The IDMP Challenge - Whitepaper on ISO IDMP by Cunesoft

The IDMP Challenge
–
Preparing for Compliance with IDMP Requirements
March, 2018
Cunesoft GmbH, Luise-Ullrich-Strasse 20, 80636 Munich, Germany
Tel: +49-89-235 14 741
Cunesoft Inc., 103 Carnegie Center, Suite 300, Princeton, NJ 08540
Tel: +1 609-955-3468
Email: info@cunesoft.com

Cunesoft Whitepaper – The IDMP Challenge
© Copyright Cunesoft GmbH Page 2
Contents
1 IDMP: What is it and Why? ................................................................................................ 3
2 SPOR: What is it and Why?................................................................................................. 4
3 Legislative Status of IDMP.................................................................................................. 8
4 The Industry Challenge – Organizational Readiness for IDMP............................................. 9
5 Best Practices for IDMP readiness.................................................................................... 12
5.1 General Process Steps – How to eat an elephant?.......................................................... 12
5.2 Scope Analysis – Analyzing your data sources ................................................................ 12
5.3 Create a business plan .................................................................................................... 13
5.4 Using IDMP-savvy technology versus manual data entry................................................ 13
5.4.1 Mining your IDMP data from existing sources .......................................................... 14
5.4.2 IDMP data mapping with coding systems ................................................................. 15
5.4.3 IDMP data staging and curating................................................................................ 15
5.4.4 IDMP data maintenance and expected lifecycle........................................................ 15
6 IDMP solved via Regulatory Master Data Management.................................................... 16
6.1 Single Source of Truth..................................................................................................... 16
6.2 Benefits of solving IDMP via a Regulatory Master Data Management............................ 17
6.2.1 Reduce IDMP submission time ................................................................................. 17
6.2.2 Reduce IDMP preparation time to a minimum.......................................................... 17
6.2.3 Increase working speed from hours to minutes........................................................ 17
6.2.4 Reduce data maintenance costs by 70% ................................................................... 17
7 Summary and Conclusions ............................................................................................... 17

1 IDMP: What is it and Why?
IDMP stands for the Identification of Medicinal Products and is a general term used when
referencing the collection of ISO data standards – ISO 11615, ISO 11616, ISO 11238, ISO 11239
and ISO 11240 – that are being refined and implemented by regulatory bodies in support of
improving pharmacovigilance via the soon-to-be mandatory submission of this data to health
authorities.
In comparison to xEVMPD (Extended EudraVigilance Medicinal Product Dictionary), the current
legislative format, IDMP is substantially more detailed and complex.
By standardizing the structure and
terminology used to describe healthcare
products across all markets and all
marketing authorization holders (MAH), the
impact on health care delivery and patient
safety has great potential:
• Improved safety analytics across a
broader spectrum of information
• Globally identifiable product
information
• Complete product composition
information
• Enablement of information sharing
between stakeholders

2 SPOR: What is it and Why?
As described in chapter 1, IDMP represents five ISO standards. To ahieve these standards in future,
the European Medicines Agency (EMA) has launched an initiative to implement 4 of the 5 IDMP
standards. The project´s overall objective is to facilitate the reliable exchange of medicinal product
information in a robust and consistent manner.
Typically referred to as “SPOR”, the EMA describes the initiative as follows:
• Substance Management data (SMS), describing the ingredients of a medicine
• Product Management data (PMS), describing the marketing and medicinal information relating
to a product
• Organization Management data (OMS), providing the contact details of organizations and
individuals responsible for various aspects of a medicine
• Referential Management data (RMS), providing controlled vocabularies (e.g.
dosage, pharmaceutical forms, country codes, package codes, weight codes) for a medicine,
which are explicitly defined for use in Europe
In the first phase of the
implementation, the focus is
on RMS and OMS. They will
be the “data foundation” for
PMS and SMS. The specific
implementations continue
to evolve and are expected
to continue this refinement
incrementally after the
initial launch:
1. RMS and OMS (June
2017)
2. PMS and SMS will
follow (iterative)
SPOR currently applies to
the human and veterinary
domains.
Download here the Cunesoft SPOR fact sheet:https://cunesoft.com/wp-content/uploads/2017/12/SPOR-onepager.pdf
Using existing information, the OMS data migration will be done first by EMA. To refine this process,
additional functionality and bug fixes have been implemented to support data review and entry by

industry. More information on the implementation of SPOR data management services is available
on the EMA website.
The original SPOR timeline for implementation is described in the following graphic:
However, due to several recently identified risks, challenges and the move of the European
Medicines Agency from London to Amsterdam, the revised timeline is described here:
Source:
http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2018/01/WC500242388.pdf

As of today, the EMA website states that there will be a more detailed master data management
roadmap, which aligns with the approach to implementing the ISO IDMP standards. It is currently
being updated.
Key takeaways of the updated time line:
• 2018 Q1 milestone - messaging format agreement based on HL7 - expected to be
completed next taskforce meeting in March 2018
• 2018 Q1 milestone MAH data migration completed, other organization data to be
completed by EOY
• 2018 Q4 - RMS and OMS integrated with xEVMPD / Art 57 database
• 2018 Q4 - API's documentation for vendors are made available in draft
• 2018 Q4 - Guidance for industry, vendors and regulators are published
The EMA outlined the risks, related impacts and its mitigation activities as follows:
The SPOR portal provides users with the following data management services:
• view, search, export SPOR data;
• request new and updated SPOR data;
• translate SPOR data;
• browse relevant SPOR documentation.
Once these services are in place, stakeholders should start preparing to replace their current data
submission format, the extended EudraVigilance Product Report Message (XEVPRM), with the HL7
SPL format based on the ISO IDMP standards, ISO IDMP technical specifications and HL7 Common
Product Model.

This master data management (MDM) initiative will provide future services around master data and
enable the benefits to be realized through delivering value to stakeholders. Key goals for this project
include:
• Implementation of an integrated MDM solution which will deliver standards compliant
master data for Substances, Products, Organizations and Referentials (SPOR)
• Collection of data that will be managed and made available to the network, industry and
wider stakeholder community, in compliance with legislative requirements and the relevant
standards for privacy, data protection and security.
• Implementation of a new portfolio of services which will be supported by standardized data
governance and lifecycle management.
• Optimization of program benefits realized throughout the implementation of the roadmap
by involving and engaging effectively with stakeholders, leading to operating model
simplification and efficiency improvements.
SPOR – What you need to do
When preparing for compliance with new regulatory requirements, the industry often encounters
multiple solutions and a myriad of opinions on how to address the challenge. SPOR is no exception
to this and the only way to get to the right decision is with thorough education and complete
information. At Cunesoft, we strive to explain requirements of legal authorities and provide the best
advice.
Addressing the SPOR requirements means, for most companies, the need to find, analyze, and
connect the right data already captured in their organizations. This process can be very time-intense
and requires support from different departments:
Regulatory: What data needs to be available, who is responsible for what domain?
IT: What needs to be done to find and manage the data at all stages of
the product lifecycle? How can we be sure that the data silos will be IDMP-
ready as well to reduce duplicate effort and minimize move costs?
On the plus side, the early adopters of the SPOR data services will enable the realization of benefits
at all stages of the product lifecycle, because of the future integration of regulatory processes with
its standardized data and central data management services.
At Cunesoft, we recommend educating you and your regulatory team about the data SPOR will
require. In doing so, you can ensure that the information is accurate, you reduce the time pressure
later in the project, enjoy the above-mentioned benefits and give your company the chance to
smoothly grow into this new regulation.

3 Legislative Status of IDMP
To successfully implement the collection of IDMP information via electronic submission, a staged or
iterative approach is being utilized. This method can greatly improve the chances for success for
such a monumental effort and affords adaptability and flexibility throughout the entire effort.
Originally, Iteration 1 data requirements were expected to include 79 data elements. More recently
and still under discussion, Iteration 1 may include well over 120 data elements. The finalization of
the implementation guides will describe a final list of required data elements.
On the 7th
March, 2018 during an industry webinar by IRISS (https://iriss-forum.org/) a set of new
timelines was discussed. However, EMA didn´t publish an updated action plan, yet. Right now it can
only be assumed that IDMP will not be mandatory before 2020. Below you can find our understanding
of the discussed “new” timelines1
:
2018: Early draft of IDMP Implementation Guidelines released by late 2018
2019: Late draft of IDMP Implementation Guidelines released by mid 2019
2020: IDMP Submission mandatory by mid 2020 could be realistic as of today’s knowledge
Another critical aspect for this implementation is the establishment of the EMA’s master data
roadmap resulting in the deployment and availability of a system of standards referred to as SPOR
(see chapter 2 – SPOR what is it and why) – Substance, Product, Organization and Referentials.
The objective of this whitepaper is to offer several best practices approaches on how to prepare
your organization for IDMP compliance. Organizations of all shapes and sizes can benefit from the
observations made in this document.
1
Cunesoft provides no guarantee of the relevance, accuracy or completeness of the timeline.

4 The Industry Challenge – Organizational Readiness for IDMP
The basic fact is simple: IDMP will become mandatory for every Marketing Authorization Holder
(MAH). It is also true that IDMP will require the curation, management and submission of a much
wider collection of data when compared to xEVMPD – for example, information such as clinical
particulars, medicinal products, manufacturers, marketing authorizations, packaged medicinal
products and pharmaceutical products. It is also very likely that the required data for these
categories will come from several different data sources. One primary source will typically be
company internal systems such as spreadsheets combined with data in internal regulatory
information management (RIM) systems and other internal sources such as the ERP (Enterprise
Resource Planning) system.
This internal data will need to be combined, harmonized and synchronized with data from official
databases such as Global Substance Registration System (G-SRS2
) previously known as Global
Ingredient Archival System (GinAS) for substance related data, the Unified Code for Units of Measure
(UCUM) for strength definitions and the Pharmaceutical dose forms, units of presentation and
routes of administration (EDQM).
At Cunesoft we have analyzed of all required data fields defined within the ISO guidelines and offer
the following results:
*European Union Network Data Board
2
https://tripod.nih.gov/ginas/#/gsrs/
*

The proposed data elements include the following data entities:
IDMP Area IDMP Attributes
Medicinal Product Combined Pharmaceitical Dose Form
Medicinal Product Additional monitoring indicator
Medicinal Product Orphan Designation Status
Medicinal Product Name (Med.Product)
Medicinal Product Invented Name Part
Medicinal Product Scientific Name Part
Medicinal Product Strength Name Part
Medicinal Product Pharmaceutical Dose Form Part
Medicinal Product Formulation Part
Medicinal Product Intended Use Part
Medicinal Product Target Population Part
Medicinal Product Container or Pack Part
Medicinal Product Device Name Part
Medicinal Product Trademark or Company Name Part
Medicinal Product Time/Period Part
Medicinal Product Flavour Part
Medicinal Product Classification System
Medicinal Product Classification System Value
Marketing Authorisation Marketing Authorisation Number
Marketing Authorisation Country
Marketing Authorisation Authorisation Status
Marketing Authorisation Authorisation Status Date
Marketing Authorisation Procedure Identifier/Number
Marketing Authorisation Procedure Type (e.g. MRP/DCP)
Marketing Authorisation Country (national authorisation)
Marketing Authorisation Marketing Authorization Number (national authorisation)
Organisation Location Address
Indication Indication Text
Indication Indication as "Disease/ Symptom/ Procedure"
Indication Co-Morbidity
Indication Intended Effect
Pharmaceutical Products Administrable Dose Form
Pharmaceutical Products Unit of Presentation
Pharmaceutical Products Route of Administration
Ingredient Ingredient Role
Ingredient Substance
Ingredient Strength Range (Concentration)
Package description Package Description
Package description Package Item (Container) Type
Package description Package Item (Container) Quantity
Package description Material

The challenge of collecting and managing this broad array of data impacts the entire organization –
not just Regulatory Affairs. Regulatory Affairs at both the headquarters as well as with affiliates will
share data management responsibilities, product registration information, and ultimately own the
harmonization of this ‘master data’.
Figure 1 Departmental Involvement in IDMP from 2016 IRISS Forum Industry Survey on IDMP3
Your CMC teams will need or want access to a substance database such as G-SRS or an internal
IDMP-compliant system and they will also bear responsibility for collecting data about established
substances in use with your products, possibly define new substances not currently found in G-SRS
and interface with CMO’s to collect information about substances utilized from third parties.
Medical Affairs will be expected to provide information about clinical particulars – indications,
interactions, undesirable effects – in support of and encoded within your SmPCs. Familiarity with
and responsibility for coding terminology such as MedDRA, ATC and G-SRS will also be needed.
Finally, your supply chain, quality control and manufacturing functions will be impacted. From
tracking licensing information for all manufacturers associated with your product to details related
to packaging to awareness of and adherence to the registered physical characteristics of your
products.
IDMP readiness and compliance will be an organizational responsibility and ultimate is a strategic
initiative in most companies today.
Nearly all the leading multinational pharmaceutical companies (i.e. the top 50 pharma) we have
spoken with have defined IDMP as a strategic project and have allocated budgets ranging between 5
and 50 million Euro to accomplish IDMP compliance. Most of them have already completed their
IDMP scope analysis and have started implementing methodologies to gather the relevant IDMP
data from various data sources.
3
https://www.iriss-forum.org/news/iriss-publishes-the-results-readiness-surveys-for-idmp

5 Best Practices for IDMP readiness
5.1 General Process Steps – How to eat an elephant?
With IDMP, there are and will be significant challenges to face and overcome. Yet, as with every
journey, the first steps need to be taken. Or, in other words, answering the question “How to eat an
elephant? The answer: One bite at the time!
IDMP readiness can and should be treated as a formal project involving process steps that logically
build upon each other. The recommended best practices project steps for IDMP are outlined below:
5.2 Scope Analysis – Analyzing your data sources
The challenge for a successful IDMP implementation is the fact that structured data output is
required, while the data sources and existing data are typically unstructured. Therefore, a key
element for a successful IDMP project will be a comprehensive data source analysis. We recommend
the following steps:
1. Understand the ISO IDMP scope
a. Iteration 1
b. Beyond Iteration 1
2. Assess the differences between the data submitted in xEVMPD versus IDMP
3. Prioritize data gaps (mandatory, optional, conditional)
4. Analyze data sources
a. xEVMPD
b. External databases (G-SRS, EDQM, UCUM, MedDRA)
c. External partners (CMO, CRO)
d. Internal (Medical, Clinical, Legal, PV, Regulatory)
e. Internal systems RIM, ERP, LIMS, DMS, eCTD
f. Legacy data: file shares, excel
g. Documents
i. Electronic

ii. Paper
5. Collect sample data in order to determine the level of difficulty (i.e. collect data from an ERP
system or an external business partner).
Cunesoft offers a structured Excel-based data analysis tool to its clients. The tool contains a
structured list of all relevant ISO IDMP data fields, mapped with the available IDMP implementation
guidelines.
In the IRISS Forum’s 2016 Industry Survey on IDMP4
, over 80% of the respondents are currently
conducting a gap analysis of their information assets. By conducting the data source analysis, you
will be able to understand your information landscape and to identify your highest risk areas for
gaps and complexities.
5.3 Create a business plan
Based on the data source analysis, it will be possible to determine the efforts and costs for collecting
the relevant data from the best possible data sources.
The business plan should include a risk analysis, i.e. what happens if IDMP compliance is not
achieved. (i.e. calculate the potential 5% penalty of annual net sales revenue as potential risk factor
against the costs).
It is also important to include data visibility and related audit risks into the calculation. i.e. a broad
set of data will be submitted to the authority.
While becoming compliant with IDMP requirements implies certain costs, it is equally important to
build a base case that also identifies the benefits. Gathering a broad set of data such as the IDMP
data is a very powerful source for regulatory reporting and improving organizational effectiveness.
For example, drug efficacy can be analyzed on a much more granular (country or even patient) level
and insights can be used to increase the overall drug efficacy and patient safety.
5.4 Using IDMP-savvy technology versus manual data entry
An important consideration for the execution of the IDMP project will be whether to perform the
IDMP data entry manually, to outsource the curation to an outside firm, or to build/acquire a
software tool to support the IDMP submission creation process.
In May 2015, Cunesoft conducted a survey with 75 life sciences companies across Europe. This
revealed that more than 85% are considering the acquisition and use of a tactical software tool or a
strategic software solution. Less than 5% plan manual data entry.
4
https://www.iriss-forum.org/news/iriss-publishes-the-results-readiness-surveys-for-idmp

The IRISS Forum survey also looked into the intended technical approach for provision of IDMP data
and found that 69% of respondents intend to submit the information via the gateway:
5.4.1 Mining your IDMP data from existing sources
The reality is that IDMP can be collected and entered manually. However, the reasons for using
technology to gather and maintain IDMP are driven by initial and ongoing operational costs. The
potential costs for manual data maintenance of hundreds of data fields per European market
authorization can be significantly higher when compared to using usable and efficient software
designed specifically for IDMP submission compilation and maintenance.
In terms of the initial curation of the data needed for populating IDMP information, recent
technology innovations have made the concept of document data mining a reality. With a
substantial percentage of the Iteration 1 data currently living in documents such as an SmPC, an

opportunity presents itself to utilize intelligent document data mining technologies to automate the
extraction and encoding of nearly half of the required data. Cunesoft’s cune-Distiller is a document
data mining solution that is specifically configured to extract, encode and merge IDMP data from
SmPC documents, xEVMPD files and even CTD documents such as those found in the 3.2.P section of
a submission.
5.4.2 IDMP data mapping with coding systems
One of the new challenges with IDMP are coding requirements and controlled vocabularies. As
described in a previous section, external databases will need to be used to map IDMP data with
multiple standard coding systems.
Looking at iteration 1, for example, clinical particulars such as indications have to be extracted from
the SMPC and also need to be referenced with the corresponding MedDRA codes, low level terms
and SOC classifications. Active substances and Excipients used in marketed products need to be
mapped with G-SRS codes. Additionally, other standard terminologies such as Dosage Forms,
Organizations and Routes of Administration (to name a few) will have to be coded via yet to be
released referential and organization data bases by the EMA.
5.4.3 IDMP data staging and curating
Following curation of the initial data, companies looking to utilize a technology solution consider
management platforms that align with the IDMP data model and can produce compliant IDMP data
files for submission.
Unstructured IDMP data, prepared as described in the section data mining and data mapping, will be
required to be matched and staged with other structured data, coming from RIM, MDM, ERP or
other systems.
Cunesoft offers cune-IDMP – a module in its Regulatory Operations Platform – with a growing
number of companies across Europe utilizing the software to gather and manage their IDMP data. In
nearly all cases, these companies have achieved an ROI in less than 6 months.
5.4.4 IDMP data maintenance and expected lifecycle
The entire IDMP data model includes 1200 data fields. Most likely, when reaching iteration 3, 500-
750 data fields will need to be submitted and maintained. Manual maintenance of such large
amounts of data will not scale. It is recommended that each IDMP project includes a strategy for
ongoing data maintenance.
We fully expect that the IDMP submission life cycle management will follow the current xEVMPRM
life cycle management, which include electronic message receipt of authority acknowledgments.

When using software technology for IDMP data maintenance, a gateway connector to facilitate the
data transfer (send and receipt) to and from the health authority should be considered.
Furthermore, the software technology used should include business rules to manage data changes
as automated as possible. For example, an alert should be sent internally to the IDMP responsible
person, if IDMP relevant data is changing in any other system. Ideally such changes will automatically
be updated by a well-designed IDMP software solution.
6 IDMP solved via Regulatory Master Data Management
6.1 Single Source of Truth
Master Data Management (MDM) approaches are being used in many organizations to create a
single source of truth for related data. For example, the manufacturing division uses an Enterprise
Resource Management (ERP) system, which contains production-related master data. Finance
typically uses another instance or module of the ERP system or has its own finance master data
system. Sales uses a Customer Relationship Management System (CRM), which consolidates all
customer related data in one system for sales and marketing. In some case, the CRM system may be
connected and integrated into the ERP system.
Within life sciences organizations, Regulatory Affairs has significant strategic importance. However,
in most cases, no regulatory master data management systems are available or implemented.
Unfortunately, in many companies, we have observed an Excel sheet-based regulatory data
management approach.
Regulatory Information Management System (RIMS) have been the first attempt to manage broader
regulatory data within a single system. In some cases, the existing RIMS environment can be the
base for managing IDMP-related data, but would need to be customized significantly to also become
the single source of truth. The graphic below describes the high level concept for a regulatory master
data management.
Why is a single source of truth important? Let’s look at a very simple example and its complex
implications - Ibuprofen 5mg: The substance itself would be described in the submission dossier.
The IDMP relevant substance code would need to be extracted via G-SRS and the strength
terminology would come from UCUM. Within an IDMP system, you will need to consolidate these
different data sets and combine them to one compound data set, the IDMP data set. Conducting this
data collection manually just for a single medicinal product can be time consuming. Now, let’s
explore a very realistic scenario of a data change that is happening in one of the internal source
systems: If, for example, G-SRS is applying a change but there is no notification in place that tells you
to also update your IDMP compound data set in the IDMP system, the ability to keep everything
synchronized and harmonized becomes nearly impossible.

6.2 Benefits of solving IDMP via a Regulatory Master Data Management
Implementing a regulatory master data system for the purpose of IDMP will enable organizations to
gain process benefits, cost savings, increased product quality and ultimately will set the foundation
to increase their competitive positioning. The following benefits can be achieved:
6.2.1 Reduce IDMP submission time
With an information management platform specifically designed to meet IDMP data collection,
validation and submission creation requirements, the process of producing an IDMP submission is
quite rapid.
6.2.2 Reduce IDMP preparation time to a minimum
By leveraging a regulatory master data management approach, the re-use of data and metadata will
be enabled. Data redundancies are eliminated. Data accuracy is guaranteed. Organization-wide data
collaboration is achieved. External data providers (i.e. manufacturing partners) can also be
integrated in the data collection process.
6.2.3 Increase working speed from hours to minutes
By providing users with unique process optimization features such as integrating external data bases
(i.e. G-SRS, EDQM, UCUM etc.), the data collection and data management process are reduced.
Familiar and useful task management allows users to distribute work items and track the completion
of these tasks.
6.2.4 Reduce data maintenance costs by 70%
A solution designed with IDMP needs in mind can ensure automatic data updates via defined
business rules as well as automatic data collection from any type of other internal source system.
7 Summary and Conclusions
Submissions of IDMP data for already approved products will become legislatively effective in
Europe in late 2019. FDA and Health Canada have given their commitment to ISO IDMP and are
expected to follow with a legislative deadline shortly thereafter. In July 2017, the FDA announced its
“Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data
Elements and Terminologies” call for comments. The FDA describes this as include “…data elements
and terminologies for the electronic submission of PQ/CMC data. The establishment of standardized
pharmaceutical quality data elements and terminologies will provide opportunities for FDA and
industry to transform PQ/CMC submission data into a readily useable electronic format. As a result,
these established data elements and terminologies will improve the efficiency and quality of the
drug review process.” For more information, visit https://www.regulations.gov/docket?D=FDA-
2017-N-2166. Even when the Brexit and EMA´s move from London to Amsterdam slowed done the
implementation process, IDMP is developing fine. However the currently published timelines suggest
that there will be no further draft guideline for IDMP before Q4 2018. For more information, visit
http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2018/01/WC500242388.p

df PMDA Japan is participating in international ISO IDMP update meetings and is expected to join
IDMP as well. In other words, the conclusion can be made that IDMP will become a global standard.
Cunesoft recommends that all organizations see IDMP as a “opportunity for a strategic evolution”.
Publicly available studies confirm that for today’s pharmacovigilance related pharmaceutical product
management, up to 100 minutes per product per year are being used to simply keeping the data up
to date. With the increased complexity of IDMP, this yearly effort will increase by a factor of 3 to 5
times. According to a recent study conducted by the University of Leipzig, Germany, it is estimated
that with master data management, the yearly maintenance time for comparable data records such
as pharmaceutical product data, can be reduced to 20 minutes per year.
Therefore, when looking at the complexity of IDMP, the logical solution is the implementation of a
regulatory master data management system that not only fulfills IDMP compliance requirements,
but will also provide tremendous efficiencies – and savings – for your regulatory information
management.
Contact Details:
Cunesoft GmbH
Luise-Ullrich-Strasse 20
80636 München
Germany
Phone: +49 (0)89-235 14741
Cunesoft Inc.
103 Carnegie Center, Suite 300
Princeton, NJ 08540
USA
Phone: +1 (609) 955-6348
Website: www.cunesoft.com
Email: info@cunesoft.com
Cunesoft can provide help with:
• IDMP Training
• IDMP Data Analysis Tools and Services
• Business Case Creation Workshop
• Regulatory Master Data Management Workshop
• IDMP software cune-IDMP & cune-Distiller

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The IDMP Challenge - Whitepaper on ISO IDMP by Cunesoft