GAMP5 validation for Dynamics 365
A detailed approach for Good Automated Manufacturing Practice (GAMP5)
With its inherent ability to start small and scale up, Microsoft Dynamics 365 is an ideal enterprise resource planning (ERP) solution for pharmaceutical and medical device manufacturers. Dynamics 365 provides a single database and application for all countries, companies, products, customers, vendors and various business models, avoiding the complexity often seen with older ERP platforms that integrate but still require multiple databases and extensive master data management. In addition, RSM has extended Dynamics 365 to support companies in computer system validation and change management.
RSM has developed last-mile solutions to support life sciences companies during the validation process for 21 CFR Part 11 (electronic signatures), 201, 211 (cGMP) and 820 (quality). Aligning with the FDA’s recommendation for a risk-based approach, our solutions balance the adherence to regulations with a change management approach that provides more flexibility to meet changing business requirements.
Read our white paper to understand the who, when, why, what and how-to-validate questions, as well as our validation deliverables. The document details the GAMP5 validation approach followed by RSM, from the foundational validation master plan, risk management plan and assessment, and supplier audit through go live.
In addition, the document provides insights into additional key processes, including:
- Traceability: You must know which supplier lots were used in which finished goods, and who received those goods to track problem products through all stages
- Change control: Any changes to computer systems used to make cGMP products and any changes to computer systems used to make decisions about products must be documented
- Surviving an FDA audit: Keys to a successful audit include reviews of record keeping, security and documentation, as well as employee training