Validation of Microsoft Dynamics 365

In a large number of projects, we have become acquainted with and optimised various methods for the validation of computer systems. Based on this experience, we have developed the DHC Best Practice Method.

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

• Fit-Gap Inspection Readiness Analysis of your validation framework as well as your validation documentation (Friendly Audits / Compliance Checks)
• 21 CFR Part 11 & EU GMP Annex 11 Assessment
• Data Integrity Assessment

• Development of remediation plans, e.g. adapting your risk-based validation strategy to new regulatory requirements
• Building a paperless validation platform
• Supplier qualification for SaaS providers
• Software validation / IT compliance workshops
• Development of testing strategies
• Development of data migration and verification strategies
• Coaching of QA / validation managers

We offer the following validation services:

• Qualification or auditing of the cloud service provider: This forms the foundation for the MS D365 validation.
• Prospective MS D365 Validation:
  Your Microsoft ERP system and the business processes mapped onto it are validated during implementation.
• Retrospective MS D365 validation:
  Microsoft ERP systems in productive use and the business processes mapped to them are validated during ongoing operation.
• Turnkey implementation of validation-remediation projects for the purpose of audit readiness
• MS D365 software validation method: Framework with work instructions for validation are created, implemented and trained.

We either validate based on your work instructions or have our DHC best practice method in place. Our validation services include taking over all validation activities – from project management to document creation – and include:

• Conception of validation strategy, plan and report
• Creation / review of life cycle documents
• Requirement management and process mapping
• Project management
• Training management
• Test management
• Data migration and data verification strategies
• Change Management
• Periodic review
• Supplier management
• Audits of suppliers and service providers

With our “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 needs. 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 draw on over 25 years of experience in this field.
Detailed info on managed services for validation can be found here.