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?
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.
Currently, we are conducting a Microsoft D365 validation for HSO, one of the largest Microsoft implementation partners in the world. In the following YouTube video, our DHC validation expert, Stefan Staub, and Matt Birtwistle, Engagement Director at HSO, discuss Microsoft D365 validation for life sciences companies.
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
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
Data migration and data verification strategies
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.
Rolf Gaupmann, ICT Compliance Manager, Hamilton Bonaduz AG
„Hamilton hat das ERP-Projekt Microsoft Dynamics D365 for Finance and Operation zusammen mit MS SharePoint 2016 für seine Gruppe im Zeitraum 2017 bis 2018 eingeführt. DHC AG, Schweiz als Fachexperte für Validierungsprojekte wurde als Partner ausgewählt und unterstützte die Hamilton AG. (…) Als Ergebnis konnte die Hamilton Bonaduz AG als erste Schweizer-Firma im Bereich Life-Science (Medical Device, IVD) den erfolgreichen Validierungsabschluss für die lmplementierung von Microsoft Dynamics D365FO in der Schweiz vermelden. Die Unterstützung von DHC AG hat wesentlich zu dieser Zielerreichung beigetragen.“
Mohammad Anwar Hossain, Project Manager, SAP project ‘UTTORON’, Deputy General Manager, IT, Incepta Pharmaceuticals Ltd., Dhaka
“DHC made the most effective job in our project. Many of their activities not only assured the goal of a prospective validation of SAP ERP ECC 6.0, but also reduced the project risk. Due to the structured approach with SAP processes and business scenarios and defining the business requirements in URS documents, we were pretty sure, that the new ERP system will cover the daily business of Incepta.”
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