Cloud & SaaS Validation
- GxP and IT Expertise from a Single Source
- 30+ Years of Experience in Regulated Industries
- SAP Silver Partner
Validation of Cloud Computing Systems
Cloud and SaaS platforms are today central building blocks of modern IT strategies in pharma, biotechnology and medical technology. They enable faster implementation, global scaling and significantly shorter innovation cycles.
At the same time, new regulatory challenges arise. Responsibilities shift between provider and user, system control is limited and updates occur outside one’s own governance.
For management, QA and IT leadership, three central questions therefore arise:
- How can cloud risks be managed from a regulatory perspective?
- How does the company remain audit-ready despite automatic updates and short release cycles?
- How can cloud innovation be leveraged without increasing compliance risks?
DHC supports companies in validating cloud and SaaS systems in a GxP-compliant manner and operating them in a permanently audit-ready way.
Challenges with Cloud & SaaS Systems
Shared Responsibility
Even with outsourced operations, regulatory responsibility remains entirely with the company.
Dynamic Releases
Regular updates by the provider require a robust change & periodic review concept.
Supplier Control & DI
Authorities expect qualified providers, transparent contracts, robust audit trails and effective monitoring.
DHC Best Practice for Cloud System Validation
- A structured validation approach
- Standardized SOPs, templates and training materials
- Supporting tools for planning, execution and documentation
For cloud systems, this methodology has been specifically extended and considers typical characteristics of modern platform architectures, including:
- Limited system control by the operator
- Management of cloud providers and service providers
- Data protection and data integrity
- Continuous software updates and release cycles
More about Validation of Cloud-based Systems?
DHC Consulting Services
Compliance Check & Strategy
We develop a robust cloud governance and validation strategy with you – tailored to your regulatory environment and IT architecture.
Typical services:
- Cloud readiness assessments
- Supplier qualification and audits
- MSA, SLA and quality agreement reviews
- Data integrity assessments
- Development of a cloud CSV framework
- Workshops and coaching for QA and IT managers
Validation of Cloud Systems
We handle the risk-based validation of your cloud systems.
Typical services:
- Prospective or retrospective cloud validation
- Risk analyses and requirement management
- Test management and documentation
- Audit trail and data integrity assessments
- Change and release management processes
- Remediation programs
Managed Validation Services
With our Managed Validation Services, you permanently secure the valid state of your cloud systems – even with dynamic updates and growing system landscapes.
Typical services:
- Release and change assessments
- Periodic reviews
- Compliance monitoring
- Audit support
- Further development of your CSV framework
Digitalization of Cloud Validation: DHC Smart Validation Accelerator
To accelerate and digitalize validation processes, DHC developed the DHC Smart Validation Accelerator, a modern validation platform that significantly increases the efficiency of validation processes through the use of Artificial Intelligence (AI) and full integration into the SAP ecosystem with SAP Cloud ALM and Tricentis.
Why DHC – Your Specialist for Cloud & SaaS Validation
DHC has been supporting companies in regulated industries in the validation of GxP-relevant IT systems for over 30 years.
We combine cloud technology, IT governance and regulatory compliance in an integrated DHC Best Practice CSV methodology.
With the DHC Smart Validation Accelerator, we digitalize validation processes for modern cloud architectures.
This ensures that your cloud systems are operated in a GxP-compliant and audit-proof manner – as a stable foundation for your digital transformation.
Cloud & SaaS Validation
Trust through Experience
We are the specialist for Cloud & SaaS Validation.
“DHC developed a tailored validation concept together with us, which was then successfully implemented and audited. The collaboration so far has been outstanding, and we would gladly rely on the expertise of DHC’s experts for future projects.”
“The collaboration with DHC was always goal-oriented and very pleasant. Thanks to the high expertise in GMP and CSV as well as the development of a suitable risk management and framework, Hamilton Bonaduz AG was able to become the first Swiss life science company to achieve successful validation completion for Microsoft Dynamics D365FO in Switzerland.”
Frequently Asked Questions about Cloud & SaaS Validation
Can cloud and SaaS systems generally be used in a GxP-compliant manner?
Yes – cloud systems can be operated in a GxP-compliant manner if governance, responsibilities, data integrity and validation processes are clearly regulated. Crucial is a structured validation and governance model that considers both regulatory guideline requirements and the particularities of cloud-based platforms.
Who bears the regulatory responsibility with SaaS?
Regardless of the cloud service model, the overall regulatory responsibility always remains with the regulated company. Even when operations and maintenance are performed by the provider, companies must ensure that validation, data integrity and compliance requirements are met.
How can automatic updates and short release cycles be controlled from a regulatory perspective?
Cloud providers update systems regularly. Companies must therefore establish structured release and change processes to evaluate changes, analyze risks and perform re-validations when necessary. Modern CSV strategies integrate these processes directly into the lifecycle management of cloud-based systems.
How do you validate cloud systems to which there is no full technical access?
Validation is performed through a risk-based assessment of the deliverables provided by the vendor, such as SOC reports, certificates or validation documentation. Additionally, clear contractual agreements, defined governance processes and regular reviews are required to ensure compliance and auditability.
What role does supplier and sub-service provider management play in cloud systems?
Cloud platforms often consist of complex supply chains with multiple service providers. Companies must therefore include not only the main provider but also relevant sub-providers in their supplier management and compliance assessment. Regulatory guidelines expect transparency across the entire service supply chain.
What regulatory guidelines apply to cloud validation?
The validation of cloud-based systems continues to be guided by established regulatory guidelines such as GAMP 5, EU GMP Annex 11 and FDA 21 CFR Part 11. These particularly require risk-based validation, supplier assessment, system control, and ensuring data integrity and audit trails.
When should companies review their cloud validation strategy?
- Introducing new cloud or SaaS platforms
- Migrating existing systems to the cloud
- Increasing release and change cycles
- Growing system integration or international scaling
Cloud & SaaS Validation