The Soft Solution Cim-Process Engineering

Validation is applied to many aspects of pharmaceutical manufacture, including services, equipment, systems, processes, and cleaning. In each case the objective is to produce documented evidence, which provides a high degree of assurance that all parts of the facility will consistently work correctly when brought into use.

General validation activities :

  • Planning
  • Specifications (URS, FS, SDS, HDS)
  • Test planning (preparing test documents)
  • Testing (IQ,OQ,PQ) including UT, IT, FAT, SAT
  • Review and Report

The responsibilities for supplying these documents are divided between the End user and the Supplier of the equipment.

Each one of our projects can be managed to meet GAMP4 standards, so following a life cycle model for the validation of automated control systems (FS,SDS,HDS,UT,IT,FAT & SAT).

Our service support team can provide IQ and OQ protocols and execute these on site as a part of the customer's validation master plan if needed.

We can also provide a complete validation service.

Please look up our web page PROJECT MANAGEMENT for more information