EDQM Webinar - Introduction To OMS

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Introduction to Organisation Management Service (OMS)

11 & 16 May 2023

EDQM Webinar

An agency of the European Union


OMS Introduction - Key Principles (1/4)
OMS Dictionary provides a central source of organisation data
hosted by EMA, accessible to and used throughout EMA and by
external stakeholders

An organisation, as a legal entity, groups all its


physical locations within a country
Roles (MAH vs Manufacture), context (H vs V) and details
of Departments are not managed in OMS

1 Introduction to Organisation Management Service (OMS)


Classified as public by the European Medicines Agency
OMS Introduction - Key Principles (2/4)
OMS Dictionary provides a central source of organisation data
hosted by EMA, accessible to and used throughout EMA and by
external stakeholders

An organisation, as a legal entity, groups all its


physical locations within a country
Roles (MAH vs Manufacture), context (H vs V) and details
of Departments are not managed in OMS

Organisation data structured with unique IDs


(Organisation_ID and Location_ID) and
mapped to records loaded from source systems
(e.g. EudraGMDP site reference code)

2 Introduction to Organisation Management Service (OMS)


Classified as public by the European Medicines Agency
OMS Introduction - Key Principles (3/4)
OMS Dictionary provides a central source of organisation data
hosted by EMA, accessible to and used throughout EMA and by
external stakeholders

An organisation, as a legal entity, groups all its


physical locations within a country
Roles (MAH vs Manufacture), context (H vs V) and details
of Departments are not managed in OMS

Organisation data structured with unique IDs


(Organisation_ID and Location_ID) and
The Location_ID will be unique and will not change
mapped to records loaded from source systems
(e.g. EudraGMDP site reference code)

OMS publish the latest information available and maintain all


versions in a date format (version timestamp)

3 Introduction to Organisation Management Service (OMS)


Classified as public by the European Medicines Agency
OMS Introduction - Key Principles (4/4)
OMS Dictionary provides a central source of organisation data
hosted by EMA, accessible to and used throughout EMA and by
external stakeholders

OMS does not have individuals. If individuals An organisation, as a legal entity, groups all its
are required in a certain regulatory procedure, physical locations within a country
this needs to be dealt directly by each system. Roles (MAH vs Manufacture), context (H vs V) and details
of Departments are not managed in OMS

Organisation data structured with unique IDs


(Organisation_ID and Location_ID) and
The Location_ID will be unique and will not change
mapped to records loaded from source systems
(e.g. EudraGMDP site reference code)

OMS publish the latest information available and maintain all


versions in a date format (version timestamp)

4 Introduction to Organisation Management Service (OMS)


Classified as public by the European Medicines Agency
Where to find OMS?

OMS portal
ServiceNow
- OMS Dictionary
- Questions (data or system
- Change Request functionality to related, follow-up on Change
update/addUpdate/add
organisation locations
organisation request)
to OMS Dictionary
locations to OMS Dictionary
- Report an Incident
- OMS guidance and requirements
OMS Web UI (europa.eu) Employee Topic - Employee Center (europa.eu)

5 Introduction to Organisation Management Service (OMS)


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Who can change OMS data?

Anyone can submit


Manufactures SPOR NCA/Industry a Change Request to
Super User any organisation
and/or location
published in the
OMS Dictionary, as
MAH, Sponsor long as they submit
NCA supporting
documentation*
Validation of data as per
SPOR NCA/Industry date of the Change Request
User

Hospitals, University

*Further information on requirements can be found on the OMS portal


6 Introduction to Organisation Management Service (OMS) under document E – Change request
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OMS Change Request process at a glance

Submission Validation/ Standardisation Approval/ Rejection

• 5-10 WD SLA

• CR Approved or
Rejected user always
receives email
acknowledgment with
EMA Data Guidance/ EMA Data Stewards
Requestor the outcome
Stewards references & tools EMA is OMS Data Owner
• If disagreement, raise
Submit OMS CR with Data Stewards validate all OMS CRs using guidance/ ticket in Service Desk,
supporting document references & tools (OMS DQ standard, Business indicating CR number
registry, AddressDoctor validation service)

Organisation data owner


EMA

7 Introduction to Organisation Management Service (OMS)


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Data vs Reference Sources

OMS is a standardised list of Organisations/Locations

OMS uses Reference OMS data reflects OMS reflects equivalent OMS reflects consistent
sources of information reality: information as the Trade information i.e. OMS
(Trade registry, DUNS, registry (or other will apply/standardise
• correct
other documents/sources) but the Organisation/address
organisation/legal
documents/sources) to it is not meant to be information according to
entity
ensure data the same/“copy” of the agreed DQ rules
correctness/accuracy • correct relationship Trade registry (or other
with its address documents/sources)
• correct address

8 Introduction to Organisation Management Service (OMS)


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Data & Data Management Process

Organisation name Location data

1. Business registry, Relationship Business registry,


Validation DUNS DUNS

If loc is not
2. OMS Data Quality National Postal
recognised by AD,
Standardisation Standards Service
data will follow OMS
(AddressDoctor)
DQ Standards

DQ Standards National Postal Service

9 Introduction to Organisation Management Service (OMS)


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What is AddressDoctor?

AddressDoctor is an address library used for address validation, correction and standardisation

World-wide & Certified Standardised Enriched

• AddressDoctor’s validation service is • Addresses are formatted according to • AddressDoctor’s validation


delivered in combination with local postal standards service allows to enrich
reference data for more than 240 address data with geocodes
countries and territories • Validation service can parse, analyse,
verify, correct and format addresses
• The service combines in one engine according to local postal standards -
postal certifications from all five ensuring that correct elements appear
global postal organisations in the appropriate hierarchical alignment

Character set & Up-to-date


transliteration
• Address Verification supports 40 different • The reference database is
character sets and transliterates updated throughout the
addresses into Latin characters from year
six different writing systems
• When available in the reference files
addresses can be automatically
transliterated – address localised will be
generated

10 Introduction to Organisation Management Service (OMS)


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OMS IDD - Change Request Process Organisation validation & standardisation

Validation

Standardisation

Midatech Limited

11 Introduction to Organisation Management Service (OMS)


Classified as public by the European Medicines Agency
OMS IDD - Change Request Process Location validation & standardisation

Validation

Standardisation

National Postal Service

12 Introduction to Organisation Management Service (OMS)


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Any questions on the webinar?

13
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Further information
Contact us through ServiceNow @ https://support.ema.europa.eu/

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands


Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

Follow us on @EMA_News

Classified as public by the European Medicines Agency

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