)!NT" !FINITION

.eed to a+e access to Controlled Substance Samples Awaiting QC Testing in t e !are ouse "ault Report data t at will enable QC to sign-off on controlled substances mo+e from t e +ault to t e QC 6aboratory0 4ntroduction&3ac*ground&3usiness 3enefits$ T is report will pro+ide a tool for QC to sign-off on controlled substances mo+e from t e +ault to t e QC 6aboratory0

Scope&#etailed #escription$ Samples are pulled for QC testing, from t e manufacturing +ault0 A report needs to be automatically generated t at reports t e batc number and production stage of t e materials t at are pulled for sampling and transferred to t e QC 6aboratory0 Areas impacted$ -anufacturing and Quality0

#ependencies$ Include predecessor and successor processes. Process /rders must a+e been released and specific p ases recorded t at trigger t at Controlled Substance materials a+e been placed in t e -anufacturing "ault and are ready for testing0

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Reports - Functional Specification Controlled Substance Samples Awaiting QC Testing in t e "ersion$ % R##(%%

3usiness Process #etail$ Define all Business Processes that will use this development. Identify specific Business Process and how they are impacted. Currently S6C records +arious operations 1P ases2 for a process order0 Specific p ases indicate w et er or not t e process order product contains controlled substance material and needs to be test by t e QC laboratory personnel0

Process rder is released.

"ecord labor4Phases.

no

3o not print on "eport.

3oes labor4phase recorded indicate that product needs to be 5C tested6

yes

Print &atch !umber and Phase 1$ta-e2 on "eport.

#nd.

3usiness Rules&Assumptions$

Capacity &lanning %stimates Proprietary

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Project Genesys !are ouse "ault Report #ate last modified$ %%&%'&())' Pea* "olume A+erage "olume Fre7uency Record Si9e Processing time 1per record2

Reports - Functional Specification Controlled Substance Samples Awaiting QC Testing in t e "ersion$ % R##(%%

/n-demand and eac morning print report and email to selected users at 8$))am -#T0

'.0
:nit Test Suggestions$ Security& Aut ori9ations ;rror andling Arc i+ing 3ac* :p Plan$

ADD"T"#NA$ D%TA"$S

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Reports - Functional Specification Controlled Substance Samples Awaiting QC Testing in t e "ersion$ % R##(%%

(.0
(.1 Application *eports

D%S")N D%TA"$S

'!PO'T
-ode of ;<ecution Special Printing&-edia Re7uirements #istribution&"olume Paper si9e Page /rientation 6ogo Classification /n #emand and Automatically distributed +ia email at 8$))am to selected list of users0

Standard Portrait

*eport Selection Criteria

See %+cel Sprea,sheet -Assigne, No.Title/0 1or2sheet -*eport Selection Criteria/

*eport 3apping 3atri+

.ote any calculations&con+ersions or special andling0 See %+cel Sprea,sheet -Assigne, No.Title/0 1or2sheet -*eport 3apping 3atri+/

G$=FS R##%(% ;nd of 6ot Report +%0%0doc0<ls

*eport $ayout
#escribe t e detailed information and t e processing logic for t e Report layout0 4nclude >eader&Footer details and indicate page brea* wit respect to report fields0 "nsert *eport $ayout sample attachment if applicable Report ;<ample$

Adobe Acrobat ?0) #ocument

Proprietary
This document is proprietary and intended for use by Cephalon only; all other uses are strictly Prohibited. % of 10

Project Genesys !are ouse "ault Report #ate last modified$ %%&%'&())'

Reports - Functional Specification Controlled Substance Samples Awaiting QC Testing in t e "ersion$ % R##(%%

(.' 41 *eport Assessment 'eport 'e*evan+e to Cep,a*on -oa*s an. o/t+ome meas/res
89 "eport pro,ides information directly related to or that can help impro,e decisions related to -oals or associated measures If none of the abo,e is chosen additional business :ustification is needed before proceedin- +ith de,elopment of report in the business benefits section

Per0e+t Or.er !00i+ien+y C/stomer "atis0a+tion Comp*ian+e Cost )ana-ement 1ey Pro+ess )eas/res None o0 t,e Above

'eport Content Consi.erations

Place 8 in the appropriate column

In0ormation %ran/*arity Transactional 13etail only2 A--re-ate 1$ummary2 &oth Fre2/en+y o0 in0ormation 3 'ee.ly 'ee.ly or more 4istory avai*ab*e in reportin"eal Time ;istorical <ie+ "o/r+e o0 in0ormation $elf=contained 1$AP Application e.-. A"2 Cross=>unctional 1(ultiple $AP Applications or outside $AP2

5/siness Criti+a*ity an. Priority

Opport/nity Cost 6estimate. impa+t o0 not ,avin- t,e report7 Lo+ Proprietary
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Project Genesys !are ouse "ault Report #ate last modified$ %%&%'&())'

Reports - Functional Specification Controlled Substance Samples Awaiting QC Testing in t e "ersion$ % R##(%%

(edium ;i-h Time yo/ +an )ana-e 8it,o/t report 9 'ee. (onth ? 1 (onth N/mber o0 meas/res in report 1=2 3=/ 0 or more

Comp*e:ity o0 eve*opment
Avai*abi*ity o0 ata 3ata e@ists in the form needed 1"432 3ata e@ists in "43A but re*uires manipulation before can be used for reportin3ata does not e@ist +ithin "43 A++essibi*ity o0 .ata 3ata is a,ailable on=line to potential users 3ata is onlineA but not for all users 1i.e. In databaseA but no con,enient +ay to -et information2 3ata is in "43 but not a,ailable on=line

B (ost &' reports +ill re*uire 1 or more months of production data in $AP "43 before data can be loaded into &' for reportin- purposes

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Reports - Functional Specification Controlled Substance Samples Awaiting QC Testing in t e "ersion$ % R##(%%

(.( 41 *eports 41 *%&#*TS

#istribution&"olume Special Printing&-edia Re7uirements Sort Criteria -ode of ;<ecution Classification Fre7uency of update Periods reported Reporting #imensions Reporting against Target +alue @ears of istory needed State how many people / groups / copies and approximate volume size. Only if applica le! e.g. paper size! page orientation if re"uired for a B# report See spreadsheet On Demand! Batch e.g. $onfidential %&alid classification levels' daily! wee(ly! monthly! "uarterly daily! wee(ly! monthly! "uarterly ).g. franchise! order type! product family Do you want to report against a *arget value +etention period of underlying data

User Comm/nity
Role Function of User Department Estimated # of Users Special Security needs

*eport Selection Criteria

See %+cel Sprea,sheet -41.Assigne, No.Title/0 1or2sheet -41 Selection an, Drill,o5n/

*eport Data 3apping

See %+cel Sprea,sheet -41.Assigne, No.Title/0 1or2sheet -41 *eport 3apping/

ormula
See %+cel Sprea,sheet -41.Assigne, No.Title/0 1or2sheet -41 ormula/

A3!BAs signed noBTitle0<lsA

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