For effective conclusion of quality deviations

Investigation is an effective tool for identification of root cause for the potential issues observed in an organisation. It ensures creation and effective management of investigation for identification of root cause. A configurable workflow design in place with defined responsibilities at each stage for speedy and effective conclusion in a time bound manner.

Quality related deviations and incidents in regulatory environment demand and effective root cause investigation for effective CAPA management and avoid reoccurrence of deviation and complaints.

QEdge provides complete and transparent management of investigation with full traceability on the source and implementation effectiveness.

QEdge, as a root cause investigation management software also offers in-built flexibility to design and implement the system in such a way, that in-between processes and work-flow within the organization can be customised under investigation management software solution.

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