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.