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Administrator Guide

Get certified by completing our SPORIFY Users Training course which is available via the CorrIT Training Academy. Contact your local SPORIFY administrator for more information.

General Information

System Overview

The features of the system include:

Functions

  • Provide system and user administration to tenants.

  • Match preformatted Excel or CSV lists to SPOR Master Data Management Services and G-SRS controlled substance lists.

  • Provide the ability to create and set a Resolution Status to each term on your uploaded list.

  • Provide the ability to create and apply Data Tags to your Source or Target Data.

  • Export each list you have uploaded along with the set Resolution Status and any associated Mapping Data from RMS, OMS or G-SRS, as applicable to your list.

  • Provide an overview of your activity and Mapping Status via chart-based reports. These reports are known inside SPORIFY as Dashboard, Overview and Data Insight pages.

  • Provide an overview of the information available in SPOR RMS & OMS and G-SRS services.

  • Provide notifications to highlight when SPOR information is updated.

Note: Features available are dependent on the subscription plan you have licensed. Not all features are available for all subscription plans.

Browser Compatibility Settings

General Settings

  • SPORIFY makes use of modern web technology. To experience the system at its best we recommend a modern web browser listed below:

Browser

Supported Version

Chrome

Latest

Firefox

Latest

Edge

Latest

Internet Explorer

11.70 +

  • The system has been tested successfully in Internet Explorer 11.70. However, it is not recommended to run the system in older versions of Internet Explorer due to possible compatibility issues with the angular framework technology used by the system.

Administration Guide

Organization units

Navigate To: Administration - Organization units

Available Actions:

  • Add root unit

Navigate To: Administration - Organization units - Add Root Unit

  • Edit

Navigate To: Administration - Organization units - Select Organization Tree - Edit

  • Add sub unit

Navigate To: Administration - Organization units - Select Organization Tree - Add sub unit

  • Add member

Navigate To: Administration - Organization units - Select Organization Tree - Add member

  • Delete

Navigate To: Administration - Organization units - Select Organization Tree - Delete

Roles

Navigate To: Administration - Roles

Available Actions:

  • Create New Role

    • Role properties:

      • Role name

      • On/Off: Assign new users by default

    • Permissions

Navigate To: Roles - Create New Role

  • Edit

    • Edit role properties:

      • Edit role name

      • On/Off: Assign new users by default

    • Permissions

Navigate To: Roles - Actions - Edit Role

Assigning Permissions to a Role:

Select permissions from the tree view and save them to apply them to the created role.

Navigate To: Roles - Create New Role - Permissions Tab

Users

Navigate To: Administration - Users

Available Actions:

  • Create new user

  • Edit user

  • Assign roles

  • Assign permissions

  • Unlock

  • Delete

  • Login as this user

Note: This feature is helpful when troubleshooting user queries or working on another user's behalf. All actions carried out while an administrator is logged into another managed user account are clearly labelled in the audit log: “This operation is performed by another user on behalf of this user.”

Create New User

Navigate To: Administration - Users - Create New User

Available Settings:

  • Name

  • Surname

  • Email address

  • Phone number

  • Username

  • Profile picture

  • Security Settings:

    1. Set random password

    2. Should change password on next login

    3. Send activation email

    4. Account status (active)

    5. Is lockout enabled?

  • Assign Roles:

    1. Select from available roles

Edit New User

Navigate To: Administration - Users - Actions Button - Edit

Available Settings:

  • Name

  • Surname

  • Email address

  • Phone number

  • Username

  • Profile picture

  • Security Settings:

    1. Set random password

    2. Set new password

    3. Should change password on next login

    4. Send activation email

    5. Account status (active)

    6. Is lockout enabled?

  • Assign Roles:

    1. Select from available roles

Assign Permissions

Users can be assigned permissions outside of their provided roles if required.

Note: For a more efficient way to administer user permissions, please review the Roles section of this document. Roles allow permissions to be applied to users in groups to ease the administration overhead.

Navigate To: Administration - Users - Actions Button - Permissions

Available Top-Level Permissions:

  • Pages: Root level, required for SPORIFY Access

  • Access Control: Controls visibility of user data to other users within your tenant (RMS, OMS and SMS lists uploaded by this user will be shared with all users, but if disabled user data is private to their account)

  • Administration: Provides administration features to the user

  • Organisations: Permissions in the SPORIFY Organisations area

  • Referentials: Permissions in the SPORIFY Referentials area

  • Substances: Permissions in the SPORIFY Substances area

  • Dashboard: SPORIFY main dashboard and navigation bar

Audit Logs

Navigate To: Administration - Audit Logs

Description

  • Audit Logs can be filtered based on available criteria.

  • Audit logs can be exported to Excel.

  • Audit Logs show an error state:

    1. Success

    2. Has Error

  • Information about each entry can be found by clicking the detail button on the left of the table.

  • SPORIFY support staff may request a copy of the Audit Logs when troubleshooting.

Change logs

Navigate To: Administration - Change logs

Available Actions:

  • Search

  • Filter

    • Date Range

    • From Value

    • To Value

    • Username

    • Action

    • Entity Type

    • Entity ID

    • Field Name

  • Export to Excel

  • Refresh

Authentication logs

Navigate to Administration - Authentication logs

Available Actions:

  • Search

  • Filter

    • Date Range

    • From Value

    • Result

    • User Name

    • Browser

    • IP Address

  • Export to Excel

  • Refresh

Settings

General

Navigate To: Administration - Settings - General

Available Settings:

Timezone:

  • Choose your required timezone from the drop-down menu.

Match Settings

Navigate To: Administration - Settings - Match Settings

Available Settings:

Matching Preferences (Fuzzy Matching):

  • On/Off: Ignore punctuation and common abbreviations while matching source to Target data.

    • If you enable this, the following punctuation, special characters and character spacing will be ignored while matching your data: < > | # ~ - * . , ? ! ; : ( ) [ ] { } & ^ ' "

    • SPORIFY will also include common abbreviations in the matching algorithm, e.g. Ltd = Limited.

  • On/Off: Automatically match Source Data to Target Data when the system preforms a sync.

    • If you disable this, your local data will not be kept in sync with SPOR.

System To System Preferences:

  • On/Off: Apply manual matches found in any source system when uploading new lists to the same target.

    • If you disable this, system defaults will apply. If you enable this, any manual matches previously applied to terms in other system lists will be applied to new lists where the source terms are equal.

  • On/Off: Apply the Resolution Status found in any source system when uploading new lists to the same target.

    • If you disable this, system defaults will apply. If you enable this, any Resolution Status applied to terms in other system lists will be applied to new lists where the source terms are equal.

  • On/Off: Apply matches based on identical source IDs on the same list.

    • If you disable this, system defaults will apply. If you enable this, source records will automatically match if they share Id with a matched record.

Warning: Match Settings can increase or decrease the accuracy of system default matching. Please test results with sample data before applying these settings to a production environment.

Auto Follow Favourites:

  • On/Off: If you disable this, system defaults will apply. If you enable this, any OMS organisation you are matched to will be added to your favourites automatically.

EMA Settings

Navigate To: Administration - Settings - EMA Settings

Available Settings:

  • EMA Credentials (User Name and Password)

    • Credentials are required for EMA SPOR API access on behalf of your organisation.

    • One EMA credential is required per tenant account.

    • Enter credentials and click Test to confirm that the account has API access.

    • To remove your EMA credentials from SPORIFY, select Clear and Save.

User Management

Navigate To: Administration - Settings - User Management

Available Settings:

Form Based Registration

  • On/Off: Allow users to register to the system.

    • If disabled, users can only be created by a tenant admin account using the user management page.

  • On/Off: Set auto-activate preference.

    • If you disable this, new users will not be active (and cannot login) until admin manually activate the account.

  • On/Off: Require Captcha security question.

  • On/Off: Email confirmation required for login of new users.

Security

Navigate To: Administration - Settings - Security

Available Settings:

Password complexity

  • On/Off: Use default settings.

    1. If Off is selected, on-screen default settings will be applied.

  • Set minimum password length.

  • Set maximum password length.

  • Complexity requirements:

    1. On/Off: Use numbers in password.

    2. On/Off: Use upper case letters in password.

    3. On/Off: Use lower case letters in password.

    4. On/Off: Use punctuation marks in password.

Enforce Password History

  • On/Off: Limit Password Reuse.

    • Set maximum number of unique passwords before an old password can be reused.

Password Expiration

  • On/Off: Enable Password Expiration.

    • Set maximum number of days before users have to renew password.

User Lock Out

  • On/Off: Enable user lockout after failed login attempts.

    • Set maximum number of failed attempts before locking the account.

  • On/Off: Account is locked until administrator unlocks it.

Two Factor Login

  • On/Off: Enable two factor user login.

    • Users will receive an authentication code to their registered email address.

  • On/Off: Allow to remember browser.

    • If you allow this, users can select to remember the browser so that they do not have to do the two factor login twice on the same browser.

IP Whitelisting

  • Add trusted IP addresses or IP ranges from which your users can access your tenant account.

    • Add one entry per line in the format x.x.x.x for a single address or x.x.x.x/y for a range of addresses.

Session Idle Timeout

  • On/Off: Automatically Log Out User After A Set Period Of Inactivity.

    • Set maximum number of seconds before logging out the user.

NCA Settings

Note: NCA Settings are only available with the NCA edition of SPORIFY.

Navigate To: Administration - Settings - NCA Settings

Available Settings:

Translation Settings

  • Default translation status

    • Choose appropriate status from the drop-down menu.

  • Translation Languages

    • Choose appropriate language from the drop-down menu.

External Login Settings

With External Login Settings, it´s possible to include user accounts hosted on an external identity provider. SPORIFY supports OpenID Connect 1.0 with Okta, Microsoft Azure AD, OneLogin, and ForgeRock as identity provider.

Navigate To: Administration - Settings - External Login Settings - OpenId with Okta

Navigate To: Administration - Settings - External Login Settings - OpenId with Azure Active Directory

Navigate To: Administration - Settings - External Login Settings - OpenId with OneLogin

Navigate To: Administration - Settings - External Login Settings - OpenId with ForgeRock

Available Settings:

  • OpenID with Okta

    • Authority

    • Client ID

    • Client Secret

    • Redirect URL

  • OpenID with Azure Active Directory

    • Authority

    • Client ID

    • Client Secret

  • OpenID with OneLogin

    • Authority

    • Client ID

    • Client Secret

  • OpenID with ForgeRock

    • Authority

    • Client ID

    • Client Secret

    • Redirect URL

Obtaining OpenID With Okta Credentials:
  • Login to Okta.

  • Select Applications on the navigation menu.

  • Select Applications.

  • Click the Create App Integration button.

  • Select the following options:

    • Sign-in method

      • OIDC - OpenID Connect

    • Application type

      • Web Application

  • Click the Next button.

  • Complete the following fields:

    • General Settings

      • App integration name

      • Grant type

        • Select Authorization Code and Implicit (hybrid)

  • Assignments

    • Controlled access

      • Select the relevant option.

    • Enable immediate access

      • Check the ‘Enable immediate access with Federation Broker Mode’ checkbox.

  • Click the Save button.

  • View the information provided about the created app, including Client ID and Client Secret.

  • Select Security on the navigation menu.

  • View the relevant Issuer URI, which is the required Authority code.

  • Once the credentials have been obtained:

    • Login to SPORIFY.

    • Click Administration on the navigation menu.

    • Click Settings.

    • Select External Login Settings.

    • Check the OpenID with Okta checkbox.

    • Complete the presented fields.

    • Click Save All.

Navigate To: Administration - Settings - External Login Settings - OpenId with Okta

Obtaining OpenID With Azure Active Directory Credentials:
  • Login to aad.portal.azure.com.

  • Select Azure Active Directory.

  • Select App Registrations on the navigation menu.

  • Click New Registration.

  • Name the application using the Name field.

  • Select the supported account type ‘Accounts in any organizational directory (Any Azure ID directory - Multitenant).

  • Under Implicit Grant And Hybrid Flows, select ‘ID tokens (used for implicit and hybrid flows)’.

  • Click Save.

  • Navigate to Certificates & Secrets.

  • Click New Client Secret.

  • Provide a description in the Description field.

  • Set an expiry date using the Expires field.

  • View the Client Secret that has been created.

  • Copy and save the Secret ID.

  • Navigate to the Overview tab to view and copy the Client ID.

  • Select Token Configuration on the navigation menu.

  • Click Add Optional Claim.

  • Under Token Type, select ID.

  • Select the following claims: email and given_name.

  • Click Add.

  • Check the ‘Turn on the Microsoft Graph email, profile permission…’ checkbox.

  • Click Add.

  • Click Add Optional Claim again.

  • Under Token Type, select Access.

  • Check email and given_name.

  • Click Add.

  • Once the credentials have been obtained:

    • Login to SPORIFY.

    • Click Administration on the navigation menu.

    • Click Settings.

    • Select External Login Settings.

    • Check the OpenID with Azure Active Directory checkbox.

    • Complete the presented fields.

    • Click Save All.

Navigate To: Administration - Settings - External Login Settings - OpenId with Azure Active Directory

Logging In To SPORIFY Using SSO:
  • Insert the relevant credentials.

  • Click the Single Sign On button.

    • The user is redirected to Okta/Azure/OneLogin.

Navigate To: Login

  • Login via Okta/Azure/OneLogin.

    • If the user has already signed up, they are redirected to SPORIFY.

    • If the user has not already signed up, they are redirected to the SPORIFY Sign Up screen.

  • To sign up, fill in the following fields:

    • Tenant

    • First name

    • Surname

    • Email

  • Click the Submit button.

    • A confirmation email is sent to the user. Via this email, the user is required to confirm their email address.

    • The user must then wait for their account to be activated by system admin.

Manage Systems

Navigate To: Administration - Manage Systems

Available Settings:

  • Create New System

    • Name system

Navigate To: Administration - Manage Systems - Create New System

  • Edit System

    • Edit system name

Navigate To: Administration - Manage Systems - Cog Icon - Edit

  • Delete System

    • Confirm the deletion action by clicking Yes

Navigate To: Administration - Manage Systems - Cog Icon - Delete

Note: Deleting a Resolution Status will revert the status of all records in the system that the deleted Resolution Status was applied to back to their default status set by SPORIFY after matching, e.g. “Matched”, “Not Set” or “Suggested” as applicable.

Tags

Navigate To: Administration - Tags

Available Settings:

  • Create new Tag

    • Name

Navigate to: Administration - Tags- Create New Tag

  • Edit Tag

    • Name

Navigate To: Administration - Tags - Cog Icon - Edit

  • Delete Tag

    • Confirm the deletion action by clicking Yes.

Navigate To: Administration - Tags - Cog Icon - Delete

Note: Deleting a Tag will remove the Tag from any data that it has been associated with. The system will ask if you are sure you wish to proceed with the delete action. A summary of the number of records the Tag will be removed from will be displayed for your information. You must confirm if you wish to proceed or cancel.

Resolution Status

Navigate To: Administration - Resolution Status

Available Settings:

  • Create Status

    • Name

    • Colour

    • Icon

    • On/Off: Maintain mapping record

  • Edit

  • Delete

Navigate To: Administration - Resolution Status - Create New Status

Note: Deleting a Resolution Status will revert the status of all records in the system that the deleted Resolution Status was applied to back to their default status set by SPORIFY after matching, e.g. “Matched”, “Not Set” or “Suggested” as applicable.

Change Reasons

Change Reasons are utilised as part of e-signature which is an optional setting under Data Governance for each data domain. When completing e-signature, a reasons dropdown is available where approvers can choose from this pre-defined reason list.

Note: By default, no reasons will be automatically created. SPORIFY administrators must create reasons suitable for their internal process.

Navigate To: Administration - Reasons

Available Actions:

  • Create New Reason

    • Reason

    • On/Off: Default

    • On/Off: Active

Navigate To: Administration - Reasons - Create New Reason

  • Edit

Navigate To: Administration - Reasons - Cog Icon - Edit

  • Delete

Navigate To: Administration - Reasons - Cog Icon - Delete

Data Governance

Settings

Navigate To: Administration - Data Governance - Settings

Available Settings:

  • Substances

    • On/Off: Governance Required

    • Assign Reviewers

    • Assign Approvers

    • On/Off: 4 Eye Principal

    • On/Off: Enable Governance Where Record Matched

    • On/Off: E-Signature

  • Organisations

    • On/Off: Governance Required

    • Assign Reviewers

    • Assign Approvers

    • On/Off: 4 Eye Principal

    • On/Off: Enable Governance Where Record Matched

    • On/Off: E-Signature

  • Referentials

    • On/Off: Governance Required

    • Assign Reviewers

    • Assign Approvers

    • On/Off: 4 Eye Principal

    • On/Off: Enable Governance Where Record Matched

    • On/Off: E-Signature

Governance Status

Navigate To: Administration - Data Governance - Governance Status

Available Actions:

  • Create New Status

    • Name

    • Colour

    • Icon

    • Publish

    • Active

Navigate To: Administration - Data Governance - Governance Status - Create New Status

  • Edit (Static Status)

Navigate To: Administration - Data Governance - Governance Status - Cog Icon - Edit

  • Edit (User Defined Status)

Navigate To: Navigate To: Administration - Data Governance - Governance Status - Cog Icon - Edit

  • Delete

Note: Only user defined statuses can be deleted.

Navigate To: Administration - Data Governance - Governance Status - Cog Icon - Delete

Veeva Integration

SPORIFY’s optional Veeva Integration connects SPORIFY directly with Veeva Vault RIM and synchronises Controlled Vocabularies and Organisation and Substance records with SPORIFY, where you can manage your SPOR data with Data Governance and Data Flow Control.

Navigate To: Administration - Integrations

Navigate To: Administration - Integrations - Configure

Prerequisites

We recommend the use of a service account for SPORIFY to access Veeva Vault RIM. In order to use SPORIFY’S Veeva Vault RIM integration, it is necessary to have access to the following Veeva Vault RIM objects and fields, all of which are required by the SPORIFY service account.

Access is required to the following Veeva Vault RIM objects:

Vault RIM Object Name

drug_substance_v

excipient__v

organization__rim

country__v

language__rim

controlled_vocabulary__rim

The following fields must be available for import:

Vault RIM Object Name

Vault RIM Field Name

controlled_vocabulary__rim

id

name__v

country__v

id

name__v

language__rim

id

name__v

organization__rim

id

name__v

address__rim

city__rim

state__rim

postcode__rim

country__rim.name__v

drug_substance__v

id

name__v

ev_code__v

spor_substance_code__v

us_substance_code__v

eudamed_inn__v

cas_number__v

excipient__v

id

name__v

ev_code__v

spor_substance_code__v

us_substance_code__v

The following fields must be available for export:

Vault RIM Object Name

Vault RIM Field Name

SPORIFY Mapped Data

controlled_vocabulary__rim

Vault RIM fieldname

SPORIFY Mapping

id

N/A

spor_list_id__v,

RMS List ID

spor_list_name__v

RMS List Name

spor_rms_id__v

RMS Term ID

spor_term__v

RMS Term Name

spor_status__v

RMS Term Status

spor_domain__v

RMS Term Domain

spor_version__v

RMS Term Version

country__v

Vault RIM fieldname

SPORIFY Mapping

id

N/A

spor_list_id__v,

RMS List ID

spor_list_name__v

RMS List Name

spor_rms_id__v

RMS Term ID

spor_term__v

RMS Term Name

spor_status__v

RMS Term Status

spor_domain__v

RMS Term Domain

spor_version__v

RMS Term Version

language__rim

Vault RIM fieldname

SPORIFY Mapping

id

N/A

spor_list_id__v,

RMS List ID

spor_list_name__v

RMS List Name

spor_rms_id__v

RMS Term ID

spor_term__v

RMS Term Name

spor_status__v

RMS Term Status

spor_domain__v

RMS Term Domain

spor_version__v

RMS Term Version

organization__rim

Vault RIM fieldname

SPORIFY Mapping

id

N/A

spor_oms_id__v

SPOR OMS ID

spor_location_id__v

SPOR LOC ID

location_status__v

SPOR LOC Status

drug_substance__v

Vault RIM fieldname

SPORIFY Mapping

id

N/A

ev_code__v

ev code (XEVMPD)

spor_substance_code__v

EUTCT ID

us_substance_code__v

G-SRS UNII

spor_term__v

EUTCT Substance Name

excipient__v

Vault RIM fieldname

SPORIFY Mapping

id

N/A

ev_code__v

ev code (XEVMPD)

spor_substance_code__v

EUTCT ID

us_substance_code__v

G-SRS UNII

spor_term__v

EUTCT Substance Name

Account Permissions

The following account permissions are advised to provide least privilege to the service account used to connect to your Vault RIM tenant.

Permissions Set - Details:

  • Status: Active

  • Name: SPORIFYIntegration

  • Description: Permission set used for SPORIFY sync via Loader API

  • Created By: [Name]

  • Created Date: [Date]

  • Last Modified By: [Name]

  • Last Modified Date: [Date]

Details

Permissions Set - Application:

API Permissions:

  • All API

  • Access API

  • Events API

  • Metadata API

File Staging Permissions:

  • Access

Vault Owner Actions Permissions:

  • Vault Loader

Application

Permissions Set - Objects:

Read, Create & Edit Permissions:

  • Base Active Substance

  • Specified Active Substance

  • Active Substance

  • Ingredient

  • Controlled Vocabulary

  • Country

  • Language

  • Organization

Objects - Read, Create & Edit

Read Only Permissions:

  • Base Envelope

  • All Envelope

  • Base Envelope Content

  • Document (Specific Version)

  • Document (Latest Version)

  • Object Content

  • RIM View

  • User

Objects - Read

Profile Setup:

  • Create a security profile to use the earlier created permissions set.

Security Profile

  • Create a user profile attached to the earlier created security profile.

User Profile

Settings

Available Actions:

  • Connect to Veeva

    • Vault Subdomain

    • Username and Password

      • Username

      • Password

Navigate To: Administration - Integrations - Configure - Connect to Veeva - User Name and Password

  • Run Manual Sync

    • Full Sync

    • Referentials Only

    • Organisations Only

    • Substances Only

Navigate To: Administration - Integrations - Configure - Manual Sync

  • Add New List Mapping

    • Veeva List

    • List Type

    • Mapping Target

    • Active

Navigate To: Administration - Integrations - Configure - Mapping Configuration - New List Mapping

  • Edit

Navigate To: Administration - Integrations - Configure - Mapping Configuration - Cog Icon - Edit

  • Delete

Navigate To: Administration - Integrations - Configure - Mapping Configuration - Cog Icon - Delete

  • Set Sync Configuration Settings

    • Mapped Record Options

      • On/Off: Limit Mapped Data By Resolution Status

      • On/Off: Limit Target Data By Governance Status

    • Unmatched Record Options

      • On/Off: Limit Unmatched Data Included In Sync By Resolution Status

    • Advanced Vault Loader Options

      • controlled_vocabulary_rim

      • country_v

      • drug_substance_v

      • excipient_v

      • language_rim

      • organization_rim

Navigate To: Administration - Integrations - Configure - Sync Configuration

  • Set Scheduled Sync

    • Enable/Disable

    • Schedule Type

      • Hourly

        • Every X hour(s)

        • Starts at [HH:MM]

      • Daily

        • Everyday

        • Every weekday

        • Starts at [HH:MM]

      • Weekly

        • Week Days

        • Starts at [HH:MM]

      • Monthly

        • Day X of every Y months

        • The [Number] [Day] of every [Number] months(s)

        • Starts at [HH:MM]

    • Timezone

Navigate To: Administration - Integrations - Configure - Scheduled Sync

  • View Job Log

Navigate To: Administration - Integrations - Configure - Job Log

  • Export to Excel

  • Filter

    • Date Range

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