Add perfection to incidence detection & reporting system

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.

Key Benefits

  • Compliance with pharmaceuticals and biotech industry regulations including GMP, 21 CFR part 11 and EMEA
  • Improves efficiency and reduce operational costs of managing change control implementation activity
  • Inter departments and Intra department transparency at operational level is greatly improved
  • Accountability can be maintained with work-flows and assignments
  • Offers controlled environment without sacrificing flexibility
  • Web based system can be accessed across sites without individual installations
  • Central database provide full control and traceability from regulatory perspective.