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Administrator Guide

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

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Navigate To: Administration - Organization units

Available Actions:

  • Add root unit

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Navigate To: Administration - Organization units - Add Root Unit
  • Edit

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

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

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

image-20220802-144013.png
Navigate To: Administration - Organization units - Select Organization Tree - Delete

Roles

image-20220802-144035.png
Navigate To: Administration - Roles


Available Actions:

  • Create New Role

    • Role properties:

      • Role name

      • On/Off: Assign new users by default

    • Permissions

image-20220802-144100.png
Navigate To: Roles - Create New Role


  • Edit

    • Edit role properties:

      • Edit role name

      • On/Off: Assign new users by default

    • Permissions

image-20220802-144119.png
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.

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Navigate To: Roles - Create New Role - Permissions Tab


Users

image-20220802-144211.png
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
image-20220802-144236.png
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

image-20220802-144304.png
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.

image-20220802-144329.png
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:


image-20220802-144407.png
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


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Navigate To: Administration - Change logs

Available Actions:

  • Search

  • Filter

    • Date Range

    • From Value

    • To Value

    • Username

    • Action

    • Entity Type

    • Field Name

  • Export to Excel

  • Refresh

Settings:

General:

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Navigate To: Administration - Settings - General


Available Settings:

Timezone:

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

Match Settings:

image-20220802-144644.png
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

image-20220802-144712.png
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

image-20220802-144733.png
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:

image-20220802-144757.png
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.

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.

NCA Settings

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

image-20220802-144823.png
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.

Manage Systems

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Navigate To: Administration - Manage Systems


Available Settings:

  • Create New System

    • Name system

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Navigate To: Administration - Manage Systems - Create New System
  • Edit System

    • Edit system name

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Navigate To: Administration - Manage Systems - Cog Icon - Edit
  • Delete System

    • Confirm the deletion action by clicking Yes

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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


image-20220802-145017.png
Navigate To: Administration - Tags


Available Settings:

  • Create new Tag

    • Name

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Navigate to: Administration - Tags- Create New Tag
  • Edit Tag

    • Name

image-20220802-145113.png
Navigate To: Administration - Tags - Cog Icon - Edit
  • Delete Tag

    • Confirm the deletion action by clicking Yes.

image-20220802-145204.png
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

image-20220802-145228.png
Navigate To: Administration - Resolution Status


Available Settings:

  • Create Status

    • Name

    • Colour

    • Icon

    • On/Off: Maintain mapping record

  • Edit

  • Delete

image-20220802-145252.png
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.

image-20220802-145315.png
Navigate To: Administration - Reasons


Available Actions:

  • Create New Reason

    • Reason

    • On/Off: Default

    • On/Off: Active

image-20220802-145342.png
Navigate To: Administration - Reasons - Create New Reason
  • Edit

image-20220802-145414.png
Navigate To: Administration - Reasons - Cog Icon - Edit
  • Delete

image-20220802-145435.png
Navigate To: Administration - Reasons - Cog Icon - Delete

Data Governance

Settings

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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

image-20220802-145539.png
Navigate To: Administration - Data Governance - Governance Status

Available Actions:

  • Create New Status

    • Name

    • Colour

    • Icon

    • Publish

    • Active

image-20220802-145606.png
Navigate To: Administration - Data Governance - Governance Status - Create New Status
  • Edit (Static Status)

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Navigate To: Administration - Data Governance - Governance Status - Cog Icon - Edit
  • Edit (User Defined Status)

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

Note: Only user defined statuses can be deleted.

image-20220802-145711.png
Navigate To: Administration - Data Governance - Governance Status - Cog Icon - Delete

Veeva Integration


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Navigate To: Administration - Integrations
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Navigate To: Administration - Integrations - Configure

Prerequisites

In order to use SPORIFY’S Veeva Vault RIM integration, it is neccessary to have access to the following Veeva Vault RIM objects and fields.

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

SPORIFY Mapping


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

SPORIFY Mapping


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

SPORIFY Mapping


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.

Create the following permissions set:

  • API

  • All API

  • Access API

  • Events API

  • Metadata API

  • File Staging

  • Access

  • Vault Owner Actions

  • Vault Loader

image-20220802-150803.png
Permissions

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

image-20220802-150832.png
Security Profile

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

image-20220802-150856.png
User Profile

Settings

Available Actions:

  • Connect to Veeva

    • Vault Subdomain

    • Username and Password

      • Username

      • Password

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Navigate To: Administration - Integrations - Configure - Connect to Veeva - User Name and Password
  • Run Manual Sync

    • Full Sync

    • Referentials Only

    • Organisations Only

    • Substances Only

image-20220802-150944.png
Navigate To: Administration - Integrations - Configure - Manual Sync
  • Add New List Mapping

    • Veeva List

    • List Type

    • Mapping Target

    • Active

image-20220802-151003.png
Navigate To: Administration - Integrations - Configure - Mapping Configuration - New List Mapping
  • Edit

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

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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

image-20220802-151100.png
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

image-20220802-151116.png
Navigate To: Administration - Integrations - Configure - Scheduled Sync
  • View Job Log

image-20220802-151131.png
Navigate To: Administration - Integrations - Configure - Job Log
  • Export to Excel

  • Filter

    • Date Range