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Pega Foundation for Life Sciences PRODUCT OVERVIEW 7.31
Pega Foundation for Life Sciences
PRODUCT OVERVIEW 7.31
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Pega Foundation for Life Sciences
Document: Product Overview
Software Version: 7.31
Updated: July 2017
CONTENTS
Product overview ................................................................................................ 1 Intended audience ........................................................................................... 1
High level functionality ....................................................................................... 2 LS field auditing ............................................................................................... 2 LS reports ........................................................................................................ 3 LS MedDRA codes .......................................................................................... 3 LS product browse .......................................................................................... 3 LS auditable notifications ................................................................................ 3
Business use cases ............................................................................................ 4 Use case 1: LS field auditing ........................................................................... 4
What the Audit Trail Accelerator does ....................................................... 4 How auditing affects the user interface and processing ............................ 4 Additional options for field auditing ............................................................ 8
Use case 2: LS reports .................................................................................... 8 What the feature does ............................................................................... 9
Use case 3: LS MedDRA codes ...................................................................... 9 What the feature does ............................................................................... 9 Browsing terms and codes ........................................................................ 9 Searching for terms and codes................................................................ 10
Use case 4: LS product browse .................................................................... 11 What the feature does ............................................................................. 11 Browsing products ................................................................................... 11
Use case 5: Pega Foundation for Life Sciences auditable notifications ........ 14 What the feature does ............................................................................. 14
Pega Foundation for Life Sciences - Product Overview 1
This guide is designed to provide users with an overview of the Pega® Foundation for Life Sciences application. This document includes business use cases that describe how the features provided by Pega Foundation for Life Sciences can support and accelerate the development of Pega Platform 7.3 solutions for various aspects of the life sciences industry. This guide explains how to
Provide support for FDA 21 CFR Part 11 audit trail requirements
Quickly generate PDF-based regulatory forms from Pega 7.3 applications
Support MedDRA coding in Pega 7.3 applications
Product browse in Pega 7.3 applications
Authenticate and track external process participants in Pega 7.3 flows
Preview application features using a pre-configured demo application
Product browse feature usage
Intended audience This guide is intended for business users and business analysts and gives a conceptual overview of the basic use cases of Pega Foundation for Life Sciences and its concepts.
Product overview
Pega Foundation for Life Sciences - Product Overview 2
Pega 7.3 is an ideal platform for delivering different types of solutions across the life sciences industry. The platform provides a good balance for the sometimes opposing application development needs of the industry: control and auditability for data versus variation and flexibility for business rules and processes.
The Pega Foundation for Life Sciences application provides building blocks for life sciences applications. Each foundation feature is accessible through the LS Foundation landing page options displayed on the Designer Studio.
LS field auditing This feature is designed to control the modification of information and provide comprehensive audit records in accordance with FDA 21 CFR Part 11—commonly referred to as “Part 11.” US Food and Drug Administration (FDA) regulations include strict requirements about access to electronic records, how changes to those records must be authenticated, and how records of those changes must be captured and maintained.
Pega 7.3 alone provides much of the baseline capability in this area, particularly from a user access and permissions perspective. However, Pega Foundation for Life Sciences includes the FDA Part 11 Audit Trail Accelerator that enables the support of strict user-level and field-level audit logs required by Part 11.
High level functionality
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LS reports This feature streamlines the generation of PDF-formatted regulatory forms—such as FDA 1571 or 1572—from data captured in Pega 7.3 applications. This satisfies a common need of many life sciences workflows to produce a wide range of PDF electronic forms for regulatory submissions or distribution of reports.
The PDF eForm Mapping Accelerator builds on the Pega 7.3 PDF eForm connector to provide rapid creation of generated PDF regulatory forms.
LS MedDRA codes This feature provides integrated Medical Dictionary for Regulatory Activities (MedDRA) coding support for Pega 7.3 applications. MedDRA is a common requirement for safety/pharmacovigilance applications. For example, adverse events (AEs) must be coded with MedDRA for submission to the FDA.
The MedDRA code search/browse tool enables the drag-and-drop addition of code lookups to any Pega 7.3 application.
LS product browse This feature provides the new product browse support for Pega 7.3 applications. This lookup is equipped to browse the internal products data structure or WHO Drug Dictionary (WHO DD). This is again a drag-and-drop addition of product lookup to any Pega 7.3 application.
LS auditable notifications This feature enables electronic access to Pega 7.3 applications for groups of external process participants such as Investigators, Subjects, Regulators, IRBs, and other individuals and organizations. In life sciences, workflows from clinical (investigator and subject enrollment) to sales and marketing (samples management and grants processing), organizations need to include external participants in regulated workflows.
The auditable distribution accelerator enables audited access to external users and includes auditable email distribution, one-time-password generation, and external user data capture for Pega 7.3 applications.
Pega Foundation for Life Sciences - Product Overview 4
This topic describes the business use cases for the Pega Foundation for Life Sciences features.
LS field auditing — FDA Part 11 accelerator
LS reports — PDF eForm accelerator LS MedDRA codes — MedDRA code browser
LS product browse — Search from internal products table or WHO DD
LS auditable notifications — Auditable distribution accelerator
Use case 1: LS field auditing The FDA under FDA 21 CFR Part 11 requires that changes made to data values on an official electronic record be auditable. This means that the user making the change must be authenticated at the time of the change, and the date, values, and reason the change was made must be recorded, saved, and preserved in an audit history.
The Pega Foundation for Life Sciences application includes the FDA 21 CFR Part 11 Audit Trail Accelerator, which enables the Auditing by adding audit Activity Rules to capture auditable events, modifying Flow Action Rules to include audit controls, and managing the integrated Part 11 audit log. The Part 11 Audit Trail Accelerator provides these capabilities through an easy-to-use interface that minimizes the individual customization of Pega 7.3 applications.
What the Audit Trail Accelerator does The Audit Trail Accelerator allows you to enable Part 11 auditing for the flow actions used by a work type.
How auditing affects the user interface and processing The following examples show how field auditing works when an online user modifies an audited field on a flow action of an existing audit record and how Pega Foundation for Life Sciences maintains an audit history and log of the change.
When a flow action configured for auditing is displayed, a View Audit History button appears. This button will show the detailed current audit history at any time. Audit events generated can also be viewed in the Pega 7.3 provided audit trail.
The audit history only shows audit events that have been successfully applied. This means that audit events on the current screen will not be displayed.
Business use cases
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You must confirm the changes and successfully advance to the next screen to complete the audit event before any new changes appear in the audit log.
Click Next to change the content of one or more audited fields. In this example, the Investigator Name has been overwritten.
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The system detects that a change has been made to an audited field. An error message appears that indicates an auditable record has been modified and instructs the user to confirm and authenticate the change. Until that process is satisfied, the work cannot resume.
Click Review and Confirm Audited Modifications; the Audit Dialog window appears where the modified field is displayed, showing the old and new values. If more than one field has been modified, a list is displayed.
You must enter a reason for each modification, along with your operator ID and password to continue. After you have entered these details in the Audit Dialog window, click Next on the main flow to continue.
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After clicking OK, the update is complete and data is confirmed, and an entry is made to the Audit History of the action. Click Next to continue.
Clicking View Audit History in the next section displays the newly added audit history. The audit history shows each audit event as a line item. Expanding the Modifications section displays each field-level reason and property value for a line item in the history.
Audit information is also available in a standard Pega 7.3 audit log format.
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Additional options for field auditing Disable the Electronic Signature while confirming changes to properties
Enable submit changes without entering Reason for Change
Bypass the Confirmation dialog
Show/Hide the audit buttons
You can enable and configure these features using the LSFieldAuditSettings Map Value rule.
Use case 2: LS reports Many life sciences processes require the generation of PDF-based forms and reports. Pega 7.3 provides some PDF eForm capabilities, but these features require technical expertise for the creation of eForm activity rules. Business users need a tool that provides the ability to map object data from a Pega 7.3 application into a PDF eForm and generate it as a selection action in a work process. The form should be created with interactive form fields by a form tool such as Adobe Acrobat Pro (V7+).
PDF eForms created with XML-based PDF form tools such as Adobe LiveCycle Designer are not supported by this feature.
The tool is able to update existing maps for existing forms as well as create new form mapping.
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What the feature does This feature uses the PDF eForm Mapping Accelerator to map properties into sections of a new or existing PDF eForm and create an activity that can be called to map the data from a work object into the form and generate the PDF output.
Use case 3: LS MedDRA codes The use of MedDRA is a common requirement for safety and pharmacovigilance applications. For example, AEs must be coded with MedDRA for submission to the FDA.
What the feature does This feature provides a working sample of how the MedDRA code search/browse tool allows users to configure capabilities that can be used to implement the following:
Drag and drop support for MedDRA lookups performed by a process or control
Auto-lookup for ICD & WHOART matching
Dynamic browsing capabilities with multiple select options and contextual help
Browsing terms and codes 1. Click Browse Codes to open the MedDRA browse window. It opens to the Select from the
directory option, where users can browse codes by navigating down from the System Organ Class through the sub-levels.
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2. Select as many Preferred Terms and/or Low Level Terms as needed. Click the Review tab within the MedDRA dialog to see the selected codes.
Hovering over selected codes will show other corresponding codes—where available—for WHOART, ICD 9/10, and other coding dictionaries.
Searching for terms and codes 1. When viewing the MedDRA dialog, clicking the Search for Terms/Codes option switches the
display from browse to search mode.
2. Enter the search criteria using the various search settings that are available to narrow or expand the search. Long result lists are paginated.
a. Like the browse option, select the codes and click the Review tab to see the list of selected codes.
In Search mode, you can hover over the MedDRA terms and see their relative location in the MedDRA tree that displays in a pop-up window.
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Use case 4: LS product browse Browsing a list of medicinal products is a very common use case in almost all pharma applications, for example, choosing the suspect products in AE reporting.
What the feature does This feature enables you to browse products from a site-specific product data structure or from the external WHO DD table.
Browsing products You have an option to either browse the internal product tables (My Product Tables) or the WHO drug dictionary or Add new product.
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There are two layouts below: Search criteria and Search results. After you enter the criteria and click Search, the search results are shown in a repeat grid layout below.
The selected product details will be populated to the parent page context shown below:
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Similarly, when you choose to search a product from the WHO DD table, the respective search criteria and results are shown. The rest of the behavior remains the same. When results are displayed from the WHO DD, an expand pane option is provided in order to see more details about the product, such as ATC Codes and Active Ingredients.
The Add new product option lets you add a new product to the internal products repository.
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Use case 5: Pega Foundation for Life Sciences auditable notifications Many life sciences processes involve groups of external participants. Pega 7.3 provides a Directed Web Access feature that enables some of these features but requires technical skills to include and track these types of processes within applications. Users of Pega 7.3 applications want to enable the creation and audit of distribution lists for sponsor/CRO to Investigator/Subject workflows, such as:
Investigator enrollment
Subject enrollment
Protocol distribution and updates
Informed consent
Safety reporting
This capability also includes the ability to
Generate auditable one-time access links to retrieve reports or complete forms
Create auto-generated passwords to support compliance workflows
Extend it so it can be used for two-factor authentication
Capture and maintain complete audit trails that identify individual responses and their current status
What the feature does This feature uses the auditable distribution accelerator to send forms or information to a list of external participants and authenticates those participants using a one-time password. This enables the tracking of content distribution or forms at the individual user level, helping demonstrate compliance at a much greater level than simple one-way email alone.
Auditable distributions can be used in any Pega 7.3 work object and are configured from the LS auditable notifications landing page. The configuration process generates an auditable distribution activity that can be referenced as needed in the implementation-specific flows.
