Deviation handling has a crucial 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.
Sarjen’s QEdge eQMS has well-designed deviation management, available ready to use. In Sarjen’s QEdge eQMS, each deviation is addressed and investigated systematically, defining 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 compliance with Part 11, US FDA and EU GMP and other global regulatory guidelines.
Sarjen’s QEdge eQMS delivers comprehensive deviation reports at any time along with trending, irrespective of where in the organization the deviation has occurred.