Validation of SAP DM / | EN

The SAP Digital Manufacturing Cloud (SAP DM) is SAP’s new MES cloud solution. On the way to the smart or digital factory, SAP DM sets new standards as a SaaS manufacturing cloud solution and ensures more quality and efficiency in manufacturing. Like all computer-based systems, SAP DM must be validated and kept valid during operation when used in the highly regulated pharmaceutical industry and medical technology.

Thanks to our many years of experience in the validation of computer-based systems, we know what needs to be taken into account in the individual phases of the system life cycle when deploying GxP-relevant systems in a public cloud deployment model. We focus on the differences and challenges compared to on-premise applications, such as shared responsibility, supplier management, release management.

Based on our experience, we have developed a cost-efficient and scalable software validation methodology over the years. The DHC Best Practice Method is a framework consisting of a process model, work instructions (SOPs), templates, training documents and tools. It covers the entire system lifecycle from initial implementation, through the operational phase, to decommissioning and data archiving.

We have further developed this method for cloud-based systems. We take into account the special characteristics of these systems, such as the user’s reduced control over the system, the management of the service provider or software supplier, the protection of the data in the system and the frequent software changes by the provider.

Compliance Check & Strategy

In a variety of projects, we have learned about and optimised different methods for validating computer systems. These are basically applicable to cloud-based solutions. A critical aspect in the use of cloud-based systems is the selection, use and management of the service providers or software suppliers as well as the release management due to software changes for which the software supplier is responsible. These aspects are particularly taken into account here.

Our consultants will gladly and competently support you in the following topics:

Supplier selection and qualification incl. supplier or service provider audits
Review of the Master Service Agreements or Service Level Agreements
Development of validation strategies taking into account the delivery objects of the cloud service suppliers

Fit-Gap Inspection Readiness Analysis of your validation framework and documentation (Friendly Audit / Compliance Check)
21 CFR Part 11 & EU GMP Annex 11 Assessments
Data Integrity Assessment
Development of remediation plans, e.g. adapting your risk-based validation strategy to the challenges of cloud-based systems
Development of a MES detailed process on DM functions matrix to efficiently perform change impact analysis in the context of release management
Design of validation framework work instructions, templates and training documents
Software validation / compliance workshops

Validation Services

The core of our Validation Services is the risk-based and economic execution of the validation of your cloud-based systems. We validate either according to your work instructions or, on request, according to the DHC best practice method. We offer the following implementation services:

Qualification or auditing of the cloud service provider
Creation of a service level agreement (SLA) or quality agreement with the cloud service provider
Validation of the software systems and the business processes mapped onto them during implementation
Turnkey implementation of validation remediation projects for the purpose of audit readiness
Software validation methodology: framework with work instructions is created, implemented and trained.

Our Validation Services include taking over all validation activities – from project management to document production – and include:

Creation of validation strategy, plan and report
Creation / review of life cycle documents
Project management
Training management
Test management
Data migration and data verification strategies
Change management
Release management
Regression testing
Periodic review
Supplier management
Audits of suppliers and service providers

Managed Validation Services

With our “DHC Managed Services for Validation” the effort and costs of IT Compliance can be reduced and made transparent. Depending on the initial situation, we offer service packages in the area of Managed Validation Services that are specially tailored to your customer requirements. These range from targeted support (Validation as a Service = VaaS) to a full service package

Depending on the desired level of support, we provide the necessary compliance concept, methods and resources for achieving and maintaining IT compliance. In doing so, we rely on more than 20 years of experience in this area

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Since 1996, we have gained a wealth of experience in the prospective and retrospective validation of a wide range of complex computer systems, such as ERP systems, document management systems, clinical trial software, LIMS, and many more.

In a joint project with Carl Zeiss, SAP’s pilot customer for using SAP Digital Manufacturing (SAP DM) in a regulated environment, we were responsible for validating SAP’s MES Public Cloud solution. We are delighted that ZEISS won the SAP Innovation Award 2023 for this project.
As part of the digital transformation to automate the Connected Smart Factory, ZEISS used the SAP Digital Manufacturing (SAP DM) public cloud SaaS solution 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 back-end infrastructure to ensure integration with the shop floor.

The new digital automation solution ensures high levels of production efficiency and regulatory compliance by automating data collection from machines and operators, accurately measuring environmental controls, creating digital documentation to eliminate paper consumption, and providing an accessible single source of data.
The defined templates and pilot implementation formed the basis for a company-wide rollout across all production lines.
The rollouts are performed in agile sprints, and DHC Consulting worked with the project team to develop an industrialised validation process to validate the frequent sprint releases in an efficient and compliant manner.
A public cloud SaaS solution also entails frequent functional product releases. Therefore, the project team mapped the SAP DM functionality to the MES processes to enable efficient and effective analysis of the impact of changes in new product releases.

Benefit from our methodical, process-oriented and risk-based validation approach to software validation

More than 25 years of expertise in computer system validation in pharmaceuticals/life sciences and medical technology
Numerous successfully completed prospective and retrospective validation projects
Scalable DHC Best Practice Validation Method / Validation Content
High audit reliability
Strong team of CSV managers with profound knowledge of regulatory requirements (GAMP, FDA, GxP, ISO 13485, …)
Long-term and trusting cooperation with our customers
Ensuring the transfer of knowledge to you as a customer