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Implementation Guide
8.3
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Document: Pega Foundation for Life Sciences Implementation Guide
Publication date: September 06, 2019
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ii | Implementation Guide
Contents
Contents
Application overview................................................................................................................................................................................. 5
Building features........................................................................................................................................................................................8
Implementing case types and attributes.................................................................................................................................................8
Adding case types.........................................................................................................................................................................8
Mapping case type or data type classes to a database table................................................................................................ 8
Application data model.............................................................................................................................................................................. 9
Adding properties to data types................................................................................................................................................ 9
Using the MedDRA data model.............................................................................................................................................................. 10
Updating the MedDRA database and tables.......................................................................................................................... 10
Configuring the MedDRA browse in cases..............................................................................................................................11
Configuring the Medicinal products data model................................................................................................................................. 11
Configuring database tables..................................................................................................................................................... 11
Configuring the Medicinal products browse UI......................................................................................................................12
Configuring WHODD format types...........................................................................................................................................12
Configuring Field-level auditing.............................................................................................................................................................. 13
Selecting field-level auditing flows........................................................................................................................................... 13
Configuring properties for audit functions to ignore............................................................................................................13
Additional field-level auditing configuration........................................................................................................................... 14
Configuring auditable notifications........................................................................................................................................................ 14
Generating external assignments.............................................................................................................................................14
Configuring external assignments............................................................................................................................................15
Using the PDF eForms Accelerator........................................................................................................................................................ 16
Using the Generate from Existing PDF eForms module....................................................................................................... 16
Using the Generate from New PDF eForms module.............................................................................................................16
Implementing the security model and organization structure.......................................................................................................... 17
Implementing your authentication scheme............................................................................................................................17
Authorization scheme................................................................................................................................................................ 17
Defining your access groups.......................................................................................................................................18
Defining access roles and privileges..........................................................................................................................18
Configuring your organization structure................................................................................................................................. 18
Operator attributes.................................................................................................................................................................... 18
Configuring the operator work group....................................................................................................................... 18
Configuring the operator skills................................................................................................................................... 19
Configuring the operator calendar............................................................................................................................ 19
Customizing the user experience...........................................................................................................................................................19
Designing an application skin and styles................................................................................................................................ 19
Designing for screen performance.......................................................................................................................................... 20
iv | Implementation Guide
Application overview
Application overview
The Pega Foundation for Life Sciences application provides industry-specific modules for rapid
deployment of solutions across your organization. The following reusable modules automate and
optimize key business processes.
Field-level auditing
• Supports the life sciences regulatory requirements for audit and authentication purposes in any Pega
application.
• Enables auditing and authentication support with integrated audit trails.
• Improves compliance and reduces the compliant applications development effort.
Implementation Guide | 5
Preparing for the implementation
On the Organization landing page, create a customer organizational structure. The organization
structure is required so that the new application will have the appropriate class structure. For more
information, see the Organization chart tab on the Organization landing page.
Caution: If a Pega Foundation for Life Sciences application already exists in your system,
running the New Application wizard overwrites some existing application settings. This will cause
issues with your existing application. Having more than one active Pega Foundation for Life
Sciences application on the same Pega Platform instance is not supported. This includes custom
applications built by you and sample applications provided by Pega.
1. To create a new operator ID for running the New Application wizard, complete the following steps:
a. Log in to Dev Studio by using the operator ID administrator@pega.com and the password that
you specified for that operator.
b. Save a copy of the existing administrator@pega.com operator, and give it a name that identifies
it as an Application Setup operator.
c. Add the PegaLSIF:AppSetup access group to the new operator record, and then click the radio
button to the left of the access group to select it as the default access group.
When this access group is selected as the default access group, the New Application wizard opens
immediately when this operator logs in.
d. On the Work tab, update the organizational unit to point to the organizational structure created as
part of the prerequisite steps.
e. Save the new Application Setup operator.
2. Log in as the Application Setup operator.
3. Follow the New Application wizard instructions.
4. Click Go to app.
The New Application wizard creates a set of access groups for the application. Create your own operators,
and then apply the appropriate access groups.
The New Application wizard creates the application class structure for you. For more information, see
Class layers and class hierarchy and inheritance.
After you create your application, enable and extend configurable functionality and features to meet
your business needs. To learn more about the application, click Resources in the upper-right corner
of the Dev Studio or App Studio screen.
6 | Implementation Guide
Preparing for the implementation
Implementation Guide | 7
Building features
Building features
The implementation team enables or extends features to meet your business requirements.
To configure application features, review the topics in the following sections:
8 | Implementation Guide
Building features
Data types
Data type is another name for a class in your application. It holds data that the application uses. A data
type has one or more data pages and several property definitions associated with it.
Properties
Properties define the format and visual presentation of data in your application.
Data pages
Data pages define the content of a clipboard page. Data pages also control the loading of that data
from a source system, as shown here.
When planning your data model, work with the data modeling resource at your site to understand the
attributes of the data types that need to be supported by your application.
Implementation Guide | 9
Building features
If you need to fetch the data from an already existing MedDRA database, update the Data-Admin-
DB-Table instances for MedDRA tables.
10 | Implementation Guide
Building features
1. Click Dev Studio Explorer panel > Records > Sysadmin > Database Table and search for the
database table instance that you want to update, for example: PegaLS-FW-Int-UNIINames.
Implementation Guide | 11
Building features
To configure the WHODD tables, search for the PegaLS-Int-WHO-Drug-C- class in the Data-
Admin-DB-Table instances. All of the WHODD specific instances will be visible there.
1. Create database tables required for the B2 format. You can load the data into the tables from the flat
files using control files that are a part of the WHODD licensed data dictionary.
2. Click Dev Studio > Data Model > Classes & Properties > Database Class Mappings and create the
corresponding class and properties for each table, using the New External Database Class Mapping
wizard.
3. Fill in all the necessary fields in all the presented steps and click Submit.
4. In the Dev Studio header search field, enter WHODDFormatSetting and select the Code-Pega-List
map value from the results.
5. Save the rule into your implementation layer. For additional information about locked and unlocked
rulesets, see Copying a rule or data instance.
6. Set the WHO_DD_Format format type value to B2.
7. Click Save.
8. In the Dev Studio header search field, enter DPLoadProductResults and select the Code-Pega-List
activity from the results.
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Building features
9. Extend the GetB2FormatResults stub activity to fetch the data from B2 format tables.
3. Select the AUDIT? checkbox next to the flow action you want to configure auditing for.
4. Click Configure Auditing to confirm the assignment.
• Pre and post activities are automatically added to flow actions on the Action tab to capture audit
events.
• Audit buttons are added to all sections references in the selected flow actions to support audit
functions. For more information, see Additional field-level auditing configuration.
• The IgnoreFromAuditing data transform rule is added. For more information, see Configuring
properties for audit functions to ignore.
1. In the Dev Studio header search field, enter IgnoreFromAuditing and select the Work- class data
transform from the results.
2. Save the rule into your implementation layer. For additional information about locked and unlocked
rulesets, see Copying a rule or data instance.
3. Add all of the properties that the auditing functionality ignores.
4. Click Save.
Implementation Guide | 13
Building features
1. In the Dev Studio header search field, enter LSFieldAuditSettings and select the @baseclass map
value from the results.
2. Save the rule into your implementation layer. For additional information about locked and unlocked
rulesets, see Copying a rule or data instance.
3. Configure each column and row based on your business requirements.
AuthenticationMode
Determines if the electronic signature is mandatory while making changes to the auditing
properties. Set to None to disable authentication, or leave as Simple Auth to use ID and password
for authentication.
ReasonsForChangeReqd
Determines if entering reasons is mandatory while making changes to the auditing properties. Set
to None to disable mandatory reasons field, or leave as All to enable.
BypassConfirmation
Determines if the modal dialog for changes confirmation is displayed or not. Set to false to
disable, or true to enable.
ShowAuditButtons
Determines if the View Audit History and Review and Confirm Audited Modifications buttons
are displayed or not. Set to false to hide, or leave as true to show the buttons.
4. Click Save.
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Building features
3. Add a row for each external assignment rule that you want to generate and enter the parameters
based on the suggestions given below:
4. To create rules and automatically populate the remaining fields on the display click Generate External
Assignment Rules.
1. Click Dev Studio > Org & Security > Organization > Operators and search for the Data-Admin-
Operator-ID instance External operator.
2. Double-click the External operator ID to open it.
3. On the Security tab, ensure that the License type value is set to Invocation.
4. In the Dev Studio Explorer panel, click Records > Integration Resources > Email Account.
5. Ensure that the Default instance of Data-EmailAccount is set up to successfully send the emails. You
can open this instance and click Test connectivity to check the configuration status.
The external assignment (local action that was generated by the landing page) should be included
in the appropriate assignment of the main process flow. The email IDs of all the external users to
whom the assignments are to be sent are provided in this local action. When the local action is
submitted, each external user receives a different instance of the external assignment. The Work-
class EngageExternalQuickMultiple flow is automatically invoked to send emails to the external
users.
Each external user receives two emails, one with a unique link to their assignment and a second
with a randomly generated password for authentication. The GeneratePassword function of
ExternalAssignmentsLS library generates the random password.
External user’s responses can be tracked using reports that are available upon completion status.
For more information about external assignments, see External assignments through Directed Web
Access.
To display the external assignments that have been sent as notifications for a work object use the
DisplayExternalAssignments section rule in the Work class.
1. In the Dev Studio header search field, enter DisplayExternalAssignments and select the
Work- section rule from the results.
Implementation Guide | 15
Building features
2. Save the rule into your implementation layer. For additional information about locked and
unlocked rulesets, see Copying a rule or data instance.
3. Click Save.
1. Click Dev Studio > Life Sciences > LS Reports > Generate from Existing PDF eForms .
2. Fill in all the required fields, such as: Ruleset, Ruleset version, Applies to Class, and PDF Report
Name associated with your work object.
3. From the Activity Applies to Class list, select where you want to create the activity.
4. Enter the new activity name.
5. For each of the listed eForm Field name instances, enter the appropriate Mapped Application
Property value to populate the form fields.
Normal string formatting operations, such as concatenation (+) and new line character (\n), are
supported. Surround these characters with double quotes, for example: "+".
6. To create the activity in your selected class, click Generate eForm Activities.
1. Click Dev Studio > Life Sciences > LS Reports > Generate from New PDF eForms .
2. Fill in all the required fields associated with your work object.
• New Data Class Name (Data-)
◦ If you enter xyz as a class name, the new data class will be named Data-xyz.
• Ruleset
• Applies to Class
◦ The eForm file and Map eForm rules are created in the class you select. Choose this class at the
class group level to use the same rules across the work types.
• New Page Property Name
◦ A form page property name.
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Building features
• Ruleset version
3. Click Browse and search for the template in your local directory.
4. Click Upload PDF and Continue.
5. Select the Activity Applies to Class based on where you want to create the activity.
6. Enter the new activity name.
7. For each of the listed eForm Field name instances, enter the appropriate Mapped Application
Property value to populate the form fields.
Normal string formatting operations, such as concatenation (+) and new line character (\n) are
supported. Surround these characters with double quotes, for example: "+".
8. To create the activity in your selected class, click Generate eForm Activities.
Authentication
Proves to the application that you are who you say you are.
Authorization
Determines the functions that you can perform in the application. This corresponds to an access group
and role configuration.
Security planning also involves setting up the organization structure and operator attributes. The
application provides security in the form of access settings and denial rules. Many integration rules also
incorporate authentication.
For more information about the additional aspects of security, enroll in the Lead System Architect course on
Pega Academy and cover the Security lessons that correspond to the following topics:
1. Discuss Authentication schemes with your site's security and application server teams.
2. Determine the appropriate authentication type.
For more information on authentication scheme planning, see Authentication in Pega Platform.
Authorization scheme
Pega Foundation for Life Sciences comes with a predefined set of access groups, roles, and privileges.
You can use the application roles as a starting point, but you should create your own application-specific
access groups and roles to avoid any future problems when upgrading.
Other rule types such as sections, flow actions, and activities use roles and privileges to allow access to
these rules at run time.
Implementation Guide | 17
Building features
1. Identify additional access groups that are needed for your application.
2. Identify portals associated with these access groups.
For more information, see Viewing access groups and operators.
1. In the header of Dev Studio, click Configure > Org & Security > Organization > Organizational Chart.
2. Review the existing structure.
3. Determine the organization, division, and unit levels of the hierarchy.
Operator attributes
An operator's access group affects what the operator can do in the application. In addition to the access
group, the following fields in the operator record influence how the application handles assignment of
work to the user:
• Work group
• Skills
• Calendar
Tip: In many implementations, it is more efficient for the application to set values in the operator
record during the authentication process than it is to have an administrator manually maintain
these records. These rules must be configured as part of the authentication mechanism for your
site. For more information, see Authentication services.
For more information, see Operators.
1. In the header of Dev Studio, click Configure > Org & Security > Organization > Operators.
18 | Implementation Guide
Building features
1. Determine the calendar instances that are needed for your application.
2. Determine which operator roles need a distinct calendar.
3. Determine the operator location.
For more information, see More about Calendar data instances.
1. In the header of Dev Studio, click Configure > User Interface > Skins, interfaces, & templates.
2. On the Skins tab, double-click the pyEndUser skin.
Implementation Guide | 19
Building features
20 | Implementation Guide
Packaging a new application
1. In the header of Dev Studio, click Configure > Application > Distribution > Package to start the
Application Packaging wizard. For information about using the wizard, see Product rules.
2. Complete each page of the Application Packaging wizard.
3. On the last page of the wizard, click Preview.
4. Review the contents of the generated RAP file.
5. On the last page of the wizard, click Modify to make any changes.
6. When the RAP file is complete, click Export.
The wizard creates a .ZIP file in the ServiceExport directory on the current application server node.
Implementation Guide | 21
Testing a new application
1. Run functional tests to test specific features from the end-user perspective.
2. Use the Performance tool to measure the performance of the application. For more information, see
Track system utilization for a requestor session with Performance Analyzer.
• Prior to extending your site-specific Pega implementation, establish a performance benchmark
(baseline) by using the Performance tool. This allows subsequent, iterative performance tests
against the baseline to help identify any degradation in performance resulting from development
efforts.
• Use the Performance tool to check the performance of the following features:
◦ Search
◦ Account selection
◦ Loading of components
◦ Kickoff of all service intents. For this unit testing, automated scripts are recommended but not
required.
• Save the test results so that you can compare them to future test results to determine whether an
application update has a performance impact.
3. Verify that the Pega-provided reports and your custom reports run successfully, and that they show
your implementation layer data, rather than the default demonstration data. This can be an automated
test.
4. Test all integrations, both independently and with associated integrations.
Test integrations for any optional Pega Foundation for Life Sciences components and other
applications that you plan to use. See the product documentation for the component or application to
determine which product components to test.
5. Test security. Test the most common roles to ensure that the required access groups are configured
and point to the correct software version.
1. Verify that the source and the destination files are the same.
2. Run functional tests to test specific features from the user perspective.
3. In the test or production environment, run the Application Guardrails Compliance Score to ensure that
the application meets guardrails.
22 | Implementation Guide
Testing a new application
4. Verify that the Pega-provided reports and your custom reports run successfully, and that they show
your implementation layer data, rather than the default demonstration data. This can be an automated
test.
5. Test all integrations, both independently and with associated integrations.
Test integrations for any optional Pega Foundation for Life Sciences components and other
applications that you plan to use. See the product documentation for the component or application to
determine which product components to test.
6. Verify that the integrations point to the correct system of record, and not to the system of record for
the Build environment.
7. Test security. Test the most common roles to ensure that the required access groups are configured
and point to the correct software version. Use these common roles in your smoke tests (see next step).
8. Run a smoke test to compare the source and destination environments. Verify that all tests that pass
in the Build environment also pass in the test or production environment. If anything fails, compare
the environments to determine whether a difference in environment could cause the test to fail. If
the environment caused the failure, either fix the issue that caused the failure or adjust the test as
appropriate for the new environment.
9. Run performance tests to verify that performance meets expectations. Pega recommends automated
performance testing. Save the results so that you can compare them to future performance test results
to determine whether an application update has a performance impact.
Implementation Guide | 23
Production maintenance and monitoring
1. Identify operational staff who will be responsible for responding to issues reported in the production
environment.
2. Establish procedures with those resources to triage, respond to, and escalate issues.
3. Determine procedures for delivery of changes to the production environment.
24 | Implementation Guide