Validation of SAP DM

With SAP Digital Manufacturing to Cloud MES
for the Life Sciences

Validation of the SAP Digital Manufacturing Cloud (SAP DM)


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.

DHC CONSULTING SERVICES FOR SOFTWARE VALIDATION

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

.

DHC – YOUR SPECIALISTS FOR SOFTWARE VALIDATION

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.


We analyse the GxP requirements relevant to you and specify the necessary measures pragmatically based on risk analyses. DHC is characterised not only by its excellent knowledge of computer systems, but especially by its know-how in project and process management as well as its sound industry experience in the life sciences (especially pharmaceuticals) and medical technology.

DHC offers a uniform, methodical, process-oriented and risk-based validation approach. We are guided by the V-model according to the current version of GAMP, the ISO standards and requirements of the FDA (especially 21 CFR Part 11) and the European authorities (especially EU GMP Guide Annex 11). Our approach is tailored to the needs of our customers and fulfils all criteria for a cost and benefit optimised approach. In addition, we take into account the integration into an existing quality management system.

DHC’s portfolio of software validation services  is based on a maturity model for the validation of computer systems: services are offered to support strategic planning and methodological design, to professionally carry out software validation and to permanently ensure the valid state of relevant computer systems.

The service offer consists of standardised “consulting packages” pre-defined in their respective scope of services; it also includes flexibly scalable services for the implementation of validation projects and for needs-based support in company-internal validation projects. The focus is on efficiency in implementation and the sustainability of the results achieved.

WHY CHOOSE DHC?

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
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

Matthias Bothe
Switzerland
Carsten Buri

CEO and Director Sales & Marketing, DHC Switzerland

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

Carsten Buri
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