Validation of Microsoft Dynamics 365

Methodical, process-oriented and risk-based
DHC Best Practice Validation Method

GxP Compliance

Validation of Microsoft Dynamics 365


With Dynamics 365 for Finance and Operations, Microsoft has set a new milestone for more innovation and integration in the upper midmarket. However, the accompanying new technologies, the ever shorter innovation cycles as well as Microsoft’s affinity for cloud software/”cloud-first” strategy are challenging small and medium-sized enterprises in particular to comply with the applicable laws and guidelines in the life sciences.

  • What does this dynamic mean for the operation and validation of computer systems?
  • What is the interaction between implementation and validation?
  • Under what conditions is the use of Microsoft Dynamics 365 Cloud possible in the regulated environment?
  • What impact do releases/updates have on the valid operation of the system and on the validation method?

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Our DHC validation method for Microsoft Dynamics 365

Since 1996, we have been supporting companies in the life sciences industry (pharmaceuticals, medical technology and biotechnology) worldwide as industry experts in the validation of complex ERP systems. Thanks to our competencies in the areas of regulatory requirements and computer system validation, we are now the leading consulting firm in the German-speaking region for IT compliance.

Over the years, we have developed a cost-effective validation approach for complex ERP systems, such as Microsoft Dynamics 365 (MS D365). It is scalable, risk-based and process-oriented and also meets the high requirements for the validation of cloud systems.

Our validation methodology is fully integrated into the implementation approach and follows industry standards such as ISPE’s GAMP. The focus is on the main risks, with the aim of reducing the effort required for testing and documentation. The requirements of different regulations (e.g. FDA CFRs, EU-GMP Annex 11) and standards (e.g. ISO 13485) are taken into account.

The integrated building blocks of our approach ensure the foundation for a cost-efficient and audit-proof validation of Microsoft Dynamics 365.

DHC CONSULTING SERVICES FOR CLOUD VALIDATION

Compliance Check & Strategy

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

Validation Services

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

Managed Validation Services

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.

customer reference

“Hamilton implemented the ERP project Microsoft Dynamics D365 for Finance and Operation together with MS SharePoint 2016 for its group in 2017 to 2018. DHC AG, Switzerland as a subject matter expert for validation projects was selected as a partner and supported Hamilton AG. (…) As a result, Hamilton Bonaduz AG was the first Swiss company in the life science sector (medical device, IVD) to report successful validation completion for the implementation of Microsoft Dynamics D365FO in Switzerland. The support of DHC AG contributed significantly to the achievement of this goal.”

Rolf Gaupmann, ICT Compliance Manager, Hamilton Bonaduz AG

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Learn more about the validation of Microsoft Dynamics 365!

WHY CHOOSE DHC?

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

  • More than 25 years of expertise in software validation in pharmaceuticals 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, DHC GmbH
Swtzerland
Carsten Buri

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

Carsten Buri, DHC AG
Request information!

Learn more about our consulting services for GxP Compliance!

CUSTOMERS

WEBINARS AND EVENTS

28. Januar
Web session (in German)

Validation of SAP S/4HANA on-premise and Private Cloud Edition

The webinar looks at the validation requirements for SAP S/4HANA on-premise vs. cloud systems.

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04. Februar
Web session (in German)

UDI: Implementing global requirements with the right strategy and software

Implementation of the UDI requirements based on the SAP Cloud Platform with the UDI Platform of p36

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10. Februar
Web session (in German)

Your journey to the secure Microsoft Cloud for Pharma, Medical Technology and Biotech

Overview of the key success factors for security on the path of regulated companies to the Microsoft Cloud

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11. Februar
Web session (in German)

New ISPE GAMP® Good Practice Guide: Enabling Innovation

What does the new ISPE Guide mean for Computer System Validation (CSV) or Computer Software Assurance (CSA)?

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18. Februar
Web session (in German)

QM in S/4HANA – Example of an integrated LIMS in a Customer Project

Presentation of the quality-relevant processes of a LIMS in a customer project with the help of SAP QM as an integrated overall solution.

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10. März
Web session (in German)

SAP S/4HANA Implementation and Validation in Life Sciences

Find out what benefits the LSA approach offers you for the optimal, validated deployment of S/4HANA.

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