The software itself is not certified according to GMP. These ‘Good Manufacturing Practices’ are based on how the production process is organized within the organization. This is specific to each organization.
An audit is conducted to assess whether the manufacturer and its business processes meet the established requirements. One of those processes is the IT system and how it is used to monitor quality.
Exact Globe includes features that are part of GMP certification. These include capabilities for tracking changes, data security, and traceability. Exact Synergy It also offers a document management system that complies with GMP guidelines.