Contract Manufacturing Organizations (CMO)

Contract Manufacturing Organizations (CMO)


As the extended workbench of the pharmaceutical industry, pharmaceutical contract manufacturers cover both the production and the development of pharmaceutical substances. They operate predominantly in projects and have to organise their development and production processes as efficiently as possible. A high number of customer audits characterises their business.


As a result, quality management plays a central role in these companies, as it has to meet the requirements of a wide range of authorities and company audits. Contract manufacturers, in contrast to research-based pharmaceutical companies and generic drug manufacturers, are much more focused on their customers and align their processes to this.


We have built up deep industry and process know-how and advise along the entire product life cycle:

DHC Consulting Solutions and Services for pharmaceutical contract manufacturers

As specialists in “Best in Class” processes in the life sciences, in addition to our core competencies we can advise you on the following topics:

Optimisation and standardisation of business processes and IT systems through the implementation of SAP S/4HANA (SAP Intelligent Enterprise)

for:

  • Supply Chain Management
  • Sales
  • Manufacturing
  • Procurement
  • Warehouse Management
  • Quality Management
  • Plant Maintenance
  • Finance
  • Human Resources

Here you will find our consulting services for a fast, secure and compliant implementation of e.g. SAP S/4 HANA.

Einführung/Umsetzung IDMP in SAP

for:

  • Definition of the specific IDMP requirements
  • Identification of the necessary data
  • Creation of the data model for IDMP
  • Implementation and validation of the IDMP solution in SAP (Polaris)
  • Validation of the implementation

Here you can find our consulting services on the topic of IDMP.

Realisation of a standardised LIMS with SAP QM

for the processes:

  • Quality planning
  • Quality inspection (incoming goods inspection, in-process control, release inspections, supplier certificates)
  • Quality costs
  • Product release
  • Certificates of Analysis
  • Supplier qualification
  • Test equipment management
  • Quality evaluations
  • Audit management
  • Stability studies
  • Statistical process control

Here you will find our consulting services on the subject of LIMS with SAP QM.

Implementation of a global deviation / CAPA system based on SAP S/4HANA Quality Management, SAP Quality Issue Management (QIM) or SAP Quality Issue Resolution (QIR)

for:

  • Customer complaints
  • External and internal problem reports
  • Supplier complaints
  • Audit findings
  • Measures management
  • GxP-compliant documentation of deviations with the measures taken

Here you will find our consulting services on the subject of deviation management/CAPA, SAP Quality Issue Management (QIM) and SAP Quality Issue Resolution.

Design and implementation of software validation

  • ERP systems
    • SAP (S/4HANA, ECC, Business One)
    • Oracle Applications
  • Microsoft (Navision, D365)
  • Cloud-based systems
  • Cloud infrastructure service providers
    • Amazon Web Services
    • Microsoft Azure Cloud
  • Manufacturing Execution Systems (MES)
    • SAP Digital Manufacturing Cloud
  • Microsoft Office applications with Excel
  • Document management systems (eDMS)
    • EMC Documentum incl. special interfaces with QUMAS, DocCompliance, First Doc, McLaren, C6
    • Saperion
    • ELO, etc.
  • Laboratory Information Management Systems (LIMS)
    • Labware
    • SampleManager
    • KinLIMS
    • SAP QM
  • Application Life Cycle / IT Service Management Systems (ITSM)
    • SAP Solution Manager
    • ServiceNow
    • HQ Quality Center
    • BMC Remedy Action Request System
    • Frontrange ITSM, etc.
    • Siemens Polarion
  • IT systems in the clinical area
  • Clinical Trial Management Systems (CTMS)
  • IDMP systems (Gramont, etc.)
  • Pharmacovigilance systems (ARISg, PV-Works, etc.)
  • In-house software developments
  • Facility Management Systems


Here you will find our consulting services on software validation/computer system validation (CSV).

Digitalisation of Validation

Among other things, DHC provides support in:

  • Conception of the digital validation strategy
  • Automation and digitalisation of validation processes
  • Central management of validation documentation
  • Automated testing

Here you will find our consulting services on the topics of Digital Validation Scorecard, VxP | Validation Platform.

Managed Services in the Validation of SAP Systems

  • Adoption of change processes
  • Maintenance of the valid state
  • Adaptation of validation documentation

Here you will find our consulting services on the topic of Managed Validation Services.

REQUEST INFORMATION!

Learn more about the DHC consulting topics for pharmaceutical contract manufacturing!

WHY CHOOSE DHC?

Each industry has its special features and specific requirements, such as the relevance of particular economic, legal and political circumstances, specific requirements for quality and safety, and so forth.

This is why we supplement our core topics of

with our own, industry-specific consulting services for pharmaceutical contract manufacturers. These services are based on our broad-based process know-how, combined with our long experience in the relevant sectors. This secures a long-term competitive advantage for your business.

Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe
Switzerland
Carsten Buri

CEO and Director Sales & Marketing, DHC Switzerland

phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri

Customers

WEBINARS AND EVENTS

09. Februar
LSA web session (in German)

Validation of SAP S/4HANA on-premise and Private Cloud Edition

The web session considers the validation requirements for SAP S/4HANA on-premise vs. cloud systems.

more
02. März
DHC & LSA Websession (in German)

Manage inspection plan changes with change folders in SAP S/4HANA

Learn how to quickly and easily manage the release process of inspection plans via change folders.

more
03. März
DHC web session (in German)

Digitalization and quality assurance in Villeroy & Boch production – Dining & Lifestyle

Presentation of QM/QA and digitization subprojects of our customer Villeroy & Boch

more
10. März
DHC web session (in German)

Validation of a SaaS solution, using the example of SAP DMC

Learn what needs to be considered when using GxP-relevant public cloud systems with regard to validation.

more
16. März
DHC & LSA Web session (in German)

SAP S/4HANA Implementation and Validation in the Life Sciences Industry

Find out what benefits the LSA approach offers you for the optimal, validated deployment of S/4HANA.

more
24. März
DHC & SAP Web session (in German)

QM innovations in SAP S/4HANA on-premise and cloud

Dr. Manfred Schulz, Product Manager QM at SAP SE, will present the QM highlights of the latest SAP S/4HANA releases.

more
29. März
DHC web session (in German)

Test equipment management and monitoring with SAP S/4HANA

Presentation of SAP-integrated test equipment management with all functions for company-wide management of operational test equipment.

more
20. April
DHC & LSA Web session (in German)

SAP S/4HANA Transformation and Validation in the Life Sciences Industry

Learn everything about phases for the system transformation (system conversion) of an SAP ECC to S/4HANA with integrated validation.

more
DHC WEB SESSIONS

Our web sessions are provided as a free service for DHC customers and potential customers.