Managed Validation Services

Companies in the regulated environment face numerous challenges with regard to computer system validation due to high regulatory requirements and an increasing pace of change in the IT sector. With DHC Validation Services, we support you in meeting these challenges, reducing your workload and maintaining the valid status of your computer systems in a cost-efficient and high-quality manner. You benefit from our decades of experience and gain more sustainable compliance and security for the operation of your GxP-relevant computer systems at lower costs. Whether fully integrated into your processes or through selective support, our experienced consultants relieve your employees in business, IT and quality assurance in the numerous aspects of validation. Under your control, a dedicated service team supports you, for example, in processing your IT changes for a GxP-relevant computer system. This can include your SAP systems such as SAP S/4HANA, other complex ERP systems (e.g. Microsoft D365) and even cloud-based systems.

With the DHC Managed Validation Service, we offer you a comprehensive, needs-based solution for the validation of your GxP-relevant IT systems – flexible, efficient and customised.

Your benefits:

Fast support: access to experienced CSV experts in the event of staffing or time bottlenecks.
Relief for your teams: Support or takeover of recurring tasks such as release changes or change management.
High compliance security: Ensuring GxP-compliant operation of your IT systems.
Cost efficiency: Transparent and predictable costs with fixed quarterly budgets.
Process-integrated solutions: Seamless integration of our experts into your processes, from selective support to complete outsourcing.

Covered systems:

Our service covers a wide range of IT systems – both cloud and on-premise, including:

SAP systems (S/4HANA, ECC, Business One, SuccessFactors, and many more)
Manufacturing Execution Systems (MES)
Microsoft D365 and Office applications
IT service management (ITSM) systems
Quality and document management systems (Trackwise, DMS)
Laboratory IT (LIMS, CDS), clinical trial management systems
Mobile device management (MDM), device qualification and process controls
etc.

LIFE CYCLE DOCUMENTATION SERVICES

With our Life Cycle Documentation Services, we ensure that validation documentation is always up-to-date and complete, provide support with the creation and maintenance of relevant documents and, if required, also take care of document management, including review and approval.

TESTING SERVICES

Our testing services provide you with comprehensive support in test management – from the creation of test plans and test reports to support in test execution and regression tests through to the review of test scripts and protocols.

CSV EXPERT SERVICES

With our CSV Expert Services, our experts provide you with ongoing support for complex CSV issues or take them over completely – from supplier qualifications, periodic reviews and infrastructure qualification to cloud monitoring, data integrity and audit trail reviews, audits and deviation management.

CHANGE MANAGEMENT SERVICES

With our change management services, we support system changes from an IT QA perspective throughout the entire process – from the review of change requests to the final go-live, including the release of changes and transports, customised validation documents and tests carried out.

QUALITY-DRIVEN

Local service team of DHC consultants with years of experience.
In-depth knowledge of regulatory requirements and the industry.
Expertise in the validation of computerized systems, from complex ERP systems (e.g. SAP S/4HANA, Microsoft D365), to cloud-based systems and SaaS systems, to Excel sheets.

SERVICE ORIENTED

From needs-based & flexible support for the specialist department, IT and quality assurance through to a fully managed validation service
Depending on the service level, we are integrated into your compliance processes and work in cooperation with you
From contract-based collaboration to full service level agreement (SLA)
Consistently high quality – proven by KPI-based management

Permanent contact person

We define the service catalog together with you and then provide you with a DHC service team that knows your requirements and processes and can help you further.

Knowledge transfer

By transferring knowledge from our team to your employees through experience from more than 500 projects and continuous further training, your internal understanding of compliance is constantly increasing.

Increasing efficiency

Integrating DHC’s Validation Services into your IT processes (e.g. change management process) makes them more efficient and saves you valuable time.

More flexibility & independence

We absorb your 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 of searching, onboarding, equipment and, above all, the time required to coordinate your own CSV resources are eliminated.

Consistency and quality

Use the DHC service team, which has in-depth CSV knowledge, many years of experience and sound knowledge of the regulatory requirements and processes in your industry, to keep your systems in a consistently high quality and valid state.

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

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

Switzerland

Carsten Buri

CEO and Director Sales & Marketing, DHC Switzerland

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

Managed Validation Services