Add perfection to incidence detection & reporting system

In generic pharmaceuticals manufacturing environment and from regulatory compliance perspective it is important that there are established procedures and records to identify and manage various deviations which have taken place.

Variations such as, not followed procedures, out of specifications can be managed for the complete life cycle which can be noted as a deviation or result in investigations, root cause analysis, CAPA and/or change control. Features like audit trail, data integrity, electronic signature and electronic records leads to better regulatory compliance in comparison to manual approach.

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.