DIAGRAM01_PORTES-TargetStateDiagram.pdf

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DataFit v1.0, Portes v1.0 Migration Group: N/A Bundle: N/A

The Portes project:

1. Automates the loading of incoming study data into a single repository for downstream uses (instead of manually copying study data by Reviewers, tools, and CDER OBI eDATA Review Team to many staging areas)

2. Performs revision control for study data by study ID

3. Provides a single and consistent view of many versions of studies to Reviewers

4. Allows existing COTS tool (e.g., JMP) to access the up-to-date study data thus facilitate correct reviews of sponsors’ submissions The DataFit project:

1. Automates the validation of data loaded into Portes for quality and compliance review

2. Provides reports to reviewers and other users to help them assess issues with submitted study data

Description

Communications & Dependencies

Enterprise Services

Key Contacts

External Dependencies

Security Bucket

Version: 1 Last Modified: 06/30/2014

CDER_Portes_DataFit_TSD_PREPROD-PROD.vsd

Modification Tasks

M od ifi ca tio n

Ta sk s D ur in g M ig ra tio n

Load Balancer

Oracle RAC Solaris 10

Solaris 10 Server

Windows Server

SAS DD

Shared Area

(~100GB)

SAS DD

Repository

(Study Data) (~.3 to 1TB)

WODC

SMTP

LDAP

database

RemoteAPI – cacert – certificate installed

FDA Intranet

Load Balancer

Software: Oracle Database Server 10G R2

Xythos drive map

2 Load Balancer to Load Balancer for WebLogic server

Windows Server to Electronic Document Room (via SAS SDD v3.5)6

CDER DataFit – Target State Diagram for Prod Environment

WebLogic/SAS SDD Application Server to Windows Server

Software: SAS DD 3.5 (File Conversion), Portes Crawler (custom)

Electronic Document Room

5 WebLogic/SAS SDD Application Server to Oracle DB Server

7 Web server to LDAP

1 Outgoing SMTP Server

Client Workstation to the Load Balancer Regular Portes Reviewers connect to SAS DD Repository (configured as virtual drive via Xythos Client SW) by client tools such as JMP, retrieves file, and performs analysis on user’s desktop. Communication ends. Connection is made through Web Zone Load Balancer.

3 App Zone Load Balancer routes portes to WebLogic/SAS SDD Application server

Software: Oracle WebLogic 9.2.3, SAS Drug Development 3.5

Remote API connects to SAS SDD WebLogic Server via Load Balancer on App zone.

1a

Integration (Remote API)

1a

2 Database connecting to Oracle Client –

Windows Server to SDD Weblogic 8

Software: OpenCDISC Enterprise Web Server/Validation Application

Software: MongoDB 2.6

Administrator / User

1 DataFit users and administrators connect to OpenCDISC Enterprise (DataFit) web zone load balance

OpenCDISC Enterprise validation application to MongoDB for storing diagnostic information

3 F5 Load Balancer to OpenCDISC Enterprise web server

2 Web zone load balancer connects to application zone load balancer

OpenCDISC Enterprise web server and validation application connect to Oracle DB server

C lie nt

W or ks ta tio n

W eb

Z on e A pp lic at io n Zo ne D at a

Zo ne

DataFit v1.0, Portes v1.0 Migration Group: N/A Bundle: N/A

The Portes project:

1. Automates the loading of incoming study data into a single repository for downstream uses (instead of manually copying study data by Reviewers, tools, and CDER OBI eDATA Review Team to many staging areas)

2. Performs revision control for study data by study ID

3. Provides a single and consistent view of many versions of studies to Reviewers

4. Allows existing COTS tool (e.g., JMP) to access the up-to-date study data thus facilitate correct reviews of sponsors’ submissions The DataFit project:

1. Automates the validation of data loaded into Portes for quality and compliance review

2. Provides reports to reviewers and other users to help them assess issues with submitted study data

Description

Communications & Dependencies

Enterprise Services

Key Contacts

External Dependencies

Security Bucket

Version: 1 Last Modified: 06/30/2014

CDER_Portes_DataFit_TSD_PREPROD-PROD.vsd

Modification Tasks

M od ifi ca tio n

Ta sk s D ur in g M ig ra tio n

Load Balancer

Oracle RAC Solaris 10

Solaris 10 Server

Windows Server

SAS DD

Shared Area

(~100GB)

SAS DD

Repository

(Study Data) (~.3 to 1TB)

WODC

SMTP

LDAP

database

RemoteAPI – cacert – certificate installed

FDA Intranet

Load Balancer

Software: Oracle Database Server 10G R2

User / Xythos drive map

2 Load Balancer to F5 Load Balancer for WebLogic server

Windows Server to Electronic Document Room (via SAS SDD v3.5)6

CDER DataFit – Target State Diagram for Prod Environment

WebLogic/SAS SDD Application Server to Windows Server

DB Instance: PORTESP

Software: SAS DD 3.5 (File Conversion), eData Portes Crawler (custom)

Electronic Document Room

5 WebLogic/SAS SDD Application Server to Oracle DB Server

7 Web server to LDAP

1 Outgoing SMTP Server

Client Workstation to the Load Balancer Regular Portes Reviewers connect to SAS DD Repository (configured as virtual drive via Xythos Client SW) by client tools such as JMP, retrieves file, and performs analysis on user’s desktop. Communication ends. Connection is made through Web Zone load Balancer.

3 App Zone Load Balancer routes portes to WebLogic/SAS SDD Application server

Software: Oracle WebLogic 9.2.3, SAS Drug Development 3.5

Remote API connects to SAS SDD WebLogic Server via F5 Load Balancer on App zone

1a

Integration (Remote API - WebDav)

1a

2 dataase – Oracle Client

Windows Server to SDD Weblogic 8

Software: OpenCDISC Enterprise Web Server/Validation Application

Software: MongoDB 2.6

Administrator / User

1 DataFit users and administrators connect to OpenCDISC Enterprise (DataFit) web zone load balancer

OpenCDISC Enterprise validation application to MongoDB for storing diagnostic information

3 Load Balancer to OpenCDISC Enterprise web server

2 Web zone load balancer connects to application zone load balancer

OpenCDISC Enterprise web server and validation application connect to Oracle DB server