Helps to achieve transparent & improved complaint analysis

With respect to US FDA Section 820.3 (b) of Quality system regulation define, Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

Sarjen’s QEdge eQMS offers an effective complaint process to respond quickly to the issues raised internally or externally. Systematic evaluation and root cause analyses will help to prevent recurring of complaints. It identifies the actions (CAPA) to correct the problem and verify the effectiveness of this action.

Not just product related complaints – packaging or quality or others but, also pharmacologic complaints also can be successfully handled in the comprehensiveness of Sarjen’s QEdge eQMS Market Complaint.

Key Benefits

  • Compliance with pharmaceuticals and biotech industry regulations including GMP, 21 CFR part 11 and Annex 11
  • Improve response time which in-turn helps in corporate image
  • Improves efficiency and reduce operational costs of managing change control implementation activity
  • Inter departments and Intra department transparency at operational level is greatly improved
  • Helps in avoiding repeat issues
  • 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