Validation of
SAP Digital Manufacturing
- GxP and IT Expertise from a Single Source
- 30+ Years of Experience in Regulated Industries
- SAP Silver Partner
Validation of SAP DM
SAP Digital Manufacturing (SAP DM) is SAP’s cloud-based MES solution and forms the foundation for the digital factory. As a Software-as-a-Service (SaaS), SAP DM controls and monitors production processes in real-time and enables end-to-end integration between the shopfloor and SAP S/4HANA.
For companies in the pharmaceutical and medical technology industries, this poses a central challenge:
Cloud-based production systems must be validated in a GxP-compliant manner and operated in an audit-ready way despite high dynamics, releases and shared responsibility.
DHC supports companies in validating SAP DM efficiently and in a regulatory-compliant manner – from implementation to stable operations.
Challenges in the Validation of SAP DM
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.
Integration of Production and IT
SAP DM connects shopfloor, MES and ERP – this integration must be consistently validated and documented.
DHC Best Practice for Cloud System Validation
The validation of SAP DM requires a risk-based and cloud-specific approach that takes into account the particularities of SaaS systems.
DHC combines in an integrated approach:
- Computer System Validation (CSV)
- SAP and MES expertise
- Cloud and operating models
The focus is on:
- Validation across the entire system lifecycle
- Consideration of release and change processes
- Integration of business processes and system functions
This creates an efficient, audit-ready and scalable validation of SAP Digital Manufacturing.
Overview of DHC Validation Services for SAP DM
DHC Consulting Services
Validation Strategy & Concept
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
For the digitalization of validation processes, DHC developed the Smart Validation Accelerator.
The platform supports companies in efficiently managing validation processes across the entire system lifecycle and documenting regulatory evidence in an audit-ready manner.
Through integration into the SAP ecosystem (SAP Cloud ALM, Tricentis) and the use of AI-supported automation, validation processes can be significantly accelerated.
The DHC Smart Validation Accelerator is also part of the SAP initiative for developing an End-2-End Digital Validation Platform.
Why DHC?
DHC is among the leading specialists for the validation of SAP systems in regulated industries.
Our customers benefit from:
- Over 30 years of experience in computer system validation
- Deep understanding of SAP and MES systems
- Expertise in cloud and SaaS validation
- Integrated methods for transformation and compliance
We combine SAP, production and compliance – for stable and audit-ready system landscapes.
Validation of SAP Digital Manufacturing
Trust through Experience
We are the specialist for Cloud & SaaS Validation.
Validation of SAP DM at Carl Zeiss
In a joint project with Carl Zeiss, the SAP pilot customer for the use of SAP Digital Manufacturing (SAP DM) in the regulated environment, we were responsible for the validation of SAP’s MES Public Cloud solution. We are pleased that ZEISS was awarded the SAP Innovation Award 2023 for this project.
As part of the digital transformation to automate the Connected Smart Factory, ZEISS used the Public Cloud SaaS solution SAP Digital Manufacturing (SAP DM) and SAP Business Technology Platform (BTP) services to create three Manufacturing Execution System (MES) templates for different production types. DHC Consulting was responsible for defining the validation approach and validating the templates and the plant’s backend infrastructure to ensure integration with the manufacturing level.
The new digital automation solution ensures high production efficiency and regulatory compliance by automating data collection from machines and operators, precisely measuring environmental controls, creating digital documentation to eliminate paper usage, and providing an accessible single source of truth.
The defined templates and pilot implementation formed the basis for a company-wide rollout across all production lines.
The rollouts are carried out in agile sprints, and DHC Consulting, together with the project team, developed an industrialized validation process to validate the frequent sprint releases in an efficient and compliant manner.
A public cloud SaaS solution also brings frequent functional product releases. Therefore, the project team mapped the SAP DM functions to the MES processes to enable efficient and effective change impact analysis for new product releases.
Frequently Asked Questions about SAP DM Validation
What is SAP Digital Manufacturing (SAP DM)?
SAP DM is a cloud-based MES solution that controls, monitors and analyzes production processes and serves as a central platform for the digital factory.
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
Validation of SAP Digital Manufacturing
Would you like to ensure regulatory compliance for your cloud strategy without slowing down innovation?