How to Accomplish FDA Validation for ERP Software
Implementing ERP software for GxP processes into an FDA-regulated business or organization requires FDA validation. The Food and Drug...
Serving all phases of the drug development cycle
Pharmaceutical companies need to look beyond standard ERP functionality to include core industry-specific requirements such as FDA Validation, serialization, traceability, the raw material supply chain, 3rd party logistics (3PLs), contract manufacturing organization (CMOs), contract packaging organization (CPOs), contract research organization (CROs), quality management system (QMS), laboratory information management systems (LIMS), project accounting, and compliance (i.e., 21 CFR Part 11, ASC 606). In most cases, you'll need to implement an integrated best-of-breed ERP solution specific to your business needs.
With twenty-one years of software experience and implementations for dozens of pharmaceutical companies, John Hannan LLC understands how to make your ERP vision a reality. Our principal consultant has implemented over 10 different ERP solutions and is certified by Microsoft for Microsoft Dynamics Financials and Trade & Logistics, and the Project Management Institute as a Project Management Professional (PMP).
Excerpts on Pharmaceuticals from our ERP Visions Blog
Want to learn more? See more Pharmaceuticals posts from our ERP Visions blog.