Your GMP Risk processes controlled by the ERP system must be validated.
As an organization that is under FDA regulations, you must go through a validation project. The process of validation determines, defines, governs and documents the formal testing of GMP relevant activities pertaining to the definition, production, and delivery of regulated products and services. If unclear as to which areas of your business this applies to, the FDA does provide the following guidance:
Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use. This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.
When implementing a new ERP solution to improve your company’s business processes, it is therefore essential that your FDA validation and your ERP Go-Live are concurrent events!