All data generated to satisfy a CGMP requirement is a CGMP record. The data integrity guidance states that in order to comply with CGMP requirements with manufacturing processes, you must document or save recorded data at the time a task or process is performed. Also, all data that is recorded and maintained cannot be modified or discarded.
An EQMS can be configured to automatically save record data after each separate entry. Automation makes it easier to comply with CGMP standards because all records and data are automatically tracked and updated. This makes finding and retrieving records during audits much faster.
The data integrity guidance does go beyond the standard CGMP requirements because of the criticality of data integrity. Although the guidance is not binding, the Agency tends to rely on guidances during inspections and making enforcement decisions (2). An EQMS will enable you better ensure data integrity, maintain an audit-ready state and more easily comply with the regulations that are required.
