Managed Validation Services
- GxP and IT Expertise from a Single Source
- 30+ Years of Experience in Regulated Industries
- SAP Silver Partner
DHC Validation as a Service for Regulated Companies
Companies in regulated industries are under growing pressure: increasing regulatory requirements meet dynamic IT landscapes with new technologies such as cloud and AI platforms and ever shorter release cycles. This increases the need to validate computer systems faster, more frequently and more efficiently.
With DHC Validation as a Service, you relieve your teams operationally and secure the valid state of your GxP-relevant systems cost-efficiently and in high quality. Your QA and CSV management remains in the steering role, regulatory responsibility remains entirely with you. A dedicated DHC service team takes over clearly defined operational task areas and integrates in a structured manner into your governance and quality processes.
Validation as a Service is therefore not outsourcing of responsibility, but a scaling instrument for your compliance organization.
Who Benefits from Validation as a Service?
Our services are deliberately modular and suitable for both mid-sized companies and international corporations. Whether fully integrated into your processes or through targeted support, our experienced consultants relieve your employees in business, IT, and quality assurance in the numerous aspects of validation.
Smaller organizations also benefit from clearly defined service modules and transparent budgets – without permanently building additional FTE.
The model is particularly relevant when:
- Internal CSV resources are limited
- Project peaks or transformation programs are upcoming
- Release and change volumes are increasing
- Cloud or SAP programs require additional validation capacity
- Audit findings reveal structural weaknesses
- Compliance costs need to become more predictable
Demand-driven & Flexible Service Models
With DHC Validation as a Service, we offer you a comprehensive, demand-driven solution for validating your GxP-relevant IT systems – flexible, efficient and tailored.
Your benefits:
- Fast support: Access to experienced CSV experts during personnel or time constraints.
- 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 targeted 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 more)
- Manufacturing Execution Systems (MES)
- Microsoft D365 and Office applications
- Quality and document management systems (Trackwise, DMS)
- Lab IT (LIMS, CDS), Clinical Trial Management Systems
- Mobile Device Management (MDM), equipment qualification and process controls
- and more
Our Service Modules
Life Cycle Documentation Services
- Initial Maturity Check:
Ranking of maturity level with our proprietary AI Scorecard - Strategic Alignment:
Clarification of goals and application areas for AI in the corporate strategy. - Data Strategy:
Analysis of workflows, data flows, data sources and data management.
- Governance and Data Sovereignty:
Clarification of authorization concepts and copyrights. - Infrastructure:
Consulting for digital infrastructure requirements. - Corporate Culture:
Assessment of corporate culture regarding openness to innovation and competence in data capture and qualification.
Testing Services
With our testing services, we provide comprehensive support in test management – from creating test plans and test reports to supporting test execution and regression tests to reviewing test scripts and protocols.
CSV Expert Services
With our CSV Expert Services, our experts support you permanently on complex CSV topics or take them over completely – from supplier qualifications, periodic reviews and infrastructure qualification to cloud monitoring, data integrity and audit trail reviews to 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 reviewing change requests to final production deployment, including release of changes and transports, adapted validation documents and executed tests.
The Concept
OUR TEAM
- Local service team of DHC consultants with many years of experience.
- Deep 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 and SaaS systems.
SERVICE-ORIENTED
- Demand-driven service levels offer numerous support options.
- From demand-oriented & flexible support of business departments, IT and quality assurance to full managed validation service, where we are integrated into your compliance processes and work in collaboration with you.
- Clearly defined and agreed service scope (Service Level Agreement).
- Consistently high quality and cost transparency – proven through KPI-driven management.
Your Benefits
Why DHC
DHC has been supporting companies in regulated industries in validating complex IT and system landscapes for over 30 years. We have deep knowledge of regulatory requirements (GAMP, FDA, GxP, ISO 13485, …).
Our strength lies in the combination of GxP compliance expertise, IT architecture understanding and practical implementation experience.
With our own validation methodology and the DHC Smart Validation Accelerator, we support companies in efficiently structuring validation processes and operating them in a long-term audit-ready manner.
Trust through Experience
We are the specialist for all QM, QA and QC solutions based on SAP ERP.
“DHC convinced us with their efficient and secure validation concepts as a consulting partner.”
FAQs about Managed Validation as a Service
Does the regulatory responsibility remain with us?
Yes. The overall regulatory responsibility remains with the regulated company at all times.
DHC takes on clearly defined operational tasks within contractually regulated governance and role models. Control and decision-making authority remain with you.
Ersetzen Managed Validation as a Services unsere interne Validierungsorganisation?
No. Validation as a Service does not replace responsible persons but relieves them operationally.
Your QA and CSV management remains in the steering role. DHC flexibly complements your organization – as needed.
Is this model also suitable for mid-sized companies?
Yes. Our services are modularly scalable – from targeted support to comprehensive guidance. Smaller organizations also benefit from predictable budgets without having to build additional internal FTE.
Is Validation as a Service more cost-effective than building internal resources?
In many cases yes – especially during project peaks, release-intensive systems or skills shortages. Recruiting, onboarding, training and coordination efforts are eliminated. At the same time, you remain flexible.
How is audit readiness ensured?
Through clearly defined processes, documented service level agreements, KPI-supported reporting and structured lifecycle management of your systems. DHC also actively supports regulatory inspections and customer audits.
Does a dependency on DHC arise?
No. Our collaboration is designed for transparency, knowledge transfer and clearly defined service scopes. You retain control at all times and can flexibly adjust scope and intensity.
DHC Managed Validation Services
Relieve your organization and permanently secure the valid state of your systems – with DHC Managed Validation Services.
