Contract Manufacturing Organizations (CMO)

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.

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.

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.

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.

• 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).

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.

• 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.