Implementing MS Dynamics 365 Projects in an FDA -Validated State: Key Considerations and Expert Solutions

Summary:

(For the full version of the post below, please read it on John Hannan LLC’s Blog)

Implementing Microsoft Dynamics 365 projects in an FDA-validated state for Life Sciences companies involves considering Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in line with ERP implementation. Determining compliance with FDA Good Practices guidelines, especially Good Manufacturing Practices (GMP), is crucial beforehand. IQ ensures proper software installation, OQ involves detailed performance testing, and PQ requires on-site testing for user perspective.

IQ ensures software is installed according to specifications, requiring careful planning during both test environment installation and production environment provisioning. OQ demands detailed performance test scripts to comply with FDA guidelines, adding complexity and time to the project plan. PQ, conducted at user locations, provides a full representation of system functionality from an end-user perspective, necessitating thorough resource planning and scheduling.

Though FDA Validation adds complexity and time, it ensures compliance and system quality, enhancing overall outcomes. John Hannan LLC offers expertise in ERP implementation, upgrades, and add-on solutions for organizations seeking efficient and compliant ERP systems.

If you're considering ERP implementation or upgrades, contact John Hannan LLC for tailored solutions and expert guidance.

 

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