DEsign Qualification

Hello! we bouth a UV VIS device. What should the documents look like? Design Qualification, operational Qualification. I am really new in the field. Does anyone have an example for which device, UV VIS or HPLC or…for more orientation.?
Thank you very much
Anna

  • Draft or update risk assessment of your analytical process.
  • Draft or update user requirements specifications (URS) to document what you want the equipment to be able to do.
  • DQ: verify using the equipment specifications if the proposed equipment meets the requirements in the URS. URS+DQ are to be done prior to purchase.
  • Installation qualification (IQ): to ensure the equipment is installed properly and if you have everything (all parts, cables, user guide, CE certification etc.)
  • Operational qualification (OQ): to ensure the equipment functions as the manufacturer intended. (so according to specifications)
  • IQ/OQ is often performed by or purchased from the supplier, be sure to review the protocol before execution and add any aspects of your URS that are relevant.
  • Performance qualification (PQ): to ensure that the equipment is able to run your tests. What tests to performs is based on your risk assessment. Be sure that all aspects of your URS are addressed.
  • Draft validation summary report: summarize all activities above, including deviations and CAPA if necessary. Conclude with release statement (can the equipment be used by QC and for what)

Thank you very very much dear Claudia!


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