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EnglishManaged Validation Services
From temporary support
to the all-round carefree package
MANAGED VALIDATION SERVICES
With the DHC Managed Validation Services, we support you in maintaining the valid state of your computer systems. Here, we cover different ERP systems (e.g. S/4HANA or Microsoft D365) as well as multiple deployment options, such as cloud-based systems and on-premise systems. Integrated into your processes, experienced consultants support and relieve the burden on your business, IT and quality assurance staff, and work together to process changes under your control.
CHANGE MANAGEMENT PROCESS TODAY VS. MANAGED VALIDATION SERVICES
You can find out how we can support you in the individual phases of the change management process here:
Today:
Lack of time to prepare and apply for the change.
With the DHC Managed Validation Service we support you by:
- Coaching the Change Request preparation
Today:
Lengthy analysis of affected GxP-critical processes as well as documents.
With the DHC Managed Validation Service we support you by:
- Identification and preparation of documents for the business (co-writing and coaching)
- Support with the validation process
Today:
Hours of detailed change request validation.
With the DHC Managed Validation Service we support you by:
Checking the change request for consistency and completeness
Today:
Lack of time to oversee document revision.
With the DHC Managed Validation Service we support you by:
- Validation document adaptation (co-writing and coaching).
- Document preparation (co-writing and coaching)
- Creation of test plans
- Checking the documents created by IT
- Document review and approval when handed over for testing
Today:
High effort to supervise the tests and control the test protocols.
With the DHC Managed Validation Service we support you by:
- Document review and approval before handover for testing
- Review of test protocols
- Performing Q-Check
- Mapping in the test management tool
- Test execution
Today:
High time pressure to verify that documents are complete and correct.
With the DHC Managed Validation Service we support you by:
-
- Release of the productive implementation
- QA check
- Preparation of final reports
SERVICES AT A GLANCE
Creation of:
- Validation plan
- Validation report
- Templates
- Graphical process modelling
Co-writing & coaching in document production:
- User Requirements Specification (URS)
- Functional Specification (FS)
- Design Specification (DS)
- Functional Risk Assessment
- Risk analysis/risk rating
- Training material
- Test plan
- Standard Operating Procedures (SOPs)
- Document review
- Document Handling
- Document release management
- GxP-compliant document management
- Co-writing & coaching in the creation of test plans
- Test management
- Support in test implementation
- Support for system changes from the change request to the go-live date
- Coaching in the creation of change requests
- Document review
- Document handling
- Document release management
- GxP-compliant document management
THE CONCEPT
OUR TEAM
- Local service teamof DHC consultants with many years of experience and in-depth knowledge of regulatory requirements and the industry
- Expertise in thevalidation of computerised systems
- From complex ERP systems (SAP S/4HANA, Microsoft D365), cloud-based systems and SaaS systems, to Excel sheets
SERVICE ORIENTED
- Fromdemand-oriented & flexible support of the specialist department, IT and quality assurance to a fully managed validation service.
- Depending on the service level, we are integrated into your compliance processes and work in cooperation with you
- Von der vertragsbasierten Zusammenarbeit bis hin zum Full Service Level Agreement (SLA)
- Consistently high qualityt – proven by KPI-based management
From selective support to a fully managed validation service
YOUR ADVANTAGES
Permanent contact person
We define the service catalogue together with you and then provide you with a DHC service team that knows your requirements and processes and helps you further.
More compliance awareness
Through knowledge transfer from more than 500 projects from our team to your employees and continuous training.
Increasing efficiency
By integrating DHC’s Managed Validation Services into your IT processes (e.g. change management).
More flexibility & independence
We absorb capacity bottlenecks and give you time to focus on your core business.
Cost reduction and transparency
Our service-oriented pricing model guarantees you full cost transparency.
The costs for search, onboarding, equipment and above all coordination are eliminated.
Save Time
There is no need to search for and onboard “suitable” consultants, simply use the DHC service team, which already knows your requirements and processes.
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Learn more about DHC’s Managed Validation Services!
DHC – YOUR SPECIALIST FOR MANAGED SERVICES
Benefit from our expertise on the topic of “Managed Services
- More than 25 years of expertise in IT consulting
- Numerous successfully implemented customer projects
- Long-term and trusting cooperation with our customers (services)
- Proven industry expertise in pharmaceuticals/life sciences and medical technology
- High level of knowledge transfer
Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com
CEO and Director Sales & Marketing, DHC Switzerland
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch
CUSTOMERS
