Deviation management is a key role in assuring product Quality, Purity and Strength. Any non-compliance of an established GMP standard or of approved requirements, specifications and standard operating procedures (SOPs) needs to be identified, recorded and evaluated. Any critical or major deviation which affect the product quality, reliability of procedure or records should be investigated and resolved. Organizations can depend on the software for a complete audit trail that supports compliance with part 11 requirements. The system also supports e-signatures, data integrity, and data security for better compliance.

The system supports integration with the Document Management System to help users easily access supporting documents, pre-saved templates and Standard Operating Procedures (SOPs) relevant for deviation management.

Sarjen’s QEdge EQMS has well-designed deviation management, available for ready to use. In Sarjen’s QEdge EQMS, each deviation is addressed and investigated systematically, identifying the root cause analysis and when and how immediate actions, corrective actions, or preventive actions (CAPA) have been taken to prevent recurrence.

Sarjen’s QEdge EQMS delivers critical quality data in timely manner and enables quick response to potential failures in GMP compliance and global regulatory guidelines.

Sarjen’s QEdge EQMS delivers comprehensive deviation reports at any time along with trending, irrespective of wherein the organization the deviation has occurred.