What makes your enterprise resource planning (ERP) requirements difficult for most vendors to satisfy? As a life sciences company, you have operational processes that set you apart from other manufacturing companies. And, your regulatory requirements, including 21 CFR part 11, aren’t like those of any other industry. The challenge is to manage compliance risks and compliance costs. Learn about an ERP compliance strategy.
erp fda regulatory compliance
all areas of the ERP system that are FDA significant, including batch records, engineering changes, quality records, inventory status transactions, process instructions and recording of results. The infrastructure approach gives the business control over its approach to compliance. For example, a hard-coded compliance solution might require an electronic signature when signing off on a data entry to a batch record, even if the business keeps a paper batch record. The Merit solution infrastructure