Identification of Medicinal Products (IDMP) with SAP
- 30+ years of SAP and compliance experience
- Industry expertise in Life Sciences
- SAP Silver Partner
IDMP with SAP
With Identification of Medicinal Products (IDMP), pharmaceutical companies must submit extensive structured product data to authorities such as the EMA. For Marketing Authorization Holders, this means consistently managing and providing regulatory data about products, active substances and authorizations across systems.
Implementing IDMP is not only a regulatory obligation, but also an opportunity to centrally consolidate product data and make regulatory processes more efficient.
DHC supports pharmaceutical companies in efficiently implementing IDMP requirements with SAP – from data strategy through implementation to compliant system operations.
Challenges with IDMP in SAP
Consolidate Product Data
IDMP requires structured information about medicinal products, active substances and marketing authorizations, which is often distributed across multiple systems.
Meeting ISO Standards
Pharmaceutical companies must systematically prepare extensive IDMP data according to ISO standards and regularly report to authorities such as the EMA.
Integrate System Landscape
Product data often originates from ERP, RIMS, CTMS or document systems and must be centrally consolidated and managed.
IDMP Data Management with SAP
With the SAP IDMP App Polaris, pharmaceutical companies have a powerful solution for centrally managing regulatory product data and automatically submitting it to authorities.
Through integration into the SAP landscape, companies can efficiently manage their regulatory data and simultaneously use it for internal processes.
The application enables:
- Consolidation of regulatory product data
- Structured management according to IDMP ISO standards
- Automated creation of regulatory submissions
- Integration into existing SAP system landscapes
- Use of modern SAP Fiori user interfaces
More about IDMP with SAP?
DHC Consulting Services
Scoping & PoC
Analysis of the impact of the SAP IDMP App Polaris on processes and systems, assessment of effort, costs and risks, and review of functional requirements to define the optimal implementation scope and an initial implementation roadmap.
Implementation
Our services include:
- Design and development of the IDMP data model
- Implementation of data preparation workflows
- Setup of data consolidation rules
- Development of controlled vocabularies
- Creation of reporting structures
- Integration with SAP S/4HANA
- Interfaces to systems such as RIMS or CTMS
- Implementation of electronic data submission to authorities
- Software validation of the system
Services & Support
Even after go-live, we support you in operating your IDMP solution.
Our services include:
- Second and third level support
- Support for system adjustments
- Further development of the solution
- Consulting on new regulatory requirements
Our SAP and life sciences experts ensure stable and efficient operations.
Why DHC – Your Specialist for CAQ with SAP
DHC has been supporting pharmaceutical companies in the implementation and validation of SAP systems for over 30 years.
Our clients benefit from:
- comprehensive SAP and life sciences expertise
- deep knowledge of regulatory requirements
- experience in regulatory affairs and data management
- integrated implementation of SAP projects and software validation
- long-term support in operating SAP systems
IDMP with SAP
Are you planning to implement IDMP requirements with SAP or want to efficiently manage your regulatory product data?
Trust through Experience
We are the specialist for all QM, QA and QC solutions based on SAP ERP.
Frequently Asked Questions about IDMP with SAP
Must all pharmaceutical companies implement IDMP?
IDMP requirements generally affect all Marketing Authorization Holders (MAHs) who market medicinal products on the European market. Companies must submit structured data about their products, active substances and authorizations to authorities such as the European Medicines Agency (EMA).
What data must be reported under IDMP?
An integrated SAP approach reduces interfaces, system maintenance, duplicate data management and validation effort. This leads to long-term reductions in IT operating costs, change management effort and audit risks compared to external CAQ specialized solutions.
What risks exist with parallel CAQ and SAP system landscapes?
Separate systems increase complexity, integration effort and validation scope. They also create media discontinuities, inconsistent KPIs and potential compliance risks during audits.
Is CAQ with SAP S/4HANA strategically future-proof?
Yes. QM with SAP is fully integrated into SAP S/4HANA and part of the SAP roadmap. Companies avoid dependencies on third-party providers and benefit from a stable, long-term architecture.
How does CAQ with SAP influence an S/4HANA transformation?
An integrated CAQ approach should be incorporated into the S/4HANA roadmap early on. Subsequent integration of external CAQ systems significantly increases data migration, testing and validation effort.
When is it worth switching from an existing CAQ system?
A switch is advisable when:
- SAP is the strategic core system
- high interface costs arise
- validation effort needs to be reduced
- global standardization is planned
- or an S/4HANA transformation is upcoming
IDMP with SAP
Are you planning to implement IDMP requirements with SAP or want to efficiently manage your regulatory product data?