Validation – URS, DQ, IQ, OQ, PQ, RTM

When it comes to the validation of isolators, we can offer both the drafting of protocols and also the execution, where appropriate. We can also review protocols drafted by others. Such validation protocols include:

  • User Requirement Specification (URS)
  • Request for Tender (RFT) and review of tender bids
  • Review of the Functional Design Specification (FDS)
  • Design Qualification (DQ)
  • Factory Acceptance Test (FAT)
  • Installation Qualification (IQ)
  • Operation Qualification (OQ)
  • Performance Qualification (PQ)
  • Development and monitoring of the Requirement Traceability Matrix (RTM)

We are at pains to keep validation protocols focussed, and as concise as practical.  This makes them easy to follow, and thus expedites regulator approval. We are keen to avoid validation becoming a box-ticking exercise.