Validation of SAP DMC

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

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

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