Data Directory * GxP: guideline for ‘Good working Practice’ pertaining to various branches of the pharmaceutical industry. *CSQA: Computerised System Quality Assurance Field Name Data Type Description Vendor CHAR (10) Vendor number ID Audit Status CHAR (15) Closed/Not in Scope/In Process/ Pending/Completed In USA or OUS CHAR (3) Activity take place in United State or outside of United State Location CHAR(20) In U.S: City, State Outside U.S: City, Country Vendor Primary Contact VARCHAR Vendor Primary Contact Information Vendor Secondary Contact VARCHAR Vendor Secondary Contact Information VRTX Business Sponsor CHAR Vertex Business Sponsor initial Service Audited CHAR Vertex Service GxP Area CHAR (3) GCP: Good Clinical Practice audits. GLP: Good Laboratory Practice audit. GMP: Good Manufacturing Practice, audits of manufacturing sites. GDP: Good Distribution Practice, audits of distribution and logistic partners. GVP: Good Vigilance Practice, Audits of pharmacovigilance service providers Audit Type VARCHAR (40) Qualification/Requalification/Requalification with Questionnaire/Questionnaire Audit Method VARCHAR (30) None/On-site/Questionnaire in 2016/Questionnaire/Remote/None/TBD, on-site * CSQA did not participate Proposed Quarter CHAR(6) Quarter 1/Quarter 2/Quarter 3/Quarter 4/Quarter 3 and 4 VRTX QA coordinator CHAR(3) QA coordinator initial GxP Auditor CHAR(5) GxP auditor initial CSQA Auditor CHAR (5) CSQA auditor initial TrackWise (TW) Report Number NUMBER (5) TrackWise system generated reports number Date of Intake Date Date Questionnaire sent Date Questionnaire sent date Date Questionnaire received Date Questionnaire received date Date on Site Scheduled Date On-site audit date Audit Start Date Date Audit process start date Audit End Date Date Audit process complete date Date Final Report Due Date Audit final report due date Date of Completion Date Audit final report actual complete date Date Observations sent to Vendor Date Observations form sent to vendor to review Observation Responses Due Date Require observation response due date Date Observation Responses Received from Vendor Date Actual date observation responses received from vendor Observations CHAR (10) Major/Minor Observations in TW VARCHAR(30) Observations outcome in TrackWise Observation Due date Date Observation required due date Observation Assigned to CHAR(2) Observation assigned auditor initial Closed Date (Observation closed in Trackwise) Date Observation completed date Sheet1VendorData Integrity Report StatusAudit StatusIn USA or OUSLocationServices AuditedGxP AreaAudit TypeAudit MethodProposed QuarterVRTX QA CoordinatorCSQA AuditorTW Report NumberDate of IntakeDate Q sentDate Q RcvdDate On Site ScheduledAudit Start Date Audit End DateDate Final Report DueDate of audit pre-scope meetingDate of audit debrief meetingDate of CompletionNotesCS Vendor 1(unknown)CompletedOUSLeeds, UKHosted artwork management system,GI.

1. Data Directory
* GxP: guideline for ‘Good working Practice’ pertaining to
various branches of the pharmaceutical industry.
*CSQA: Computerised System Quality Assurance
Field Name
Data Type
Description
Vendor
CHAR (10)
Vendor number ID
Audit Status
CHAR (15)
Closed/Not in Scope/In Process/ Pending/Completed
In USA or OUS
CHAR (3)
Activity take place in United State or outside of United State
Location
CHAR(20)
In U.S: City, State
Outside U.S: City, Country
Vendor Primary Contact
VARCHAR
Vendor Primary Contact Information
Vendor Secondary Contact
VARCHAR
Vendor Secondary Contact Information
VRTX Business Sponsor
CHAR
Vertex Business Sponsor initial
Service Audited
CHAR
Vertex Service
GxP Area

2. CHAR (3)
GCP: Good Clinical Practice audits.
GLP: Good Laboratory Practice audit.
GMP: Good Manufacturing Practice, audits of manufacturing
sites.
GDP: Good Distribution Practice, audits of distribution and
logistic partners.
GVP: Good Vigilance Practice, Audits of pharmacovigilance
service providers
Audit Type
VARCHAR (40)
Qualification/Requalification/Requalification with
Questionnaire/Questionnaire
Audit Method
VARCHAR (30)
None/On-site/Questionnaire in
2016/Questionnaire/Remote/None/TBD, on-site * CSQA did not
participate
Proposed Quarter
CHAR(6)
Quarter 1/Quarter 2/Quarter 3/Quarter 4/Quarter 3 and 4
VRTX QA coordinator
CHAR(3)
QA coordinator initial
GxP Auditor
CHAR(5)
GxP auditor initial
CSQA Auditor
CHAR (5)
CSQA auditor initial
TrackWise (TW) Report Number
NUMBER (5)
TrackWise system generated reports number
Date of Intake
Date

3. Date Questionnaire sent
Date
Questionnaire sent date
Date Questionnaire received
Date
Questionnaire received date
Date on Site Scheduled
Date
On-site audit date
Audit Start Date
Date
Audit process start date
Audit End Date
Date
Audit process complete date
Date Final Report Due
Date
Audit final report due date
Date of Completion
Date
Audit final report actual complete date
Date Observations sent to Vendor
Date
Observations form sent to vendor to review
Observation Responses Due
Date
Require observation response due date
Date Observation Responses Received from Vendor
Date
Actual date observation responses received from vendor
Observations
CHAR (10)
Major/Minor
Observations in TW
VARCHAR(30)
Observations outcome in TrackWise

4. Observation Due date
Date
Observation required due date
Observation Assigned to
CHAR(2)
Observation assigned auditor initial
Closed Date (Observation closed in Trackwise)
Date
Observation completed date
Sheet1VendorData Integrity
Report StatusAudit StatusIn USA or OUSLocationServices
AuditedGxP
AreaAudit
TypeAudit
MethodProposed
QuarterVRTX QA CoordinatorCSQA AuditorTW Report
NumberDate of IntakeDate Q sentDate Q RcvdDate On Site
ScheduledAudit Start Date
Audit End DateDate Final
Report DueDate of audit pre-scope meetingDate of audit debrief
meetingDate of
CompletionNotesCS Vendor 1(unknown)CompletedOUSLeeds,
UKHosted artwork management system,GISOn
SiteQualificationQ1AlI

5. KaraaJA224011/19/17(unknown)(unknown)1/30/173/1/173/2/17
4/1/17(unknown)3/2/174/10/17CS Vendor
2(unknown)CompletedUSACincinnati, OHComputerized
SystemsGMPOn SiteRequalificationQ1WSWS/
CL225862/22/17(unknown)(unknown)2/22/173/29/173/30/174/2
9/17(unknown)4/7/174/28/17CS Vendor
3(unknown)CompletedOUSWommelgem, BelgiumGISOn
SiteRequalificationQ1WSWS227602/22/17(unknown)(unknown)
2/22/173/7/173/8/174/7/17(unknown)4/6/174/7/17CS Vendor
7(unknown)ClosedUSAPrinceton, NJManged Service provider
for systemGISOn SiteQualificationQ1AlI
KaraaMD238493/8/17(unknown)(unknown)5/31/177/25/177/26/
178/25/177/11/178/1/1710/4/17CS Vendor
9(unknown)CompletedUSAPleasanton, CADMSGISOn
SiteRequalificationQ3Ali
KaraaAA238044/3/17(unknown)(unknown)6/20/178/22/178/23/1
79/22/177/10/178/28/179/27/17CS Vendor
10(unknown)CompletedUSAGreenville, NCQuality Systems
Assessment; Software Development Life Cycle Process;
Software Design, testing and implementation; change control
and configuration management; 21CFR Part 11 capabilities;
Problem reporting; Disaster recovery; Supporting SOPs and
Test EvidenceGISOn SiteRequalificationQ3Ali
KaraaAA235854/3/17(unknown)(unknown)5/24/177/18/177/19/1
78/18/176/29/177/24/178/18/17CS Vendor
15(unknown)CompletedOUSRichmond, BC CanadaGMP
Temperature and Humidity Monitoring SystemGISOn
SiteRequalificationQ3Ali
KaraaCL238124/3/17(unknown)(unknown)6/15/178/14/178/15/1
79/14/177/25/178/22/179/27/17CS Vendor
17(unknown)CompletedUSAPrinceton, NJQuality Systems
Assessment; System Life Cycle Process; Software Design and
Testing; Change Control; User Acceptance Process; Part 11
Assesment; Security, Network and Disatser Recovery Controls;
A selection of related SOPs and validation documentation (filed
in )GISOn SiteRequalificationQ3Ali

6. KaraaMD235364/3/17(unknown)(unknown)5/26/177/13/177/13/
178/12/176/30/177/18/178/11/17CS Vendor
18(unknown)ClosedUSACary, NCSDLC ( Software
Development Life Cycle) and SLC (System Life Cycle)
processes.GISQuestionnaireRequalificationQ3Ali
KaraaMD235354/3/176/16/176/30/17(unknown)(unknown)(unkn
own)7/30/17(unknown)(unknown)8/10/17CS Vendor
19(unknown)ClosedUSABurlington, MATape Vaulting
ServicesGISOn SiteRequalificationQ3Ali
KaraaBM234264/3/17(unknown)(unknown)5/24/177/11/177/11/
178/10/176/27/177/14/178/10/17CS Vendor
21(unknown)CompletedUSAPalo Alto, CASoftware Service
ProviderGISQuestionnaireRequalificationQ3AlI
KaraaCL239957/11/178/7/178/29/17(unknown)(unknown)(unkn
own)9/28/17(unknown)(unknown)9/28/17CS Vendor
23(unknown)CompletedUSABoston, MAData Review
ProcessGCPOn SiteInternalQ2AlI KaraaJR7/13/17
2017 GxP
AuditsVendorAudit.StatusIn.USA.or.OUSLocationServices.Aud
itedGxP.AreaAudit.TypeAudit.MethodProposed.QuarterVRTX.
QA.CoordinatorGxP.AuditorCSQA.AuditorTW.Report.NumberD
ate.of.IntakeDate.Q.sentDate.Q.RcvdDate.On.Site.ScheduledAu
dit.Start.DateAudit.End.DateDate.Final..Report.DueDate.of..Co
mpletionCompletedNotesVendor1Not In ScopeOUSBonn,
Germanyconsulting/cenral budget negotiations for sites lcoated
in Germany, Vendor (select studies), and website posting (select
studies)GCPQualificationNoneQ2JMD(Unknown)(Unknown)(U
nknown)1/5/17(Unknown)(Unknown)(Unknown)(Unknown)(Un
known)(Unknown)(Unknown)(Unknown)Vendor2ClosedUSAPri
nceton, NJCROGCPQualificationOn
SiteQ1JMDMRDF225521/5/17(Unknown)(Unknown)(Unknown)
2/14/172/16/173/15/173/16/17Delayed
Vendor3PendingOUSMunich,
Germany(Unknown)GCPQualificationTBDQ3JMD(Unknown)(U
nknown)(Unknown)1/5/17(Unknown)(Unknown)(Unknown)(Un

7. known)(Unknown)(Unknown)(Unknown)(Unknown)Vendor4Co
mpletedUSAIndianapolis, INLife cycle of data during the
sample processing stages; Study start up; Translation of
protocols into lab tests and how they are performed,
documented, and managed; Global processes and harmonization
between other Vendor sites; Linkage of systems at other Vendor
labs and usage of a centralized system for data; Robust process
in place for third party labs and oversight of transferring
samples at different locations; Tech transfer process; Sample
managementGCPQualificationOn
SiteQ1JMDMRAA(Unknown)1/5/17(Unknown)(Unknown)6/5/1
77/12/177/13/178/12/178/11/17On-
timeVendor5ClosedOUSHeidelberg,
Germany(Unknown)GCPQualificationOn
SiteQ1JMDPKDF225011/13/17(Unknown)(Unknown)(Unknown
)2/7/172/8/173/10/173/10/17On-
timeVendor6ClosedOUSOntaria, Canada Registry
DatabaseGCPQualificationQuestionnaireQ1JMDJOLG226201/1
3/171/19/172/1/17(Unknown)(Unknown)(Unknown)3/3/173/3/17
On-timeVendor7ClosedOUSOakville,
Canada(Unknown)GCPQualificationQuestionnaireQ1JMDJOLG
223721/13/171/19/172/2/17(Unknown)(Unknown)(Unknown)3/3
/173/3/17On-timeVendor8ClosedUSADurham,
NC(Unknown)GCPRequalificationOn
SiteQ1JMDKBMD231341/13/17(Unknown)(Unknown)1/13/172/
20/172/23/173/25/173/24/17On-
timeVendor9ClosedUSAMattawan, MIGeneral Toxicology
Genetic Toxicology
Carcinogenicity
Safety Pharmacology
Analytical
Bioanalytical
ToxicokineticsGLPRequalificationOn
SiteQ2MMRDAK231351/13/17(Unknown)(Unknown)3/17/174/2
5/174/27/175/27/175/19/17On-
timeVendor10ClosedUSARockville, MDGenetic Toxicology

8. Mammalian Toxicology
Clinical Pathology
Safety Pharmacology
Histopathology
Bioanalytical
Analytical
ToxicokineticsGLPRequalificationOn
SiteQ1MMRDDF226481/13/17(Unknown)(Unknown)3/8/173/21
/173/23/174/22/174/21/17On-timeVendor11Not In
ScopeUSAAshland, OHGeneral Toxicology
Genetic Toxicology
Carcinogenicity
Safety Pharmacology
Analytical
BioanalyticalGLPRequalificationNoneQ1MM(Unknown)TBD(U
nknown)1/13/17(Unknown)(Unknown)(Unknown)(Unknown)(U
nknown)(Unknown)(Unknown)(Unknown)Vendor12ClosedUSA
Emeryville,
CA(Unknown)GVPQualificationQuestionnaireQ1DL(Unknown)
LG223791/25/171/26/173/23/17(Unknown)(Unknown)(Unknow
n)4/22/174/10/17On-timeVendor13ClosedOUSPrague, Czech
Republic(Unknown)GVPQualificationQuestionnaireQ1DL(Unkn
own)LG221921/25/171/26/173/1/17(Unknown)(Unknown)(Unkn
own)4/1/174/4/17Delayed Vendor14ClosedOUSPetach Tikva,
Israel(Unknown)GVPQualificationQuestionnaireQ1DL(Unknow
n)LG222031/25/171/27/172/28/17(Unknown)(Unknown)(Unkno
wn)3/30/174/4/17Delayed Vendor15ClosedOUSRichmond,
United
Kingdom(Unknown)GVPQualificationQuestionnaireQ1DL(Unkn
own)LG223811/25/171/26/173/2/17(Unknown)(Unknown)(Unkn
own)4/1/174/10/17Delayed Vendor16ClosedOUSChandigah,
India(Unknown)GVPQualificationQuestionnaireQ1DL(Unknown
)LG222231/25/171/26/173/8/17(Unknown)(Unknown)(Unknown
)4/7/173/23/17On-timeVendor17ClosedOUSAuckland, New
Zealand(Unknown)GVPQualificationQuestionnaireQ1DL(Unkno
wn)LG223801/25/171/26/173/8/17(Unknown)(Unknown)(Unkno

9. wn)4/7/174/27/17Delayed Vendor18Not In ScopeOUSVincenza,
ItalyRaw Material Mfg., Starting Material Mfg., DS
Intermediate and/or DS Mfg., DP Intermediate and/or DP Mfg.,
Analytical Services, Microbiology Services Stability Testing
Services, Packaging & Labeling Mfg., Warehouse &
Distribution, Test Articles, Reference
StandardGMPRequalificationNoneQ1GN(Unknown)(Unknown)(
Unknown)2/8/17(Unknown)(Unknown)2/7/172/21/172/24/173/2
6/17(Unknown)(Unknown)Vendor19Not In ScopeOUSPonte
Cremenaga, SwizerlandSpray Dried Dispersion
Dry Powder Inhaler
CharacterizationGMPQualificationNoneQ1GN(Unknown)(Unkn
own)(Unknown)2/8/17(Unknown)(Unknown)(Unknown)(Unkno
wn)(Unknown)(Unknown)(Unknown)(Unknown)Vendor20In
ProgressOUSDudley, United KingdomRaw Material Mfg.,
Starting Material Mfg., DS Intermediate and/or DS Mfg.,
Analytical Services, Microbiology Services, Stability Testing
Services, Packaging & Labeling Mfg., Warehouse &
Distribution, Test Articles, Reference
StandardGMPRequalificationOn
SiteQ1GNTBTB218712/8/17(Unknown)(Unknown)5/4/175/10/1
75/10/176/9/17(Unknown)(Unknown)Vendor21In
ProgressUSAMalvern, PADS Intermediate and/or DS Mfg.,
Analytical Services, Warehouse & Distribution, Test Articles,
Reference StandardGMPRequalificationOn
SiteQ1GNRNDF218752/8/17(Unknown)(Unknown)5/4/176/12/1
76/13/177/13/17(Unknown)(Unknown)Vendor22CompletedUSA
Bensenville, ILWarehouse & Distribution, Brokerage /
TransportationGDPQualificationOn
SiteQ1GNLDSCR218762/8/17(Unknown)(Unknown)Week of 20
Feb2/20/172/21/173/23/173/23/17On-
timeVendor23CompletedUSAHigh Point, NCRaw Material
Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg.,
Analytical Services, Microbiology Services, Stability Testing
Services, Packaging & Labeling Mfg., Warehouse &
Distribution; Test Articles, Reference

10. StandardGMPRequalificationOn
SiteQ2GNLDSDF218792/8/17(Unknown)(Unknown)3/24/174/3/
174/4/175/4/175/4/17On-timeVendor24In ProgressUSACharles
City, IA Raw Material Mfg., Starting Material Mfg., DS
Intermediate and/or DS Mfg., Analytical Services, Microbiology
Services, Stability Testing Services, Packaging & Labeling
Mfg., Warehouse & DistributionGMPQualificationOn
SiteQ2GNLDSAA218802/8/174/20/17(Unknown)5/4/176/20/176
/21/177/21/17(Unknown)(Unknown)Vendor25In
ProgressOUSTokyo, JapanRaw Material Mfg., Starting
Matertial Mfg., DS Intermediate and/or DS Mfg., Analytical
Services, Microbiology Services, Stability Testing Services,
Packaging & Labeling Mfg., Warehouse &
DistributionGMPQualificationOn
SiteQ2GNTBTB220332/8/17(Unknown)(Unknown)5/4/176/26/1
76/27/177/27/17(Unknown)(Unknown)Vendor26PendingOUSJiu
zhou, ChinaRaw Material Mfg., Starting Material Mfg., DS
Intermediate and/or DS Mfg., Analytical Services, Microbiology
Services, Stability Testing Services, Packaging & Labeling
Mfg., Warehouse & DistributionGMPQualificationOn
SiteQ2GNTBTB(Unknown)2/8/17(Unknown)(Unknown)(Unkno
wn)(Unknown)(Unknown)(Unknown)(Unknown)(Unknown)Ven
dor27PendingOUSGoa, IndiaRaw Material Mfg., Starting
Material Mfg., DS Intermediate and/or DS Mfg., Analytical
Services, Microbiology Services, Stability Testing Services,
Packaging & Labeling Mfg., Warehouse &
DistributionGMPQualificationOn
SiteQ2GNTBTB(Unknown)2/8/17(Unknown)(Unknown)(Unkno
wn)(Unknown)(Unknown)(Unknown)(Unknown)(Unknown)Ven
dor28Not In ScopeUSASecaucus, NJComparator/co-medication
purchase;
ability to outsource placebo development and manufacturing to
a third
partyGMPQualificationNoneQ2GN(Unknown)(Unknown)(Unkn
own)2/8/17(Unknown)(Unknown)(Unknown)(Unknown)(Unkno
wn)(Unknown)(Unknown)(Unknown)Vendor29Not In

11. ScopeOUSBrampton, CanadaWarehouse &
DistributionGDPRequalificationQ in
2016Q2GN(Unknown)(Unknown)(Unknown)2/8/17(Unknown)(
Unknown)(Unknown)(Unknown)(Unknown)(Unknown)(Unknow
n)(Unknown)Vendor30Not In ScopeOUSAnkara,
TurkeyWarehouse &
DistributionGDPQualificationNoneQ2GN(Unknown)(Unknown)
(Unknown)2/8/17(Unknown)(Unknown)(Unknown)(Unknown)(
Unknown)(Unknown)(Unknown)(Unknown)Vendor31Not In
ScopeOUSHarsewinkel, GermanyWarehouse &
DistributionGDPQualificationNoneQ2GN(Unknown)(Unknown)
(Unknown)2/8/17(Unknown)(Unknown)(Unknown)(Unknown)(
Unknown)(Unknown)(Unknown)(Unknown)Vendor32Not In
ScopeOUSMoscow, RussiaWarehouse &
DistributionGDPQualificationNoneQ2GN(Unknown)(Unknown)
(Unknown)2/8/17(Unknown)(Unknown)(Unknown)(Unknown)(
Unknown)(Unknown)(Unknown)(Unknown)Vendor33In
ProgressUSAWhippany, NJDP Intermediate and/or DP Mfg.,
Analytical Services, Microbiology Services, Stability Testing
Services, Packaging & Labeling Mfg., Warehouse &
DistributionGMPRequalificationOn
SiteQ2GNSKJR218702/8/17(Unknown)(Unknown)5/3/175/31/17
6/1/177/1/17(Unknown)(Unknown)Vendor34ScheduledUSAWil
mington, NCRaw Material Mfg., Starting Material Mfg., DS
Intermediate and/or DS Mfg., Analytical Services, Microbiology
Services, Stability Testing Services, Packaging & Labeling
Mfg., Warehouse & DistributionGMPRequalificationOn
SiteQ2GN(Unknown)CL(Unknown)2/8/17(Unknown)(Unknown)
6/30/1710/10/1710/11/1711/10/17(Unknown)(Unknown)Vendor
35ScheduledOUSJiande Zhejiang, ChinaRaw Material Mfg.,
Starting Material Mfg., DS Intermediate and/or DS Mfg.,
Analytical Services, Microbiology Services, Stability Testing
Services, Packaging & Labeling Mfg., Warehouse &
Distribution, Test Articles, Reference
StandardGMPRequalificationOn
SiteQ2GNSKAK(Unknown)2/8/17(Unknown)(Unknown)9/27/17

12. 11/27/1711/28/1712/28/17(Unknown)(Unknown)Vendor36In
ProgressUSALancaster, PAAnalytical Services, Microbiology
Testing ServicesGMPRequalificationOn
SiteQ2GNRJCBM218882/8/17(Unknown)(Unknown)8/3/178/31/
178/31/179/30/17(Unknown)(Unknown)Vendor37ScheduledUS
ARockford, ILPkg. & Labeling Mfg., Analytical Services,
Warehouse & DistributionGDPRequalificationOn
SiteQ2GNCTPW218892/8/17(Unknown)(Unknown)9/20/1710/1
2/1710/13/1711/12/17(Unknown)(Unknown)Vendor38In
ProgressOUSDeajeon, KoreaRaw Material Mfg., Starting
Material Mfg., DS Intermediate and/or DS Mfg., Analytical
Services, Microbiology Services, Stability Testing Services,
Packaging & Labeling Mfg., Warehouse &
DistributionGMPRequalificationOn
SiteQ2GNTBTB218902/8/17(Unknown)(Unknown)5/4/176/29/1
76/30/177/30/17(Unknown)(Unknown)Vendor39In
ProgressOUSLoures, PortugalRaw Material Mfg., Starting
Material Mfg., DS Intermediate and/or DS Mfg., DP
Intermediate and/or DP Mfg., Analytical Services, Microbiology
Services, Stability Testing Services, Packaging & Labeling
Mfg., Warehouse & Distribution, Test
ArticlesGMPRequalificationOn
SiteQ2GN(Unknown)WS(Unknown)2/8/17(Unknown)(Unknown
)5/4/179/27/179/29/1710/29/17(Unknown)(Unknown)Vendor40I
n ProgressUSABend, ORStarting Matertial Mfg., DP
Intermediate and/or DP Mfg., Analytical Services, Microbiology
Services, Stability Testing Services, Packaging & Labeling
Mfg., Warehouse & Distribution, Test Articles, Reference
StandardGMPRequalificationOn
SiteQ2GN(Unknown)WS218922/8/17(Unknown)(Unknown)5/2/
178/1/178/2/179/1/17(Unknown)(Unknown)Vendor41Not In
ScopeUSAHighland Park, NJ503a Compounding
ServicesGMPRequalificationNoneQ2GN(Unknown)(Unknown)(
Unknown)2/8/17(Unknown)(Unknown)(Unknown)(Unknown)(U
nknown)(Unknown)(Unknown)(Unknown)Vendor42In
ProgressOUSDartford, United KingdomDS Intermediate and/or

13. DS Mfg., Analytical Services, Warehouse & Distribution, Test
Articles, Reference StandardGMPRequalificationOn
SiteQ3GNTBTB218972/8/17(Unknown)(Unknown)5/4/177/10/1
77/10/178/9/17(Unknown)(Unknown)Vendor43In
ProgressOUSCourroux, SwitzerlandStarting Matertial Mfg., DP
Intermediate and/or DP Mfg., Analytical Services, Microbiology
Services, Stability Testing Services, Packaging & Labeling
Mfg., Warehouse & DistributionGMPRequalificationOn
SiteQ3GNSKAA219002/8/17(Unknown)(Unknown)6/30/179/18/
179/19/1710/19/17(Unknown)(Unknown)Vendor44In
ProgressOUSLatina, ltalyStarting Matertial Mfg., DP
Intermediate and/or DP Mfg., Analytical Services, Microbiology
Services, Stability Testing Services, Packaging & Labeling
Mfg., Warehouse & DistributionGMPRequalificationOn
SiteQ3GNJRES219012/8/17(Unknown)(Unknown)6/30/179/21/1
79/22/1710/22/17(Unknown)(Unknown)Vendor45CancelledUSA
Knoxville, TNAnalytical
ServicesGMPRequalificationNoneQ3GNEZPW219022/8/17(Unk
nown)(Unknown)6/26/179/19/179/19/1710/19/17(Unknown)(Un
known)Vendor46PendingUSABrooks, KYPkg. & Labeling Mfg.,
Warehouse & DistributionGMP/GDPRequalificationOn
SiteQ4GNVendor3(Unknown)(Unknown)2/8/17(Unknown)(Unk
nown)(Unknown)(Unknown)(Unknown)(Unknown)(Unknown)(
Unknown)Vendor47PendingUSAReno, NVPkg. & Labeling
Mfg., Warehouse & DistributionGMP/GDPRequalificationOn
SiteQ4GNVendor3(Unknown)(Unknown)2/8/17(Unknown)(Unk
nown)(Unknown)(Unknown)(Unknown)(Unknown)(Unknown)(
Unknown)Vendor48ScheduledUSAHorsham, PADP Intermediate
and/or DP Mfg., Analytical Services, Microbiology Services,
Stability Testing Services, Packaging & Labeling Mfg.,
Warehouse & DistributionGMP RequalificationOn
SiteQ4GN(Unknown)WS(Unknown)2/8/17(Unknown)(Unknown
)9/14/1710/24/1710/25/1711/24/17(Unknown)(Unknown)Vendor
49PendingOUSRydalmere, AustraliaWarehouse &
DistributionGDPRequalificationQuestionnaireQ4GN(Unknown)(
Unknown)(Unknown)2/8/17(Unknown)(Unknown)(Unknown)(U

14. nknown)(Unknown)(Unknown)(Unknown)(Unknown)Vendor50
CancelledUSASomerset, NJStarting Matertial Mfg., DP
Intermediate and/or DP Mfg., Analytical Services,
Microbiology Services, Stability Testing Services, Packaging &
Labeling Mfg., Warehouse & DistributionGMP
RequalificationNoneQ4GNRNBM219072/8/17(Unknown)(Unkn
own)8/3/179/19/179/20/1710/20/17(Unknown)(Unknown)Vendo
r51PendingOUSVisp, SwitzerlandRaw Material Mfg., Starting
Material Mfg., DS Intermediate and/or DS Mfg., DP
Intermediate and/or DP Mfg., Analytical Services, Microbiology
Services, Stability Testing Services, Packaging & Labeling
Mfg., Warehouse & Distribution and Cell Bank StorageGMP
RequalificationOn
SiteQ4GN(Unknown)TB(Unknown)2/8/17(Unknown)(Unknown)
(Unknown)(Unknown)(Unknown)(Unknown)(Unknown)(Unkno
wn)Vendor52In ProgressUSAColumbia, SCStarting Matertial
Mfg., DP Intermediate and/or DP Mfg., Analytical Services,
Microbiology Services, Stability Testing Services, Packaging &
Labeling Mfg., Warehouse & DistributionGMP
RequalificationOn
SiteQ4GN(Unknown)DF219112/8/17(Unknown)(Unknown)8/3/1
79/26/179/27/1710/27/17(Unknown)(Unknown)Vendor53Not In
ScopeOUSStarnberg, GermanyDevice Mfg.GMP
Qualification(Unknown)Q4GN(Unknown)(Unknown)(Unknown)
2/8/17(Unknown)(Unknown)(Unknown)(Unknown)(Unknown)(
Unknown)(Unknown)(Unknown)Vendor54Not In
ScopeUSAMidlothian, VADevice Mfg.GMP
Qualification(Unknown)Q4GN(Unknown)(Unknown)(Unknown)
2/8/17(Unknown)(Unknown)(Unknown)(Unknown)(Unknown)(
Unknown)(Unknown)(Unknown)Vendor55ClosedUSAMason,
OHPathology servicesGLPQualificationOn
SiteQ1MMRDCL231312/9/175/8/175/19/173/31/175/24/175/24/
176/23/176/23/17On-timeVendor56Not In ScopeUSALenexa,
KSBioanalyticalGLPRequalificationNoneQ1MM(Unknown)(Un
known)(Unknown)2/9/17(Unknown)(Unknown)(Unknown)(Unk
nown)(Unknown)(Unknown)(Unknown)(Unknown)Vendor57Not

15. In ScopeOUSMontreal, CanadaGenetal Toxicology
Drug Metabolism
ToxicokineticsGLPRequalificationNoneQ2MM(Unknown)(Unkn
own)(Unknown)2/9/17(Unknown)(Unknown)(Unknown)(Unkno
wn)(Unknown)(Unknown)(Unknown)(Unknown)Vendor58Not
In ScopeOUSQuebec City,
CanadaToxicokineticsGLPRequalificationNoneQ2MM(Unknown
)(Unknown)(Unknown)2/9/17(Unknown)(Unknown)(Unknown)(
Unknown)(Unknown)(Unknown)(Unknown)(Unknown)Vendor5
9In ProgressOUSAssen, New
ZealandBioanalyticalGLPRequalification/QOn
SiteQ2MMOGAK(Unknown)2/9/17(Unknown)(Unknown)6/29/1
79/19/179/21/1710/21/17(Unknown)(Unknown)Vendor60Schedu
ledUSASterling, VAArchival ServicesGLPRequalificationOn
SiteQ3MMRDAA(Unknown)2/9/17(Unknown)(Unknown)6/16/1
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Student Assignment – Audits Data Analysis
Overview and Rationale
Being able to ask appropriate questions of data is an important
part of the work of data analytics. It is also critical to be able to
interpret the results of the analysis. This assignment is intended
to familiarize you with the Audits data set and to get you
thinking about key business questions you can answer from this
data.
Course Outcomes

20. This assignment is directly linked to the following learning
outcomes from the course syllabus:
· Visualize data in a compelling way to enable data driven
storytelling.
· Conduct basic analytic tasks programmatically using the R
language*
· R is not required for this assignment, but you may choose to
use it if you feel confident in your R skills
Assignment Summary
There are two Excel sheets with data – one concerning "Good
Working Practice” audits (GWP_Audits_Data) and one
concerning “Computerized System Quality Assurance” audits
(CSQA_Audits_Data). Please see the accompanying Data
Dictionary to understand the fields and values.
You may use any software to perform the analyses specified
below. Collaboration is encouraged, but you must not submit
identical assignments.
The assignment has three parts. In the Appendix of this
assignment, you are provided an example of how the questions
in Part I should be answered.
Part I
Please review the Vertex Data Dictionary document as you
review the Excel datasheets.
In order to understand the data we first need to run some
descriptives on the data set. For both the GxP Audits and the
CSQA Audits sheets, we want to look at the following
variables:
· Audit Status
· In USA or OUS
· GxP Area
· Audit Type
· Audit Method
· Proposed Quarter
Start by providing the following for each variable:
1. A table that provides the frequency and percent of each value
2. A graphic representation of the count of each value

21. 3. A graphic representation of the percent of each value
4. What business question do your descriptive analyses answer?
Provide a brief discussion of the findings. If there are any
unusual values, discuss them. Are these values “out of range”?
If so, the data cleaning is not complete. Delete the out of range
values and run the analysis again. If this is the case for any of
the variables, present both the analysis with the out of range
values and the analysis with the deleted out of range value.
Please first present your findings for the 2017 GxP Audits data
and then the findings for the 2017 CSQA Audits data.
Note: Appendix 1 is only an example and you must complete
your own analysis.
Part II
For each worksheet, compute the number of days lapsed
between:
1. “Date of Intake” and “Date Q Sent”. Name that variable
“Days_Intake_QSent”
2. “Date Q Sent” and “Date Q Received”. Name that variable
“Days_QSent_QReceived. Based on the name of the variables,
what do you think that variable means? Does it apply to all
audits? Why?
3. “Date On Site Scheduled” and “Audit Start Date”. Name that
variable “Days_OnSiteScheduled_AuditStartDate. Does this
variable apply to all audits? Why?
4. “Audit Start Date and “Audit End Date”. Name that variable
“Days_StartDate_EndDate”.
5. “Audit End Date” and “Date Final Report Due”. Name that
variable “Days_AuditEnd_FinalReportDue”
6. “Date Final Report Due” and “Date of Completion”. Name
that variable “Days_FinalReportDue_CompletionDate”
Then, compute the mean and median for each of the 6 variables
you have computed.
Part III
Would you recommend merging the sheets “2017 GxP Audits”
and “2017 CSQA” Audits? Why or why not?

22. Page 5 of 5
Rubrics
Category
Exceeds Standards
Meets Standards
Approaching Standards
Below Standards
Descriptives
ALY6000-CO5
Accurately visualizes data in an innovative and compelling way
that tells a story.
Accurately and creatively visualizes data in a useful way that
tells a story.
Visualizes data in a useful way but visualizations may not be
creative, or may have errors.
Data visualizations are actuate, but not visually appealing and
hinder the story being told.
Data Analysis
ALY6000-CO1
Correctly calculates all values based on the data and highlights
each mean and median value.
Correctly calculates all values based on the data, including the
mean and median values
Calculates values, but not all are correct or does not include
mean and median values
Does not calculate all required values and does not include
mean and median values
Recommendations
ALY6000-CO4
Makes compelling recommendations supported by coherent and
valid reasoning.
Makes appropriate recommendations supported by logical
reasons
Makes good recommendations, but reasoning is obscure or not
valid

23. Recommendations do not make sense given the reasons
provided or recommendations are not supported by reasons.
Writing and Format
Assignment follows normal conventions of grammar and
spelling and appropriate conventions of style and format that
engages the reader
Assignment work follows normal conventions of grammar and
spelling and has been carefully proofread. Appropriate
conventions of style and format are used consistently.
Minimal errors in spelling, and grammar, and/or other writing
conventions. Some transitions are choppy but not difficult to
follow.
Frequent errors in spelling, grammar, and/or other writing
conventions that distract the reader. Transitions are choppy and
difficult to follow. Limited connection to the topic.
Appendix
Assignment Part I Section a Example
Business Question:
What is the distribution of the status of the 2017 GxP Audits?
Analysis:
Descriptives Table
Audit Status
Frequency
Percent
Valid Percent
Valid
Closed
19

24. 19.8
19.8
Completed
4
4.2
4.2
In Progress
18
18.8
18.8
Scheduled
11
11.5
11.5
Pending
14
14.6
14.6
Not In Scope
26
27.1
27.1
Cancelled
4
4.2
4.2
Total
96
100.0

25. 100.0
Audit Status Count
Audit Status Percentages
Discussion:
The data file includes information on 96 audits in 2017 for GxP
areas. It is unclear if the data file includes all the known GxP
audits in 2017 or if it only includes a subset.
A large percentage of all GxP Audits (27.1%) are not in scope.
19.8% of audits are closed and 4.2% of audits are completed. It
is unclear what the difference between “closed” and
“completed” audits is. We should perhaps ask the client. Do we
really need two distinct values?
18.8% of the audits are in progress, 11.5% are scheduled and
14.6% are pending. For the pending audits, the dates of the
audit process have not been established.
4.2% of the audits were canceled. It may be interesting to have
a notes field where the reasons for cancelation are noted.