Validation Support

IMA EDWARDS can draw upon extensive, hands-on operations experience to help get your new installation or freeze drying process up and running and qualified—on time and within budget. 

Qualification documents and execution from us will not only reduce the customer equipment validation time, but will provide multiple opportunities for your personnel to attend testing performed by trained technicians. This normally helps your operators gain a better understanding and comprehension of the new machine and process.

IMA EDWARDS can provide you with an omni-comprehensive package of documentation for on-site validation. The package can include DQ, IQ, OQ and PQ protocols and support by specialists for execution.

IMA EDWARDS can support your equipment qualification with a variety of different approaches:

• Integration between commissioning and qualification.
  Based on written procedures, approved by you, we define rules (deviation management, project change control, etc.) to limit the duplication of effort between FAT/SAT and IQ/OQ/PQ.
• Risk analysis.
  Through the analysis of the critical process parameters and written rationale, we support you in defining the scope of the qualification, setting up initial and periodic qualification programmes, and integrating the commissioning and qualification efforts.

IMA EDWARDS will frame the commissioning and qualification effort within the customer validation master plan.